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20-06-2025
- Business
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Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline
The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine tumors. Advancements in antibody-drug conjugate (ADC) technology and increasing clinical trial activity are propelling the development of DLL3-targeted candidates. Growing interest from biopharma companies and strategic collaborations are also accelerating the DLL3-targeted therapies market expansion. LAS VEGAS, June 19, 2025 /PRNewswire/ — DelveInsight's Delta-like Ligand 3 Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging delta-like ligand 3 targeted therapies, market share of individual therapies, and current and forecasted delta-like ligand 3 targeted therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Delta-like Ligand 3 Targeted Therapies Market Report As per DelveInsight's analysis, the total market size of delta-like ligand 3 targeted therapies in the 7MM is expected to surge significantly by 2034. The approval of the first DLL3-targeted Bispecific T-cell Engager therapy, IMDELLTRA, by the US Food and Drug Administration (FDA) in May 2024 marked a pivotal moment for patients battling Extensive-stage small-cell lung Cancer (ES-SCLC). Leading delta-like ligand 3 targeted therapies companies, such as Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, and others, are developing novel delta-like ligand 3 targeted therapies that can be available in the delta-like ligand 3 targeted therapies market in the coming years. Some of the key delta-like ligand 3 targeted therapies in the pipeline include Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, and others. In February 2025, Phanes Therapeutics announced that the first patient was dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. In September 2024, Abdera Therapeutics announced that the US FDA granted ODD to ABD-147 for the treatment of NEC. In August 2024, Daiichi Sankyo and Merck expanded their existing global co-development and co-commercialization agreement for Merck's MK-6070 for the treatment of SCLC. Discover which indication is expected to grab the major delta-like ligand 3 targeted therapies market share @ Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Market Dynamics The delta-like ligand 3 targeted therapies market is emerging as a dynamic and promising area in oncology, particularly for hard-to-treat cancers like SCLC and other neuroendocrine tumors. With a growing understanding of its role in tumorigenesis, drug developers have shifted focus toward exploiting this target through various modalities, including ADCs, BiTEs, and CAR-T cell therapies. The FDA approval of tarlatamab (IMDELLTRA), a DLL3-targeted BiTE, has catalyzed commercial and clinical interest in this space. The competitive landscape is rapidly evolving, driven by both established pharmaceutical players and biotech innovators. Several companies are advancing DLL3-targeted assets through clinical pipelines, highlighting the growing investment and belief in the target's therapeutic value. Tarlatamab, in particular, has set a precedent by demonstrating durable responses in patients with extensive-stage SCLC who have limited treatment options after frontline chemotherapy. Its clinical success has validated DLL3 as a viable target and opened the door for additional programs in earlier lines of therapy and combination regimens. However, the DLL3-targeted therapy market faces challenges that could shape its trajectory. The heterogeneity of DLL3 expression among patient populations, potential for resistance mechanisms, and safety concerns, especially cytokine release syndrome (CRS) in immune-engaging therapies, are critical issues under active investigation. Additionally, biomarker-based patient selection strategies are essential to optimize efficacy, which may limit the addressable population unless companion diagnostics evolve in parallel. Market dynamics are also influenced by the broader shift toward personalized and immune-based treatments. The rise of bispecific and cell-based platforms enhances the flexibility in targeting DLL3, but also introduces manufacturing and logistical hurdles. As such, scalability, cost-effectiveness, and global accessibility will be important considerations in the commercial rollout. Reimbursement strategies and payer acceptance will further impact uptake, especially given the premium pricing associated with novel biologics. Looking ahead, the DLL3-targeted therapies market is poised for expansion beyond SCLC. Preliminary studies are exploring DLL3 expression in other neuroendocrine carcinomas, prostate cancer, and some pediatric tumors. This potential for label expansion, coupled with advancing drug formats and supportive regulatory pathways, indicates a robust growth trajectory. As the clinical pipeline matures and real-world data accumulate, DLL3-targeted approaches are expected to play an increasingly integral role in the precision oncology landscape. Delta-like Ligand 3 Targeted Therapies Treatment Market DLL3-targeted therapies are emerging as a promising new approach in the treatment of small-cell lung cancer and neuroendocrine carcinomas, bringing renewed optimism for patients with these aggressive cancers. A major breakthrough came in May 2024, when the US FDA approved IMDELLTRA, the first bispecific T-cell engager therapy targeting DLL3. Developed by Amgen, this first-in-class immunotherapy is designed to bind DLL3 on tumor cells and CD3 on T cells, triggering a T-cell–mediated attack on DLL3-expressing cancer cells through the formation of a cytolytic synapse. The approval and subsequent launch of IMDELLTRA have been widely recognized as a significant advancement in DLL3-focused treatments, generating approximately USD 115 million in US sales in 2024. This therapy offers a game-changing option for patients with previously treated Extensive-stage SCLC, showing durable responses. As the second FDA-approved BiTE molecule from Amgen, IMDELLTRA underscores the company's commitment to tackling hard-to-treat cancers. For patients urgently needing new therapeutic solutions, this approval delivers a much-needed and long-awaited source of hope. Learn more about the FDA-approved delta-like ligand 3 targeted therapies @ Approved Delta-like Ligand 3 Targeted Therapies Key Emerging Delta-like Ligand 3 Targeted Therapies and Companies The current pipeline is dominated with early-stage DLL-3 targeted therapies like peluntamig (Phanes Therapeutics), MK-6070/ HPN328-4001/ DS3280 (Merck / Daiichi Sankyo), LB2102/ DLL3-targeted CAR-Ts (Legend Biotech and Novartis), 225Ac-ABD147 (Abdera Therapeutics), BI 764532 (Boehringer Ingelheim), ALPS12/ RG6524 (Chugai Pharmaceutical and Roche), ZL-1310 (Zai Lab), and others. Peluntamig (PT217) is a first-in-class, native IgG-like bispecific antibody designed to target both DLL3 and CD47. It is being developed for the treatment of SCLC and neuroendocrine carcinomas, including neuroendocrine prostate cancer (NEPC). The FDA has awarded peluntamig two Orphan Drug Designations (ODDs) for SCLC and NEC, along with two Fast Track Designations (FTDs): one for extensive-stage SCLC that has progressed following platinum-based chemotherapy (with or without checkpoint inhibitors), and another for metastatic de novo or treatment-emergent NEPC. The therapy is currently undergoing evaluation in the Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC. MK-6070 is an experimental tri-specific T-cell engager targeting DLL3, under Phase I/II clinical investigation. It is being tested as a standalone therapy in patients with advanced DLL3-expressing tumors and in combination with atezolizumab for certain cases of SCLC. The FDA granted MK-6070 Orphan Drug Designation for SCLC in March 2022. In March 2024, Merck finalized its acquisition of Harpoon Therapeutics, the original developer. In August 2024, Daiichi Sankyo and Merck expanded their global partnership to include MK-6070 under their co-development and co-commercialization agreement for DXd antibody-drug conjugates. Merck retains exclusive rights in Japan and will handle all manufacturing and supply responsibilities for MK-6070. The two companies also plan to explore the use of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC, along with other potential combination strategies. The anticipated launch of these emerging therapies is poised to transform the delta-like ligand 3 targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the delta-like ligand 3 targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about delta-like ligand 3 targeted therapies clinical trials, visit @ Delta-like Ligand 3 Targeted Therapies Treatment Delta-like Ligand 3 Targeted Therapies Overview Delta-like ligand 3 (DLL3) targeted therapies is an unconventional ligand within the Notch signaling pathway that, when overexpressed, supports the growth, migration, and invasiveness of small cell lung cancer (SCLC) cells. It also contributes to the development of metastatic and therapy-resistant traits in neuroendocrine carcinomas (NECs), enhancing both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is minimal and confined to the Golgi apparatus and cytoplasmic vesicles. This specific intracellular localization is regulated by its transmembrane domain and nearby protein sequences, which serve as retention signals. In contrast, SCLC cells exhibit high levels of DLL3 that are abnormally localized to the cell surface, a characteristic observed in up to 85% of human SCLC cases. While the mechanisms behind this overexpression and altered trafficking are not fully understood, DLL3's distinct expression pattern positions it as a promising biomarker and therapeutic target in SCLC. Beyond SCLC, DLL3 is also widely expressed in various NECs, including certain molecular subtypes of pulmonary large cell NEC (LCNEC) and NECs originating from the gastroenteropancreatic tract, bladder, prostate, and cervix. In these tumors, elevated DLL3 expression correlates with more advanced disease and poorer overall survival, suggesting a strong association between high DLL3 levels and unfavorable clinical outcomes. Delta-like Ligand 3 Targeted Therapies Epidemiology Segmentation The delta-like ligand 3 targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for DLL3-targeted Therapies Total Eligible Patient Pool in Selected Indications for DLL3-targeted Therapies Total Treated Cases in Selected Indications for DLL3-targeted Therapies Delta-like Ligand 3 Targeted Therapies Report Metrics Details Study Period 2020–2034 Delta-like Ligand 3 Targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Delta-like Ligand 3 Targeted Therapies Companies Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, Amgen, and others Key Delta-like Ligand 3 Targeted Therapies Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, IMDELLTRA, and others Scope of the Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Therapeutic Assessment: Delta-like Ligand 3 Targeted Therapies current marketed and emerging therapies Delta-like Ligand 3 Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Delta-like Ligand 3 Targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Delta-like Ligand 3 Targeted Therapies Market Access and Reimbursement Discover more about delta-like ligand 3 targeted therapies in development @ Delta-like Ligand 3 Targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Market Forecast Methodology 6. Delta-like Ligand 3 Targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. Delta-like Ligand 3 (DLL3)-targeted Therapies: Background and Overview 7.1. Introduction 7.2. The Potential of Delta-like Ligand 3 (DLL3)-targeted Therapies in Different Indications 7.3. Clinical Applications of Delta-like Ligand 3 (DLL3)-targeted Therapies 8. Target Patient Pool of Delta-like Ligand 3 (DLL3)-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 9. Marketed Therapies 9.1. Key Competitors 9.2. IMDELLTRA (tarlatamab-dlle): Amgen 9.2.1. Product Description 9.2.2. Regulatory milestones 9.2.3. Other developmental activities 9.2.4. Clinical development 9.2.5. Safety and efficacy List to be continued in the report 10. Emerging Therapies 10.1. Key Competitors 10.2. Peluntamig (PT217): Phanes Therapeutics 10.2.1. Product Description 10.2.2. Other developmental activities 10.2.3. Clinical development 10.2.4. Safety and efficacy 10.3. MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo 10.3.1. Product Description 10.3.2. Other developmental activities 10.3.3. Clinical development 10.3.4. Safety and efficacy List to be continued in the report 11. Delta-like Ligand 3 Targeted Therapies: Seven Major Market Analysis 11.1. Key Findings 11.2. Market Outlook 11.3. Conjoint Analysis 11.4. Key Market Forecast Assumptions 11.4.1. Cost Assumptions and Rebates 11.4.2. Pricing Trends 11.4.3. Analogue Assessment 11.4.4. Launch Year and Therapy Uptakes 11.5. Total Market Sizes of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in the 7MM 11.6. The United States Market Size 11.6.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in the United States 11.6.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indication in the United States 11.6.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in the United States 11.7. EU4 and the UK 11.7.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in EU4 and the UK 11.7.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in EU4 and the UK 11.7.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in EU4 and the UK 11.8. Japan 11.8.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies Inhibitors in Japan 11.8.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in Japan 11.8.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in Japan 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Market Access and Reimbursement 16. Appendix 16.1. Bibliography 16.2. Report Methodology 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports Small Cell Lung Cancer Market Small Cell Lung Cancer Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. Extensive-Stage Small Cell Lung Cancer Market Extensive-Stage Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ES-SCLC companies, including Shanghai Henlius Biotech, MacroGenics, Inc., RayzeBio, Inc., Genentech, Eli Lilly and Company, Amgen, Hutchison Medipharma Limited, Biocity Biopharmaceutics Co., Ltd., Biotheus Inc., GSK, InxMed (Shanghai) Co., Ltd., Daiichi Sankyo, Merck Sharp & Dohme LLC, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
19-06-2025
- Business
- Yahoo
Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline
The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine tumors. Advancements in antibody-drug conjugate (ADC) technology and increasing clinical trial activity are propelling the development of DLL3-targeted candidates. Growing interest from biopharma companies and strategic collaborations are also accelerating the DLL3-targeted therapies market expansion. LAS VEGAS, June 19, 2025 /PRNewswire/ -- DelveInsight's Delta-like Ligand 3 Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging delta-like ligand 3 targeted therapies, market share of individual therapies, and current and forecasted delta-like ligand 3 targeted therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Delta-like Ligand 3 Targeted Therapies Market Report As per DelveInsight's analysis, the total market size of delta-like ligand 3 targeted therapies in the 7MM is expected to surge significantly by 2034. The approval of the first DLL3-targeted Bispecific T-cell Engager therapy, IMDELLTRA, by the US Food and Drug Administration (FDA) in May 2024 marked a pivotal moment for patients battling Extensive-stage small-cell lung Cancer (ES-SCLC). Leading delta-like ligand 3 targeted therapies companies, such as Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, and others, are developing novel delta-like ligand 3 targeted therapies that can be available in the delta-like ligand 3 targeted therapies market in the coming years. Some of the key delta-like ligand 3 targeted therapies in the pipeline include Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, and others. In February 2025, Phanes Therapeutics announced that the first patient was dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. In September 2024, Abdera Therapeutics announced that the US FDA granted ODD to ABD-147 for the treatment of NEC. In August 2024, Daiichi Sankyo and Merck expanded their existing global co-development and co-commercialization agreement for Merck's MK-6070 for the treatment of SCLC. Discover which indication is expected to grab the major delta-like ligand 3 targeted therapies market share @ Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Market Dynamics The delta-like ligand 3 targeted therapies market is emerging as a dynamic and promising area in oncology, particularly for hard-to-treat cancers like SCLC and other neuroendocrine tumors. With a growing understanding of its role in tumorigenesis, drug developers have shifted focus toward exploiting this target through various modalities, including ADCs, BiTEs, and CAR-T cell therapies. The FDA approval of tarlatamab (IMDELLTRA), a DLL3-targeted BiTE, has catalyzed commercial and clinical interest in this space. The competitive landscape is rapidly evolving, driven by both established pharmaceutical players and biotech innovators. Several companies are advancing DLL3-targeted assets through clinical pipelines, highlighting the growing investment and belief in the target's therapeutic value. Tarlatamab, in particular, has set a precedent by demonstrating durable responses in patients with extensive-stage SCLC who have limited treatment options after frontline chemotherapy. Its clinical success has validated DLL3 as a viable target and opened the door for additional programs in earlier lines of therapy and combination regimens. However, the DLL3-targeted therapy market faces challenges that could shape its trajectory. The heterogeneity of DLL3 expression among patient populations, potential for resistance mechanisms, and safety concerns, especially cytokine release syndrome (CRS) in immune-engaging therapies, are critical issues under active investigation. Additionally, biomarker-based patient selection strategies are essential to optimize efficacy, which may limit the addressable population unless companion diagnostics evolve in parallel. Market dynamics are also influenced by the broader shift toward personalized and immune-based treatments. The rise of bispecific and cell-based platforms enhances the flexibility in targeting DLL3, but also introduces manufacturing and logistical hurdles. As such, scalability, cost-effectiveness, and global accessibility will be important considerations in the commercial rollout. Reimbursement strategies and payer acceptance will further impact uptake, especially given the premium pricing associated with novel biologics. Looking ahead, the DLL3-targeted therapies market is poised for expansion beyond SCLC. Preliminary studies are exploring DLL3 expression in other neuroendocrine carcinomas, prostate cancer, and some pediatric tumors. This potential for label expansion, coupled with advancing drug formats and supportive regulatory pathways, indicates a robust growth trajectory. As the clinical pipeline matures and real-world data accumulate, DLL3-targeted approaches are expected to play an increasingly integral role in the precision oncology landscape. Delta-like Ligand 3 Targeted Therapies Treatment Market DLL3-targeted therapies are emerging as a promising new approach in the treatment of small-cell lung cancer and neuroendocrine carcinomas, bringing renewed optimism for patients with these aggressive cancers. A major breakthrough came in May 2024, when the US FDA approved IMDELLTRA, the first bispecific T-cell engager therapy targeting DLL3. Developed by Amgen, this first-in-class immunotherapy is designed to bind DLL3 on tumor cells and CD3 on T cells, triggering a T-cell–mediated attack on DLL3-expressing cancer cells through the formation of a cytolytic synapse. The approval and subsequent launch of IMDELLTRA have been widely recognized as a significant advancement in DLL3-focused treatments, generating approximately USD 115 million in US sales in 2024. This therapy offers a game-changing option for patients with previously treated Extensive-stage SCLC, showing durable responses. As the second FDA-approved BiTE molecule from Amgen, IMDELLTRA underscores the company's commitment to tackling hard-to-treat cancers. For patients urgently needing new therapeutic solutions, this approval delivers a much-needed and long-awaited source of hope. Learn more about the FDA-approved delta-like ligand 3 targeted therapies @ Approved Delta-like Ligand 3 Targeted Therapies Key Emerging Delta-like Ligand 3 Targeted Therapies and Companies The current pipeline is dominated with early-stage DLL-3 targeted therapies like peluntamig (Phanes Therapeutics), MK-6070/ HPN328-4001/ DS3280 (Merck / Daiichi Sankyo), LB2102/ DLL3-targeted CAR-Ts (Legend Biotech and Novartis), 225Ac-ABD147 (Abdera Therapeutics), BI 764532 (Boehringer Ingelheim), ALPS12/ RG6524 (Chugai Pharmaceutical and Roche), ZL-1310 (Zai Lab), and others. Peluntamig (PT217) is a first-in-class, native IgG-like bispecific antibody designed to target both DLL3 and CD47. It is being developed for the treatment of SCLC and neuroendocrine carcinomas, including neuroendocrine prostate cancer (NEPC). The FDA has awarded peluntamig two Orphan Drug Designations (ODDs) for SCLC and NEC, along with two Fast Track Designations (FTDs): one for extensive-stage SCLC that has progressed following platinum-based chemotherapy (with or without checkpoint inhibitors), and another for metastatic de novo or treatment-emergent NEPC. The therapy is currently undergoing evaluation in the Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC. MK-6070 is an experimental tri-specific T-cell engager targeting DLL3, under Phase I/II clinical investigation. It is being tested as a standalone therapy in patients with advanced DLL3-expressing tumors and in combination with atezolizumab for certain cases of SCLC. The FDA granted MK-6070 Orphan Drug Designation for SCLC in March 2022. In March 2024, Merck finalized its acquisition of Harpoon Therapeutics, the original developer. In August 2024, Daiichi Sankyo and Merck expanded their global partnership to include MK-6070 under their co-development and co-commercialization agreement for DXd antibody-drug conjugates. Merck retains exclusive rights in Japan and will handle all manufacturing and supply responsibilities for MK-6070. The two companies also plan to explore the use of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC, along with other potential combination strategies. The anticipated launch of these emerging therapies is poised to transform the delta-like ligand 3 targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the delta-like ligand 3 targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about delta-like ligand 3 targeted therapies clinical trials, visit @ Delta-like Ligand 3 Targeted Therapies Treatment Delta-like Ligand 3 Targeted Therapies Overview Delta-like ligand 3 (DLL3) targeted therapies is an unconventional ligand within the Notch signaling pathway that, when overexpressed, supports the growth, migration, and invasiveness of small cell lung cancer (SCLC) cells. It also contributes to the development of metastatic and therapy-resistant traits in neuroendocrine carcinomas (NECs), enhancing both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is minimal and confined to the Golgi apparatus and cytoplasmic vesicles. This specific intracellular localization is regulated by its transmembrane domain and nearby protein sequences, which serve as retention signals. In contrast, SCLC cells exhibit high levels of DLL3 that are abnormally localized to the cell surface, a characteristic observed in up to 85% of human SCLC cases. While the mechanisms behind this overexpression and altered trafficking are not fully understood, DLL3's distinct expression pattern positions it as a promising biomarker and therapeutic target in SCLC. Beyond SCLC, DLL3 is also widely expressed in various NECs, including certain molecular subtypes of pulmonary large cell NEC (LCNEC) and NECs originating from the gastroenteropancreatic tract, bladder, prostate, and cervix. In these tumors, elevated DLL3 expression correlates with more advanced disease and poorer overall survival, suggesting a strong association between high DLL3 levels and unfavorable clinical outcomes. Delta-like Ligand 3 Targeted Therapies Epidemiology Segmentation The delta-like ligand 3 targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for DLL3-targeted Therapies Total Eligible Patient Pool in Selected Indications for DLL3-targeted Therapies Total Treated Cases in Selected Indications for DLL3-targeted Therapies Delta-like Ligand 3 Targeted Therapies Report Metrics Details Study Period 2020–2034 Delta-like Ligand 3 Targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Delta-like Ligand 3 Targeted Therapies Companies Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, Amgen, and others Key Delta-like Ligand 3 Targeted Therapies Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, IMDELLTRA, and others Scope of the Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Therapeutic Assessment: Delta-like Ligand 3 Targeted Therapies current marketed and emerging therapies Delta-like Ligand 3 Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Delta-like Ligand 3 Targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Delta-like Ligand 3 Targeted Therapies Market Access and Reimbursement Discover more about delta-like ligand 3 targeted therapies in development @ Delta-like Ligand 3 Targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Market Forecast Methodology 6. Delta-like Ligand 3 Targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. Delta-like Ligand 3 (DLL3)-targeted Therapies: Background and Overview 7.1. Introduction 7.2. The Potential of Delta-like Ligand 3 (DLL3)-targeted Therapies in Different Indications 7.3. Clinical Applications of Delta-like Ligand 3 (DLL3)-targeted Therapies 8. Target Patient Pool of Delta-like Ligand 3 (DLL3)-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 9. Marketed Therapies 9.1. Key Competitors 9.2. IMDELLTRA (tarlatamab-dlle): Amgen 9.2.1. Product Description 9.2.2. Regulatory milestones 9.2.3. Other developmental activities 9.2.4. Clinical development 9.2.5. Safety and efficacy List to be continued in the report 10. Emerging Therapies 10.1. Key Competitors 10.2. Peluntamig (PT217): Phanes Therapeutics 10.2.1. Product Description 10.2.2. Other developmental activities 10.2.3. Clinical development 10.2.4. Safety and efficacy 10.3. MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo 10.3.1. Product Description 10.3.2. Other developmental activities 10.3.3. Clinical development 10.3.4. Safety and efficacy List to be continued in the report 11. Delta-like Ligand 3 Targeted Therapies: Seven Major Market Analysis 11.1. Key Findings 11.2. Market Outlook 11.3. Conjoint Analysis 11.4. Key Market Forecast Assumptions 11.4.1. Cost Assumptions and Rebates 11.4.2. Pricing Trends 11.4.3. Analogue Assessment 11.4.4. Launch Year and Therapy Uptakes 11.5. Total Market Sizes of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in the 7MM 11.6. The United States Market Size 11.6.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in the United States 11.6.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indication in the United States 11.6.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in the United States 11.7. EU4 and the UK 11.7.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in EU4 and the UK 11.7.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in EU4 and the UK 11.7.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in EU4 and the UK 11.8. Japan 11.8.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies Inhibitors in Japan 11.8.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in Japan 11.8.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in Japan 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Market Access and Reimbursement 16. Appendix 16.1. Bibliography 16.2. Report Methodology 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports Small Cell Lung Cancer Market Small Cell Lung Cancer Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-06-2025
- Business
- Yahoo
Amgen Announces Significant Survival Benefit for Lung Cancer Drug IMDELLTRA in Phase 3 Trial
Amgen Inc. (NASDAQ:AMGN) is one of the 11 most profitable NASDAQ stocks to buy now. On June 2, Amgen announced new interim results from the global Phase 3 DeLLphi-304 trial for its drug IMDELLTRA (tarlatamab-dlle). The data were presented at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine. It showed that IMDELLTRA reduced the risk of death by 40% and extended median overall survival by over 5 months compared to standard-of-care/SOC chemotherapy in patients with small cell lung cancer/SCLC who had progressed on or after one line of platinum-based chemotherapy. IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen. A pharmacist filling a prescription for a complex drug developed by the company. It binds to DLL3, which is a protein expressed on the surface of SCLC cells in ~85-96% of patients but minimally on healthy cells, and CD3 on T-cells. This dual binding activates T-cells to specifically target and kill DLL3-expressing SCLC cells. The DeLLphi-304 trial is a global Phase 3, randomized, controlled, and open-label clinical study. It enrolled 509 patients. The results support the potential conversion of IMDELLTRA's accelerated FDA approval, which was granted last year based on tumor response rates, into a full approval. Amgen Inc. (NASDAQ:AMGN) discovers, develops, and manufactures human therapeutics globally. While we acknowledge the potential of AMGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
03-06-2025
- Business
- Yahoo
IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS
Breakthrough Second-Line Treatment Demonstrated Survival Advantage over Standard-of-Care Chemotherapy Late-Breaking Data Presented at ASCO 2025 and Simultaneously Published in The New England Journal of Medicine THOUSAND OAKS, Calif., June 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new interim results from the global Phase 3 DeLLphi-304 trial showing IMDELLTRA® (tarlatamab-dlle) reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard-of-care (SOC) chemotherapy in patients with small cell lung cancer (SCLC) who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs 8.3 months; hazard ratio [HR], 0.60; 95% confidence interval [CI]: 0.47, 0.77; P < 0.001). The results will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (LBA8008) and have been published in The New England Journal of Medicine. "Small cell lung cancer is an extraordinarily aggressive and difficult-to-treat disease, and those living with SCLC often experience limited benefit with first line treatment," said Jay Bradner, M.D., executive vice president, Research and Development, at Amgen. "These data underscore IMDELLTRA's potential to transform patient outcomes and the small cell lung cancer treatment paradigm." At the planned interim analysis, DeLLphi-304 met its primary OS endpoint and key secondary progression-free survival (PFS) endpoint. Additionally, IMDELLTRA significantly improved patient-reported outcomes (PRO) for cancer-related symptoms of dyspnea and cough compared to the control arm. "The data from DeLLphi-304 mark a major milestone for people with relapsed small cell lung cancer. Tarlatamab is associated with significant improvements in both overall and progression-free survival over standard chemotherapy in patients with recurrent or progressive disease," said Charles Rudin, M.D., Ph.D., deputy director, Memorial Sloan Kettering Cancer Center. "This study also provides confirmatory data on management of potential toxicities associated with bispecific T-cell engager therapies in a large patient cohort, which is crucial to continuing to improve the experience of patients treated with these medicines." At a median follow-up of 11.2 months for IMDELLTRA and 11.7 months for the control arm, data from the global Phase 3 DeLLphi-304 clinical trial showed a median OS of 13.6 months with IMDELLTRA compared to 8.3 months with local SOC chemotherapy (HR, 0.60; 95% CI: 0.47, 0.77; P < 0.001). Median PFS was statistically significantly improved for IMDELLTRA compared to local SOC chemotherapy (median PFS: 4.2 vs 3.7 months; HR, 0.71; 95% CI: 0.59, 0.86; P < 0.001). The safety profile for IMDELLTRA in DeLLphi-304 was consistent with its known profile. In DeLLphi-304, lower rates of grade 3 or higher treatment-related adverse events (TRAEs) occurred with IMDELLTRA versus the control arm (27% vs 62%) and discontinuations due to TRAEs were lower with IMDELLTRA compared to the control arm (3% vs 6%). The most common grade 3 or greater TRAEs were neutropenia (4%) and lymphopenia (4%) with IMDELLTRA and anemia (28%) and neutropenia (22%) with local SOC chemotherapy. Cytokine release syndrome (CRS) with IMDELLTRA primarily occurred after receipt of one of the first two doses and was primarily low grade (42% Grade 1; 13% Grade 2; 1% Grade 3) and manageable. No Grade 4 or Grade 5 CRS events were reported. CRS profiles following the first two doses of IMDELLTRA, including incidence, severity, outcome, time to intervention and time to resolution, were similar among patients who were monitored for 6 to 8 hours (n=43) and those who were monitored for 48 hours (n=209). DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA as a treatment for patients living with SCLC who progressed on or after a single line of platinum-based chemotherapy.1 Five hundred and nine patients were randomized to receive either IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan; lurbinectedin in the U.S., Canada, Australia, Singapore, Korea; and amrubicin in Japan).1,2 The primary outcome measure of the trial is OS.1 Key secondary outcome measures include PFS and PROs including disease-related symptoms, physical function and quality of life.1 DeLLphi-304 is intended to serve as the confirmatory trial for IMDELLTRA's accelerated approval for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. About IMDELLTRA® (tarlatamab-dlle)IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.3,4 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.5,6 IMDELLTRA® (tarlatamab-dlle) U.S. IndicationIMDELLTRA® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). About Small Cell Lung Cancer (SCLC)SCLC is one of the most aggressive and devastating solid tumor malignancies, with a 5-10% five-year relative survival rate across all stages combined.7 SCLC comprises about 15% of the more than 2.4 million patients diagnosed with lung cancer worldwide each year.8-10 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.9 About Tarlatamab Clinical TrialsAmgen's robust tarlatamab development program includes the DeLLphi clinical trials, which evaluate tarlatamab as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment. Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard-of-care therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with standard-of-care chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab versus durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; and DeLLphi-312, a Phase 3 study evaluating tarlatamab as an induction and maintenance therapy in first-line treatment of ES-SCLC in combination with carboplatin, etoposide, and durvalumab.11 For more information, please visit About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads. IMDELLTRA® (tarlatamab-dlle) Important Safety Information (USPI) WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA®. Initiate treatment with IMDELLTRA® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA®. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA® until ICANS resolves or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): IMDELLTRA® can cause CRS including serious or life-threatening reactions. In the pooled safety population, CRS occurred in 55% of patients who received IMDELLTRA®, including 34% Grade 1, 19% Grade 2, 1.1% Grade 3 and 0.5% Grade 4. Recurrent CRS occurred in 24% of patients, including 18% Grade 1 and 6% Grade events (43%) of CRS occurred after the first dose, with 29% of patients experiencing any grade CRS after the second dose and 9% of patients experiencing CRS following the third dose or later. Following the Day 1, Day 8, and Day 15 infusions, 16%, 4.3% and 2.1% of patients experienced ≥ Grade 2 CRS, respectively. The median time to onset of all grade CRS from most recent dose of IMDELLTRA® was 13.5 hours (range: 1 to 268 hours). The median time to onset of ≥ Grade 2 CRS from most recent dose of IMDELLTRA® was 14.6 hours (range: 2 to 566 hours).Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).Administer IMDELLTRA® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 IMDELLTRA® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA® in an appropriate health care facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA®.Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA®. At the first sign of CRS, immediately discontinue IMDELLTRA® infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA® based on severity. Counsel patients to seek medical attention should signs or symptoms of CRS occur. Neurologic Toxicity, Including ICANS: IMDELLTRA® can cause serious or life-threatening neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity, including ICANS, occurred in 47% of patients who received IMDELLTRA®, including 10% Grade 3. The most frequent neurologic toxicities were headache (14%), peripheral neuropathy (7%), dizziness (7%), insomnia (6%), muscular weakness (3.7%), delirium (2.1%), syncope (1.6%), and neurotoxicity (1.1%).ICANS occurred in 9% of IMDELLTRA®-treated patients. Recurrent ICANS occurred in 1.6% of patients. Most patients experienced ICANS following Cycle 2 Day 1 (24%). Following Day 1, Day 8, and Day 15 infusions, 0.5%, 0.5% and 3.7% of patients experienced ≥ Grade 2 ICANS, respectively. The median time to onset of ICANS from the first dose of IMDELLTRATM was 29.5 days (range: 1 to 154 days). ICANS can occur several weeks following administration of IMDELLTRATM. The median time to resolution of ICANS was 33 days (range: 1 to 93 days).The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and receiving IMDELLTRA® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, in the event of any neurologic symptoms until they monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of ICANS, immediately evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA® or permanently discontinue based on severity. Cytopenias: IMDELLTRA® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, decreased neutrophils occurred in 12% including 6% Grade 3 or 4 of IMDELLTRA®-treated patients. The median time to onset for Grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213). Decreased platelets occurred in 33% including 3.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 50 days (range: 3 to 420). Decreased hemoglobin occurred in 58% including 5% Grade 3 or 4. Febrile neutropenia occurred in 0.5% of patients treated with IMDELLTRA®.Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with IMDELLTRA®, before each dose, and as clinically indicated. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA®. Infections: IMDELLTRA® can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections, including opportunistic infections, occurred in 41% of patients who received IMDELLTRA®. Grade 3 or 4 infections occurred in 13% of patients. The most frequent infections were COVID-19 (9%, majority during the COVID-19 pandemic), urinary tract infection (10%), pneumonia (9%), respiratory tract infection (3.2%), and candida infection (3.2%).Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA® based on severity. Hepatotoxicity: IMDELLTRA® can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 42%, with Grade 3 or 4 ALT elevation occurring in 2.1%. Elevated AST occurred in 44% of patients, with Grade 3 or 4 AST elevation occurring in 3.2%. Elevated bilirubin occurred in 15% of patients; Grade 3 or 4 total bilirubin elevations occurred in 1.6% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA®, before each dose, and as clinically indicated. Withhold IMDELLTRA® or permanently discontinue based on severity. Hypersensitivity: IMDELLTRA® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA® based on severity. Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA® and for 2 months after the last dose. ADVERSE REACTIONS The most common (> 20%) adverse reactions were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%) and nausea (22%). The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (57%), decreased sodium (16%), increased uric acid (10%), decreased total neutrophils (6%), decreased hemoglobin (5%), increased activated partial thromboplastin time (5%), decreased potassium (5%), increased aspartate aminotransferase (3.2%), decreased white blood cells (3.8%), decreased platelets (3.2%), and increased alanine aminotransferase (2.1%). Serious adverse reactions occurred in 58% of patients. Serious adverse reactions in > 3% of patients included CRS (24%), pneumonia (6%), pyrexia (3.7%), and hyponatremia (3.6%). Fatal adverse reactions occurred in 2.7% of patients including pneumonia (0.5%), aspiration (0.5%), pulmonary embolism (0.5%), respiratory acidosis (0.5%), and respiratory failure (0.5%). DOSAGE AND ADMINISTRATION: Important Dosing Information Administer IMDELLTRA® as an intravenous infusion over one hour. Administer IMDELLTRA® according to the step-up dosing schedule in the IMDELLTRA® PI (Table 1) to reduce the incidence and severity of CRS. For Cycle 1, administer recommended concomitant medications before and after Cycle 1 IMDELLTRA® infusions to reduce the risk of CRS reactions as described in the PI (Table 3). IMDELLTRA® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS. Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA® infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Prior to administration of IMDELLTRA® evaluate complete blood count, liver enzymes, and bilirubin before each dose, and as clinically indicated. Ensure patients are well hydrated prior to administration of IMDELLTRA®. Please see IMDELLTRA® full Prescribing Information, including BOXED WARNINGS. Amgen Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media)Justin Claeys, 805-313-9775 (investors) REFERENCES: DeLLphi-304 Clinical Trial Listing. Available at: Accessed March 24, 2025. Paz-Ares, et al. JCO. 41, TPS8611-TPS8611(2023). DOI:10.1200/JCO.2023.41.16_suppl.TPS8611 Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a Half-Life Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High Potency and Sensitivity in Preclinical Models of Small-Cell Lung Cancer. Clin Cancer Res. 2021;27:1526-1537. Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther. 2009;11:22-30. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023;389:2063-2075. Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237-243. PDQ® Adult Treatment Editorial Board. PDQ Small Cell Lung Cancer Treatment. Bethesda, MD: National Cancer Institute. Updated June 27, 2024. Available at: Accessed March 25, 2025. World Health Organization. Lung. 2022. Available at: Accessed on March 24, 2025. Oronsky B, Abrouk N, Caroen S, et al. A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC). J Cancer. 2022;13:2945-2953. Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14:549-561. Clinical Trials. Tarlatamab Clinical Trial Listings. Accessed March 25, 2025. View original content to download multimedia: SOURCE Amgen
Yahoo
18-04-2025
- Health
- Yahoo
Weekly Recap: 15 Health Press Releases You Need to See
A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including the first use of Johnson & Johnson's robotic surgical system and a staggering global statistic on pediatric antimicrobial resistance. NEW YORK, April 18, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical SystemOTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach. Novo Nordisk warns consumers about counterfeit Ozempic® (semaglutide) injection 1 mg in the USNovo Nordisk has become aware of several hundred units of Ozempic® (semaglutide) injection 1 mg distributed outside the Novo Nordisk authorized supply chain in the US. The US Food and Drug Administration (FDA) has also updated its website with information about these counterfeit versions of Ozempic. IMDELLTRA® Demonstrated Superior Overall Survival in Small Cell Lung CancerIMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. Jay Bradner, M.D., executive vice president, Research and Development, at Amgen, commented on the "overwhelming clinical benefit" stating the results "affirm IMDELLTRA as standard of care." The Elizabeth Taylor AIDS Foundation Issues Emergency Grant Cycle to Address Forthcoming Gap FundingProviding financial resources to organizations in need, the initiative will be aimed at ensuring that critical, wrap-around health services for HIV treatment & prevention and programs focused on Transgender communities can continue to operate into the near future. Over 3 million children died from AMR-related infections in 2022, major study showsThe study data found that in 2022 alone, more than 752,000 children in Southeast Asia and 659,000 children in Africa died of antimicrobial resistance (AMR)-related infections. Globally, of the more than 3 million children's deaths, 2 million were associated with the use of Watch and Reserve antibiotics. SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNAPreliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine. Crunch Fitness Announces Strategic Investment from Leonard Green & PartnersUnder the terms of the agreement, LGP will acquire a majority interest in Crunch Fitness from TPG Growth, the middle market and growth equity platform of global alternative asset management firm TPG, and Crunch's minority shareholders. Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial"As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world," said David A. Ricks, Lilly chair and CEO. Hyundai Hope on Wheels Commemorates 27th Anniversary with $27 Million Donation to Pediatric Cancer Research"Hyundai Hope on Wheels has been a driving force in pediatric cancer research for nearly three decades, and we are proud to expand its reach beyond the U.S. to support children throughout North America," said Randy Parker, president and CEO, Hyundai Motor North America. Norgine strengthens rare disease portfolio with acquisition of TheraviaThe acquisition of Theravia from Mérieux Equity Partners represents a meaningful step forward in Norgine's strategy for sustainable growth, adding a complementary portfolio of rare disease medicines. New Docuseries People Worth Caring About Shines a Light on Ohio's Long-Term Care WorkersLong-term care workers play a critical role in the well-being of hundreds of thousands of Ohio residents, yet their stories often go untold. People Worth Caring About seeks to change that by showcasing the personal and professional journeys of these caregivers, illuminating the challenges they face and the deep fulfillment they find in their work. Illumina and Tempus partner to drive the future of precision medicine through genomic AI innovationThe collaboration will combine leading Illumina AI technologies with Tempus's comprehensive multimodal data platform to train genomic algorithms and ultimately accelerate clinical adoption of molecular testing for patients. Recently Discovered Immune Cell Type Is Key to Understanding Food AllergiesA new study led by researchers at NYU Langone Health has revealed that a special group of cells in the intestines tamp down the immune responses caused by exposure to food proteins. Called "tolerogenic dendritic cells," these cells enable food to pass through the body without triggering an immune reaction, unless they malfunction to cause allergies. Optellum Announces Agreement with Bristol Myers Squibb to Leverage AI to Boost Early Lung Cancer DiagnosisOptellum's Virtual Nodule Clinic (VNC) is the first FDA-cleared AI-powered decision support tool for early-stage lung cancer, reimbursed by CMS and implemented by leading health systems. New Research to Examine the Impact of Service Dogs On Post Traumatic Growth in Veterans with PTSD"Most research on PTSD has focused on the negative impacts of trauma exposure, but more recently, there has been growing interest in the potential for positive shifts after traumatic experiences," said Dr. Kevin Morris, the Principal Investigator of this research project. "We hypothesize that pairing veterans with PTSD and psychiatric service dogs will help promote this positive growth, which may include feelings of hope, agency, and a sense of purpose or meaning in life." For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at View original content to download multimedia: SOURCE PR Newswire Sign in to access your portfolio
