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Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)
The triple-negative breast cancer market is expected to grow due to rising incidence rates, increasing awareness, advancements in targeted therapies, ongoing clinical trials, improved diagnostics, and greater investment in research and development. Along with these, the launch of emerging therapies such as DATROWAY, PADCEV, BNT327/ PM8002, and others will fuel the TNBC market growth. LAS VEGAS, July 29, 2025 /PRNewswire/ — DelveInsight's Triple-Negative Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, triple-negative breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Triple-Negative Breast Cancer Market Report According to DelveInsight's analysis, the market size for triple-negative breast cancer was found to be USD 4.5 billion in the 7MM in 2024. The United States accounted for the highest market size of TNBC, approximately 69% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. As per the estimates, among the current treatment options, KEYTRUDA (pembrolizumab) and chemotherapy held the largest TNBC treatment market share, generating approximately USD 2 billion in revenue in 2024 across the 7MM. In 2024, 7MM recorded approximately 104K new TNBC cases. With a projected CAGR of 0.7%, the number of cases is expected to gradually rise, leading to a higher disease burden by 2034. Leading triple-negative breast cancer companies developing emerging therapies, such as AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, and others, are developing new TNBC treatment drugs that can be available in the triple-negative breast cancer market in the coming years. The promising triple-negative breast cancer therapies in the pipeline include DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), and others. Discover the TNBC new treatment @ New Treatments for TNBC Triple-Negative Breast Cancer Market Dynamics The triple-negative breast cancer market dynamics are expected to change in the coming years. Combining chemotherapy, immunotherapy, and targeted therapies, such as TALZENNA and TRODELVY, offers enhanced disease control and expands treatment options for advanced-stage TNBC patients, while innovations in immune checkpoint inhibitors, therapeutic vaccines, and ongoing research into personalized approaches are transforming long-term management by boosting immune response, improving survival rates, and addressing the need for more effective, tailored solutions beyond first-line therapy As potential therapies are being investigated for the treatment of triple-negative breast cancer, it is safe to predict that the treatment space will significantly impact the triple-negative breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the triple-negative breast cancer market in the 7MM. However, several factors may impede the growth of the triple-negative breast cancer market. TNBC is the most difficult breast cancer subtype to manage due to its aggressive nature, lack of targeted treatment options, and high rates of chemotherapy resistance, which contribute to frequent relapse, reduced treatment efficacy, and limited long-term remission, even when diagnosed early; this underscores the urgent need for innovative, effective therapies that not only improve outcomes and prevent disease progression but also minimize the significant side effects of current aggressive treatments like chemotherapy and immunotherapy, which severely impact patient quality of life. Moreover, triple-negative breast cancer treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the triple-negative breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the triple-negative breast cancer market growth. Triple-Negative Breast Cancer Treatment Market Triple-negative breast cancer lacks expression of hormone receptors and HER2, rendering it unresponsive to endocrine and HER2-targeted therapies. Consequently, systemic chemotherapy has long been the mainstay of treatment, especially in metastatic settings. Management typically starts with neoadjuvant or adjuvant chemotherapy, progressing to first-line treatments in advanced stages. If the disease advances or shows inadequate response, additional lines of therapy are introduced. Immunotherapies, particularly PD-1/PD-L1 inhibitors, are increasingly being utilized in metastatic TNBC to boost the body's immune defense against cancer cells. In early-stage TNBC, the PD-1 inhibitor KEYTRUDA (pembrolizumab) has become a standard part of treatment. It is administered with neoadjuvant chemotherapy and then continued as adjuvant monotherapy. In PD-L1-positive patients (CPS ≥10), it is also used alongside chemotherapy for locally recurrent or metastatic disease. Targeted therapies are making headway as well, particularly for patients with BRCA mutations. In such cases, PARP inhibitors like LYNPARZA (olaparib) and TALZENNA (talazoparib) target defective DNA repair pathways. TRODELVY (sacituzumab govitecan), an antibody-drug conjugate (ADC) targeting TROP-2, is approved for relapsed or treatment-resistant metastatic TNBC. Although TECENTRIQ (atezolizumab) was withdrawn from the U.S. market after failing confirmatory trials, it is still available in Europe and Japan. Taxane-based chemotherapy continues to be a cornerstone of TNBC treatment and is often combined with immune checkpoint inhibitors in PD-L1-positive cases. Platinum-based chemotherapy, though occasionally used, has shown mixed results due to concerns over toxicity and limited benefit. Despite therapeutic progress, TNBC remains a particularly aggressive subtype, underscoring the urgent need for continued innovation. Overall, current treatments frequently fall short of achieving lasting disease control, highlighting the pressing demand for novel therapies that can improve long-term outcomes and survival for TNBC patients. To know more about FDA-approved drugs for TNBC, visit @ Approved TNBC Treatment Triple-Negative Breast Cancer Pipeline Therapies and Key Companies Some of the drugs in the pipeline include DATROWAY [(Datopotamab Deruxtecan), AstraZeneca and Daiichi Sankyo], IMFINZI [(Durvalumab), AstraZeneca], PADCEV [(Enfortumab vedotin), Astellas Pharma and Pfizer], Tilarginine [(L-NMMA), Galera Therapeutics], and others. Datopotamab deruxtecan (Dato-DXd), also known as DATROWAY, is an experimental antibody-drug conjugate (ADC) being evaluated for the treatment of triple-negative breast cancer, both as a standalone therapy and in combination with IMFINZI (durvalumab). The therapy is aimed at high-risk TNBC patients, including those who are PD-L1-positive. Results from pivotal Phase III trials are expected in 2025, with more comprehensive findings anticipated by 2026, potentially influencing future treatment approaches for TNBC. Currently in Phase III development for TNBC, Dato-DXd is part of a global collaboration between AstraZeneca and Daiichi Sankyo, initiated in July 2020. Under this partnership, Daiichi Sankyo retains exclusive rights in Japan and oversees manufacturing and supply, while both companies are co-developing the drug across several cancer types globally. Tilarginine (L-NMMA), a broad nitric oxide synthase (NOS) inhibitor, is under Phase II investigation for metaplastic breast cancer (MpBC) in combination with alpelisib and nab-paclitaxel in HER2-negative metastatic or locally advanced settings. It is also being explored with a taxane in Phase II trials for patients with metastatic or locally advanced TNBC. In December 2024, Galera Therapeutics acquired Nova Pharmaceuticals. IMFINZI (durvalumab), an FDA-approved PD-L1 inhibitor developed by AstraZeneca for other cancers, works by blocking PD-L1 to enhance immune system recognition and destruction of tumor cells. It is currently undergoing Phase I/II studies in combination with paclitaxel and other novel therapies as a first-line option for metastatic TNBC (mTNBC), with key data expected by late 2025. Notably, the BEGONIA trial (October 2023) reported durable and significant tumor responses from the combination of datopotamab deruxtecan and IMFINZI when used as a first-line treatment for patients with mTNBC, along with a favorable safety profile. The anticipated launch of these emerging therapies are poised to transform the triple-negative breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the triple-negative breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials Recent Developments in the Triple-Negative Breast Cancer Market In May 2025, Gilead Sciences, Inc. reported that TRODELVY (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) lowered the risk of disease progression or death by 35% (hazard ratio: 0.65) compared to the standard treatment of Keytruda plus chemotherapy as a first-line therapy for patients with PD-L1–positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). In May 2025, Gilead Sciences, Inc. reported positive topline results from the Phase 3 ASCENT-03 trial evaluating TRODELVY (sacituzumab govitecan-hziy). The study achieved its primary goal by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for PD-1/PD-L1 inhibitors, either due to being PD-L1 negative or otherwise unsuitable for immunotherapy. In December 2024, Galera Therapeutics completed the acquisition of Nova Pharmaceuticals. Triple-Negative Breast Cancer Overview Triple-negative breast cancer is a particularly aggressive and diverse form of breast cancer that lacks expression of estrogen receptors (ER), progesterone receptors (PR), and HER2. It accounts for a substantial share of breast cancer cases and is associated with fast disease progression, high chances of recurrence, and unfavorable outcomes. TNBC tends to occur more frequently in younger women, individuals of African American descent, and those with BRCA1 gene mutations. The risk factors for TNBC are divided into two categories: non-modifiable factors, such as age, gender, genetic mutations, family history, and breast density, and modifiable ones, which include obesity, exposure to certain chemicals, and specific drug use. Due to its aggressive behavior and absence of hormone receptors, TNBC is particularly difficult to treat, highlighting the need for continuous research to enhance therapeutic approaches and patient survival. Diagnosis typically involves imaging tools like mammography, ultrasound, and MRI, followed by tissue sampling techniques including core needle biopsy, fine needle aspiration, or surgical biopsy. TNBC tumors are often high-grade and poorly differentiated, and the disease is staged using the TNM system, which evaluates tumor size, lymph node involvement, and the extent of metastasis. Triple-Negative Breast Cancer Epidemiology Segmentation The triple-negative breast cancer epidemiology section provides insights into the historical and current triple-negative breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The triple-negative breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Breast Cancer Total Incident Cases of TNBC Gene Mutation-specific Incident Cases of TNBC Stage-specific Incident Cases of TNBC Age-specific Incident Cases of TNBC Line-wise Treated Incident Cases of TNBC Triple-Negative Breast Cancer Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Triple-Negative Breast Cancer Market CAGR 4.7 % Triple-Negative Breast Cancer Market Size in 2024 USD 4.5 Billion Key Triple-Negative Breast Cancer Companies AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, Merck, Gilead Sciences, Roche, Genentech, and others Key Triple-Negative Breast Cancer Therapies DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), KEYTRUDA, TRODELVY, TALZENNA, LYNPARZA, TECENTRIQ, and others Scope of the Triple-Negative Breast Cancer Market Report Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Triple-Negative Breast Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Triple-Negative Breast Cancer Market Access and Reimbursement Download the report to understand which factors are driving triple-negative breast cancer market trends @ Triple-Negative Breast Cancer Market Forecast Table of Contents 1 Key Insights 2 Report Introduction 3 TNBC Market Overview at a Glance 3.1 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2020 3.2 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2034 4 Executive Summary 5 Key Events 6 Disease Background and Overview 6.1 Introduction 6.2 Various Subtypes of Breast Cancer Based on Immunohistochemical Expression 6.3 TNBC Overview 6.3.1 Intrinsic Molecular Subtypes in TNBC 6.3.2 Characteristics of Tumor Microenvironment in TNBC 6.3.3 Potential Risk Factors 6.3.4 Clinical Presentation 6.3.5 Characterization of HER2-low Breast Cancers 6.4 Diagnosis 6.4.1 Staging 6.4.2 Grading 6.4.3 Clinical Prognostic Stage 6.4.4 Pathological Prognostic Stage 6.4.5 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer 6.4.6 Recommendations for HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline Update 6.4.7 Diagnostic Algorithm 6.5 Treatment and Management 6.5.1 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer 6.5.2 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Early Breast Cancer 6.5.3 ESMO Clinical Practice Guideline for the Diagnosis, Staging, and Treatment of Patients with Metastatic Breast Cancer 6.5.4 Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for Breast Cancer – 2022 Update 6.5.5 Treatment Algorithm 7 Epidemiology and Market Forecast Methodology 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.2.1 Incident Cases of Breast Cancer 8.2.2 Incident Cases of TNBC 8.2.3 Gene Mutation-specific Incident Cases of TNBC 8.2.4 Stage-specific Incident Cases of TNBC 8.2.5 Age-specific Incident Cases of TNBC 8.3 Total Incident Cases of Breast Cancer in the 7MM 8.4 Total Incident Cases of TNBC in the 7MM 8.5 The United States 8.6 EU4 and the UK 8.7 Japan 9 Patient Journey 10 Marketed Therapies 10.1 Key Cross Competition 10.2 KEYTRUDA (pembrolizumab): Merck 10.2.1 Product Description 10.2.2 Regulatory Milestone 10.2.3 Other Developmental Activities 10.2.4 Clinical Trials Information 10.2.5 Safety and Efficacy 10.3 TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences 10.4 TALZENNA (talazoparib): Pfizer 10.5 LYNPARZA (olaparib): AstraZeneca/Merck 10.6 TECENTRIQ (atezolizumab): Roche/Genentech To be continued in the report… 11 Emerging Drug Profiles 11.1 Key Cross Competition of Emerging Drugs 11.2 DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo 11.2.1 Drug Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analysts' View 11.3 PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer 11.4 Tilarginine: Galera Therapeutics 11.5 BNT327/PM8002: BioNTech 11.6 IMFINZI (Durvalumab): AstraZeneca To be continued in the report… 12 TNBC: Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Attribute Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptake 12.5 Total Market Size of TNBC in the 7MM 12.6 Market Size of TNBC by Therapies in the 7MM 12.7 Market Size of TNBC in the United States 12.8 Market Size of TNBC in EU4 and the UK 12.9 Market Size of TNBC in Japan 13 Key Opinion Leaders' Views 14 Unmet Needs 15 SWOT Analysis 16 Market Access and Reimbursement 16.1 The United States 16.2 In EU4 and the UK 16.3 Japan 17 Acronyms and Abbreviations 18 Bibliography 19 Report Methodology Related Reports PD-L1 Inhibitors Market PD-L1 Inhibitors Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PD-L1 inhibitors companies including EQRX, CSTONE PHARMACEUTICALS, PFIZER, NOVARTIS, ARCUS BIOSCIENCES, AGENUS, TRACON PHARMACEUTICALS, SHANGHAI HENLIUS BIOTECH, INCYTE CORPORATION, among others. PARP Inhibitors Market PARP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PARP inhibitors companies including AstraZeneca, Merck, Janssen, Pfizer, Astellas, Pharma& Schweiz, AtlasMedx, AbbVie, GlaxoSmithKline, Pfizer, BeiGene, Allarity Therapeutics, among others. Triple-Negative Breast Cancer Pipeline Triple-Negative Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TNBC companies, including G1 Therapeutics, Inc., Gilead Sciences, Biotheus Inc., GlaxoSmithKline, AstraZeneca, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company, Merck, SynDevRx, Inc., Treadwell Therapeutics, AstraZeneca, Novartis Pharmaceuticals, NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., Phoenix Molecular Designs, Pure Biologics S.A., Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Tubulis GmbH, Hinova Pharmaceuticals, Primevax, ARCE Therapeutics, HC Biopharma, Casinvent, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. 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 [email protected] + Logo: View original content:
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Triple-Negative Breast Cancer Market Gearing Up for Impressive Growth at a CAGR of 4.7% During the Forecast Period (2025-2034)
The triple-negative breast cancer market is expected to grow due to rising incidence rates, increasing awareness, advancements in targeted therapies, ongoing clinical trials, improved diagnostics, and greater investment in research and development. Along with these, the launch of emerging therapies such as DATROWAY, PADCEV, BNT327/ PM8002, and others will fuel the TNBC market growth. LAS VEGAS, July 29, 2025 /PRNewswire/ -- DelveInsight's Triple-Negative Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, triple-negative breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Triple-Negative Breast Cancer Market Report According to DelveInsight's analysis, the market size for triple-negative breast cancer was found to be USD 4.5 billion in the 7MM in 2024. The United States accounted for the highest market size of TNBC, approximately 69% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. As per the estimates, among the current treatment options, KEYTRUDA (pembrolizumab) and chemotherapy held the largest TNBC treatment market share, generating approximately USD 2 billion in revenue in 2024 across the 7MM. In 2024, 7MM recorded approximately 104K new TNBC cases. With a projected CAGR of 0.7%, the number of cases is expected to gradually rise, leading to a higher disease burden by 2034. Leading triple-negative breast cancer companies developing emerging therapies, such as AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, and others, are developing new TNBC treatment drugs that can be available in the triple-negative breast cancer market in the coming years. The promising triple-negative breast cancer therapies in the pipeline include DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), and others. Discover the TNBC new treatment @ New Treatments for TNBC Triple-Negative Breast Cancer Market Dynamics The triple-negative breast cancer market dynamics are expected to change in the coming years. Combining chemotherapy, immunotherapy, and targeted therapies, such as TALZENNA and TRODELVY, offers enhanced disease control and expands treatment options for advanced-stage TNBC patients, while innovations in immune checkpoint inhibitors, therapeutic vaccines, and ongoing research into personalized approaches are transforming long-term management by boosting immune response, improving survival rates, and addressing the need for more effective, tailored solutions beyond first-line therapy As potential therapies are being investigated for the treatment of triple-negative breast cancer, it is safe to predict that the treatment space will significantly impact the triple-negative breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the triple-negative breast cancer market in the 7MM. However, several factors may impede the growth of the triple-negative breast cancer market. TNBC is the most difficult breast cancer subtype to manage due to its aggressive nature, lack of targeted treatment options, and high rates of chemotherapy resistance, which contribute to frequent relapse, reduced treatment efficacy, and limited long-term remission, even when diagnosed early; this underscores the urgent need for innovative, effective therapies that not only improve outcomes and prevent disease progression but also minimize the significant side effects of current aggressive treatments like chemotherapy and immunotherapy, which severely impact patient quality of life. Moreover, triple-negative breast cancer treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the triple-negative breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the triple-negative breast cancer market growth. Triple-Negative Breast Cancer Treatment Market Triple-negative breast cancer lacks expression of hormone receptors and HER2, rendering it unresponsive to endocrine and HER2-targeted therapies. Consequently, systemic chemotherapy has long been the mainstay of treatment, especially in metastatic settings. Management typically starts with neoadjuvant or adjuvant chemotherapy, progressing to first-line treatments in advanced stages. If the disease advances or shows inadequate response, additional lines of therapy are introduced. Immunotherapies, particularly PD-1/PD-L1 inhibitors, are increasingly being utilized in metastatic TNBC to boost the body's immune defense against cancer cells. In early-stage TNBC, the PD-1 inhibitor KEYTRUDA (pembrolizumab) has become a standard part of treatment. It is administered with neoadjuvant chemotherapy and then continued as adjuvant monotherapy. In PD-L1-positive patients (CPS ≥10), it is also used alongside chemotherapy for locally recurrent or metastatic disease. Targeted therapies are making headway as well, particularly for patients with BRCA mutations. In such cases, PARP inhibitors like LYNPARZA (olaparib) and TALZENNA (talazoparib) target defective DNA repair pathways. TRODELVY (sacituzumab govitecan), an antibody-drug conjugate (ADC) targeting TROP-2, is approved for relapsed or treatment-resistant metastatic TNBC. Although TECENTRIQ (atezolizumab) was withdrawn from the U.S. market after failing confirmatory trials, it is still available in Europe and Japan. Taxane-based chemotherapy continues to be a cornerstone of TNBC treatment and is often combined with immune checkpoint inhibitors in PD-L1-positive cases. Platinum-based chemotherapy, though occasionally used, has shown mixed results due to concerns over toxicity and limited benefit. Despite therapeutic progress, TNBC remains a particularly aggressive subtype, underscoring the urgent need for continued innovation. Overall, current treatments frequently fall short of achieving lasting disease control, highlighting the pressing demand for novel therapies that can improve long-term outcomes and survival for TNBC patients. To know more about FDA-approved drugs for TNBC, visit @ Approved TNBC Treatment Triple-Negative Breast Cancer Pipeline Therapies and Key Companies Some of the drugs in the pipeline include DATROWAY [(Datopotamab Deruxtecan), AstraZeneca and Daiichi Sankyo], IMFINZI [(Durvalumab), AstraZeneca], PADCEV [(Enfortumab vedotin), Astellas Pharma and Pfizer], Tilarginine [(L-NMMA), Galera Therapeutics], and others. Datopotamab deruxtecan (Dato-DXd), also known as DATROWAY, is an experimental antibody-drug conjugate (ADC) being evaluated for the treatment of triple-negative breast cancer, both as a standalone therapy and in combination with IMFINZI (durvalumab). The therapy is aimed at high-risk TNBC patients, including those who are PD-L1-positive. Results from pivotal Phase III trials are expected in 2025, with more comprehensive findings anticipated by 2026, potentially influencing future treatment approaches for TNBC. Currently in Phase III development for TNBC, Dato-DXd is part of a global collaboration between AstraZeneca and Daiichi Sankyo, initiated in July 2020. Under this partnership, Daiichi Sankyo retains exclusive rights in Japan and oversees manufacturing and supply, while both companies are co-developing the drug across several cancer types globally. Tilarginine (L-NMMA), a broad nitric oxide synthase (NOS) inhibitor, is under Phase II investigation for metaplastic breast cancer (MpBC) in combination with alpelisib and nab-paclitaxel in HER2-negative metastatic or locally advanced settings. It is also being explored with a taxane in Phase II trials for patients with metastatic or locally advanced TNBC. In December 2024, Galera Therapeutics acquired Nova Pharmaceuticals. IMFINZI (durvalumab), an FDA-approved PD-L1 inhibitor developed by AstraZeneca for other cancers, works by blocking PD-L1 to enhance immune system recognition and destruction of tumor cells. It is currently undergoing Phase I/II studies in combination with paclitaxel and other novel therapies as a first-line option for metastatic TNBC (mTNBC), with key data expected by late 2025. Notably, the BEGONIA trial (October 2023) reported durable and significant tumor responses from the combination of datopotamab deruxtecan and IMFINZI when used as a first-line treatment for patients with mTNBC, along with a favorable safety profile. The anticipated launch of these emerging therapies are poised to transform the triple-negative breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the triple-negative breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about triple-negative breast cancer drugs in development @ Triple-Negative Breast Cancer Clinical Trials Recent Developments in the Triple-Negative Breast Cancer Market In May 2025, Gilead Sciences, Inc. reported that TRODELVY (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) lowered the risk of disease progression or death by 35% (hazard ratio: 0.65) compared to the standard treatment of Keytruda plus chemotherapy as a first-line therapy for patients with PD-L1–positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). In May 2025, Gilead Sciences, Inc. reported positive topline results from the Phase 3 ASCENT-03 trial evaluating TRODELVY (sacituzumab govitecan-hziy). The study achieved its primary goal by showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for PD-1/PD-L1 inhibitors, either due to being PD-L1 negative or otherwise unsuitable for immunotherapy. In December 2024, Galera Therapeutics completed the acquisition of Nova Pharmaceuticals. Triple-Negative Breast Cancer Overview Triple-negative breast cancer is a particularly aggressive and diverse form of breast cancer that lacks expression of estrogen receptors (ER), progesterone receptors (PR), and HER2. It accounts for a substantial share of breast cancer cases and is associated with fast disease progression, high chances of recurrence, and unfavorable outcomes. TNBC tends to occur more frequently in younger women, individuals of African American descent, and those with BRCA1 gene mutations. The risk factors for TNBC are divided into two categories: non-modifiable factors, such as age, gender, genetic mutations, family history, and breast density, and modifiable ones, which include obesity, exposure to certain chemicals, and specific drug use. Due to its aggressive behavior and absence of hormone receptors, TNBC is particularly difficult to treat, highlighting the need for continuous research to enhance therapeutic approaches and patient survival. Diagnosis typically involves imaging tools like mammography, ultrasound, and MRI, followed by tissue sampling techniques including core needle biopsy, fine needle aspiration, or surgical biopsy. TNBC tumors are often high-grade and poorly differentiated, and the disease is staged using the TNM system, which evaluates tumor size, lymph node involvement, and the extent of metastasis. Triple-Negative Breast Cancer Epidemiology Segmentation The triple-negative breast cancer epidemiology section provides insights into the historical and current triple-negative breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The triple-negative breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Breast Cancer Total Incident Cases of TNBC Gene Mutation-specific Incident Cases of TNBC Stage-specific Incident Cases of TNBC Age-specific Incident Cases of TNBC Line-wise Treated Incident Cases of TNBC Triple-Negative Breast Cancer Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Triple-Negative Breast Cancer Market CAGR 4.7 % Triple-Negative Breast Cancer Market Size in 2024 USD 4.5 Billion Key Triple-Negative Breast Cancer Companies AstraZeneca, Daiichi Sankyo, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, Merck, Gilead Sciences, Roche, Genentech, and others Key Triple-Negative Breast Cancer Therapies DATROWAY (Datopotamab Deruxtecan), PADCEV (Enfortumab vedotin), Tilarginine, BNT327/PM8002, IMFINZI (Durvalumab), KEYTRUDA, TRODELVY, TALZENNA, LYNPARZA, TECENTRIQ, and others Scope of the Triple-Negative Breast Cancer Market Report Therapeutic Assessment: Triple-Negative Breast Cancer current marketed and emerging therapies Triple-Negative Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Triple-Negative Breast Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Triple-Negative Breast Cancer Market Access and Reimbursement Download the report to understand which factors are driving triple-negative breast cancer market trends @ Triple-Negative Breast Cancer Market Forecast Table of Contents 1 Key Insights 2 Report Introduction 3 TNBC Market Overview at a Glance 3.1 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2020 3.2 Market Share (%) Distribution of TNBC by Therapies in the 7MM in 2034 4 Executive Summary 5 Key Events 6 Disease Background and Overview 6.1 Introduction 6.2 Various Subtypes of Breast Cancer Based on Immunohistochemical Expression 6.3 TNBC Overview 6.3.1 Intrinsic Molecular Subtypes in TNBC 6.3.2 Characteristics of Tumor Microenvironment in TNBC 6.3.3 Potential Risk Factors 6.3.4 Clinical Presentation 6.3.5 Characterization of HER2-low Breast Cancers 6.4 Diagnosis 6.4.1 Staging 6.4.2 Grading 6.4.3 Clinical Prognostic Stage 6.4.4 Pathological Prognostic Stage 6.4.5 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer 6.4.6 Recommendations for HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline Update 6.4.7 Diagnostic Algorithm 6.5 Treatment and Management 6.5.1 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer 6.5.2 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Early Breast Cancer 6.5.3 ESMO Clinical Practice Guideline for the Diagnosis, Staging, and Treatment of Patients with Metastatic Breast Cancer 6.5.4 Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for Breast Cancer – 2022 Update 6.5.5 Treatment Algorithm 7 Epidemiology and Market Forecast Methodology 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.2.1 Incident Cases of Breast Cancer 8.2.2 Incident Cases of TNBC 8.2.3 Gene Mutation-specific Incident Cases of TNBC 8.2.4 Stage-specific Incident Cases of TNBC 8.2.5 Age-specific Incident Cases of TNBC 8.3 Total Incident Cases of Breast Cancer in the 7MM 8.4 Total Incident Cases of TNBC in the 7MM 8.5 The United States 8.6 EU4 and the UK 8.7 Japan 9 Patient Journey 10 Marketed Therapies 10.1 Key Cross Competition 10.2 KEYTRUDA (pembrolizumab): Merck 10.2.1 Product Description 10.2.2 Regulatory Milestone 10.2.3 Other Developmental Activities 10.2.4 Clinical Trials Information 10.2.5 Safety and Efficacy 10.3 TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences 10.4 TALZENNA (talazoparib): Pfizer 10.5 LYNPARZA (olaparib): AstraZeneca/Merck 10.6 TECENTRIQ (atezolizumab): Roche/Genentech To be continued in the report… 11 Emerging Drug Profiles 11.1 Key Cross Competition of Emerging Drugs 11.2 DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo 11.2.1 Drug Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analysts' View 11.3 PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer 11.4 Tilarginine: Galera Therapeutics 11.5 BNT327/PM8002: BioNTech 11.6 IMFINZI (Durvalumab): AstraZeneca To be continued in the report… 12 TNBC: Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Attribute Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptake 12.5 Total Market Size of TNBC in the 7MM 12.6 Market Size of TNBC by Therapies in the 7MM 12.7 Market Size of TNBC in the United States 12.8 Market Size of TNBC in EU4 and the UK 12.9 Market Size of TNBC in Japan 13 Key Opinion Leaders' Views 14 Unmet Needs 15 SWOT Analysis 16 Market Access and Reimbursement 16.1 The United States 16.2 In EU4 and the UK 16.3 Japan 17 Acronyms and Abbreviations 18 Bibliography 19 Report Methodology Related Reports PD-L1 Inhibitors Market PD-L1 Inhibitors Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PD-L1 inhibitors companies including EQRX, CSTONE PHARMACEUTICALS, PFIZER, NOVARTIS, ARCUS BIOSCIENCES, AGENUS, TRACON PHARMACEUTICALS, SHANGHAI HENLIUS BIOTECH, INCYTE CORPORATION, among others. PARP Inhibitors Market PARP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PARP inhibitors companies including AstraZeneca, Merck, Janssen, Pfizer, Astellas, Pharma& Schweiz, AtlasMedx, AbbVie, GlaxoSmithKline, Pfizer, BeiGene, Allarity Therapeutics, among others. Triple-Negative Breast Cancer Pipeline Triple-Negative Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TNBC companies, including G1 Therapeutics, Inc., Gilead Sciences, Biotheus Inc., GlaxoSmithKline, AstraZeneca, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company, Merck, SynDevRx, Inc., Treadwell Therapeutics, AstraZeneca, Novartis Pharmaceuticals, NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., Phoenix Molecular Designs, Pure Biologics S.A., Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Tubulis GmbH, Hinova Pharmaceuticals, Primevax, ARCE Therapeutics, HC Biopharma, Casinvent, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. 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@ + 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
21-07-2025
- Business
- Yahoo
Cantargia Announces Preliminary Topline Efficacy Results From the Phase 2 TRIFOUR Trial of Nadunolimab in Advanced Triple-Negative Breast Cancer (TNBC)
LUND, SWEDEN / / July 17, 2025 / Cantargia (STO:CANTA) Nadunolimab added to carboplatin and gemcitabine (GC) did not impact the safety profile of the chemotherapy and was well tolerated with neutropenia and asthenia as the most common side effects The primary endpoint, overall response rate (ORR),was similar in the nadunolimab plus carboplatin/gemcitabine treated group and the carboplatin/gemcitabine reference group TRIFOUR is an exploratory open label randomized Phase 1b/2 clinical study conducted by the Spanish Breast Cancer Group (GEICAM).The objective is to evaluate early signals of efficacy of Cantargia's IL1RAP antibody nadunolimab in TNBC, with unconfirmed ORR as primary endpoint. The ORR was 40% in the Ph2 study in the nadunolimab plus GC treated patients. As reference, the ORR in the GC group was 43%. Subgroup analyses of the data are ongoing. The tolerability of the combination was acceptable and in line with previous trials combining nadunolimab and chemotherapy. Most common side effects in this trial were neutropenia and asthenia with no notable differences between the two study arms. "TNBC is a heterogeneous and difficult to treat disease, with a high unmet medical need. We welcome the efforts to explore new treatments and appreciate the learnings we are making from the TRIFOUR study. We now await the outcome of further analyses from the study, including overall survival," said Dr. Eva Carrasco, CEO of GEICAM. "We are pleased to have the opportunity to collaborate with GEICAM and explore nadunolimab in the TNBC indication. While the preliminary ORR results of the Phase 2 part of the TRIFOUR trial do not match those obtained in the Phase 1b part of the trial, the study continues and we will now await the mature survival data." said Damian Marron, interim CEO of Cantargia. "Following the signing of our CAN10 agreement earlier this week, we will be undertaking a detailed portfolio discussion to define our plans for the further development of nadunolimab". The TRIFOUR Ph1b/2 study first enrolled 15 patients in a preliminary phase 1b dose-ranging part, which showed an acceptable safety profile with promising efficacy including 73% unconfirmed ORR (60% confirmed) in first-line (1L) or second-line (2L) patients with metastatic TNBC. In the Phase 2 part of the trial, patients were randomized to two study groups with nadunolimab + GC treatment in the experimental group (n=51) and GC alone in the reference group (n=48). Nadunolimab (2.5 mg/kg) and GC were given twice per cycle in 3- or 4-week cycles. The objective of the study was to identify early signals of efficacy, with an internal GC group for reference. RECIST 1.1 criteria were used to evaluate the preliminary ORR which was based on a minimum of 2 CT scans (approx. 3 months treatment) from the 97 TNBC patients included in the efficacy analyses. Among these, 20 patients (40%) showed unconfirmed complete response (CR) or partial response (PR) in the nadunolimab + GC arm vs. 20 patients (43%) in the chemotherapy arm. This data in 1L and 2L patients is higher than the historical response rate of approximately 30% reported for GC alone in 1L, 2L and third-line patients [1], and similar to 1L TNBC patients treated with chemotherapy alone [2]. Nadunolimab has been tested in over 300 patients with metastatic cancer. Previous data in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) indications have shown promising results for nadunolimab in combination with chemotherapy in these indications [3,4], and nadunolimab is granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in PDAC patients with high expression levels of IL1RAP. Nadunolimab is currently being tested inpatients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in an investigator-initiated clinical study at The University of Texas MD Anderson Cancer Center. More details of the TRIFOUR study will be communicated at an upcoming scientific conference. References[1] O'Shaughnessy, J Clin Oncol 2014, 32:3840-3847[2] Cortes N Engl J Med 2022, 387: 217-226[3] van Cutsem et al, Clin Cancer Res 2024, 30: 5293-5303[4] Paulus et al, Lung Cancer 2025, For further information, please contactDamian Marron, Interim CEOTelephone: +46 (0)46-275 62 60E-mail: This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-07-17 21:30 CEST. About CantargiaCantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on hidradenitis suppurativa and systemic sclerosis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at About nadunolimab (CAN04)The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and the development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluates nadunolimab in combination with standard chemotherapies in patients with pancreatic ductal adenocarcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapies). Positive data show durable responses for combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase 1b/2 trial TRIFOUR, NCT05181462, also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. About GEICAMGEICAM is the leader group in breast cancer research in Spain with a recognized worldwide prestige. It is formed by more than 900 experts, who work in 220 institutions throughout its establishment in 1995 until now GEICAM has performed more than a hundred of studies in which almost 68,000 women and men have has a large multidisciplinary team specialized in the management of clinical trials and other studies, which collaborates with clinical researchers in the design and implementation of clinical trials, as well as in their execution and dissemination in forums and high-impact scientific more information, you can visit the official website or follow us on Twitter @GEICAM, @GEICAMujer, and on AttachmentsCantargia announces preliminary topline efficacy results from the phase 2 TRIFOUR trial of nadunolimab in advanced triple-negative breast cancer (TNBC) SOURCE: Cantargia View the original press release on ACCESS Newswire
Business Wire
15-07-2025
- Business
- Business Wire
Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment
DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a pioneering artificial intelligence (AI) company transforming oncology drug discovery and development, today announced the launch of an innovative AI-powered module within its proprietary RADR ® platform, designed to predict the activity and efficacy of combination regimens involving DNA-damaging agents (DDAs) and DNA damage response inhibitors (DDRis) in clinical cancer treatment. With the global market for combination cancer therapies projected to exceed $50 billion by 2030, growing at a CAGR of 8.5%, this module represents a significant advancement in precision oncology, enabling faster, more cost-effective development of tailored therapeutic regimens. Leveraging this AI-driven framework, Lantern Pharma has successfully architected and achieved FDA clearance for a Phase 1B/2 clinical trial in triple-negative breast cancer (TNBC), focusing on a novel DDA-DDRi combination regimen with promising preclinical efficacy. This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments. By leveraging our RADR® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided... Share In a peer-reviewed study published in Frontiers in Oncology, Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review, Lantern Pharma researchers systematically analyzed 221 DDA-DDRi combination-arm clinical trials, involving 22 DDAs and 46 DDRis, to develop this module. The study categorized DDAs into eight subclasses (e.g., alkylating agents, interstrand cross-linkers) and DDRis into 14 subclasses (e.g., PARP, ATR, WEE1 inhibitors). From these, 89 trials with interpretable outcomes were scored for clinical effectiveness, safety, and biomarker-driven responses, providing a robust dataset to train the AI module. 1 Transforming Cancer Combination Therapy Development The new AI module represents a paradigm shift in precision oncology, leveraging machine learning to predict which drug combinations will be most effective for specific patient populations while minimizing toxicity risks. This data-driven approach has already demonstrated its value by successfully guiding the design of Lantern's FDA-cleared Phase 1B/2 clinical trial combining LP-184 with olaparib in triple-negative breast cancer (TNBC). "This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments," said Panna Sharma, CEO & President of Lantern Pharma. "By leveraging our RADR ® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided the development of our TNBC trial. We believe this approach could reduce combination therapy development timelines and costs by one-third compared to traditional methods." The module integrates genomic, transcriptomic, and clinical data to predict synergistic drug interactions, optimize therapeutic outcomes, and identify biomarker-defined patient subpopulations likely to respond to specific combinations. This data-driven approach directly informed the design of Lantern's FDA-cleared Phase 1B/2 trial in TNBC for LP-184 and olaparib, with potential to improve response rates and reduce toxicity. Key insights from the study powering the AI module include: Non-PARP Inhibitor Promise: Non-PARP DDRi combinations, particularly WEE1 inhibitors like adavosertib with platinum agents, showed an 80% positive outcome rate in interstrand cross-linker trials, with strong efficacy in TP53-mutated cancers, directly informing future trial design. Biomarker-Driven Success: Biomarkers such as TP53 mutations and HRD signatures were critical predictors of response, enabling patient stratification to maximize efficacy. Toxicity Mitigation: The use of novel formulations like liposomal doxorubicin in combination regimens reduced cardiotoxicity, providing a safer backbone for combination strategies. Emerging Trends: The analysis emphasizes the patterns in treatment effectiveness, safety, and emerging trends across various cancer types and discusses the potential of biomarkers to guide treatment selection and improve patient outcomes. The module's multi-agentic framework integrates specialized AI agents for data aggregation, drug classification, predictive modeling, biomarker identification, and optimization, creating a dynamic system that is planned to evolve along with new data. The system's continuous learning capability ensures adaptability, enabling Lantern to refine regimens and accelerate future trials across diverse cancer indications. The company is exploring licensing and commercialization opportunities to expand the application of this technology, further revolutionizing combination therapy development. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its RADR ® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development, and improve patient outcomes. Please find more information at: Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. 1 Fontenot R, Biyani N, Bhatia K, Ewesuedo R, Chamberlain M and Sharma P (2025) Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review. Front. Oncol. 15:1577468. doi: 10.3389/fonc.2025.1577468
Health Line
08-07-2025
- Health
- Health Line
The Future of Treatments for Triple-Negative Breast Cancer
This type of breast cancer can be difficult to treat, but advances in therapeutic approaches are promising. Triple-negative breast cancer (TNBC) is a rare type of breast cancer that doesn't respond to common hormone-based therapies. However, other treatments are available. 'Triple-negative' describes cancer cells that test negative for three types of receptors: estrogen progesterone HER2 Because of its triple-negative status, TNBC doesn't respond to treatments that target estrogen or progesterone receptors. It also doesn't respond to the various HER2 cancer treatments. However, TNBC is sensitive to chemotherapy and immunotherapy, which can shrink tumors so they're easier to remove surgically. About 10% to 15% of all breast cancer types are of the triple-negative type. Most instances of TNBC are invasive ductal carcinoma, but ductal carcinoma in situ can also be estrogen-receptor and progesterone-receptor negative. The cell type, not the location, determines whether breast cancer is TNBC. Black and Latinx people are more likely to develop TNBC than those of other ethnicities. A 2021 study found that Black women were 2.7 times more likely than white women to receive a TNBC diagnosis. Many Black females don't have access to the insurance or resources they need to manage this type of cancer. They may experience delays between diagnosis and treatment and challenges communicating with doctors. People with mutations on their BRCA gene, especially on the BRCA1 gene, are also at risk for this type of breast cancer, as are those younger than age 50. Types of treatment Even though TBNC is harder to treat compared to other types of breast cancer, treatments continue to evolve. Chemotherapy A common TNBC treatment strategy is to begin with chemotherapy, either alone or in combination with an immunotherapy drug. This helps shrink tumors so they're easier to remove with surgery. It can also shrink affected lymph nodes. Some research suggests that neoadjuvant chemotherapy (chemotherapy that occurs before other treatments) can eliminate invasive breast cancer in about 30% to 50% of cases. Other studies have found that it is effective in over 58% of those with TNBC. Research has found that when chemo can eliminate TNBC, the 5-year event-free survival rate is 92% and the 10-year event-free survival rate is 87%. Event-free survival includes cancer recurrence and further complications. However, this is dependent upon the stage of the tumor. Your doctor might prescribe additional chemotherapy treatment after surgery. Chemotherapy after surgery is known as adjuvant chemotherapy and is performed to reduce the likelihood of a cancer recurrence. Surgery Surgery can be performed before or after chemotherapy. When an early stage TNBC tumor is small enough, treatment may begin with surgery. The surgeon will remove the tumor and check your lymph nodes. Surgery might involve: a lumpectomy, which removes the tumor while preserving breast tissue a mastectomy, which removes the entire breast a sentinel lymph node biopsy, which removes nearby lymph nodes Additional treatment may be needed after surgery to help improve outcomes. Immunotherapy Immunotherapy works by boosting your immune system and teaching it to target cancer cells by controlling the action of protein checkpoints that turn your immune response on or off. It can be used before or after surgery. Pembrolizumab (Keytruda) is an immunotherapy drug that targets the immune cell protein PD-1. This protein usually stops immune cells from attacking. Pembrolizumab prevents PD-1 from blocking immune system cells so they can attack breast cancer cells. About 1 in 5 instances of TNBC have the PD-1 protein. Targeted therapy Targeted therapy works by targeting specific proteins in breast cancer cells to slow or stop the cancer from growing and spreading. This type of treatment can also help you live longer. Targeted therapy can be used to help other types of treatment work better or in place of other interventions that aren't effective. One type of targeted therapy is an antibody drug conjugate, such as sacituzumab govitecan (Trodelvy). This attaches itself to a specific protein in the cancer cell to directly deliver chemotherapy to it. If you have a BRCA mutation, your doctor may recommend taking olaparib (Lynparza) or talazoparib (Talzenna). Radiation Radiation treatment is recommended if you elect for breast conservation with a lumpectomy. It can also be used if you've had a mastectomy with positive lymph nodes. Radiation treatment uses high energy radiation that destroys remaining breast cancer cells. There are two types of radiation treatment: external beam radiation and internal radiation. During external beam radiation, a machine outside your body will direct radiation to the target area. For brachytherapy, or internal radiation, a healthcare professional will place radioactive material inside your body, next to the cancer site. Clinical trials Clinical trials are research studies using human volunteers. Trials are available for all stages of cancer. If you're part of a clinical trial, you might have advanced access to new treatments. By participating in a trial, you will also contribute to improving medical knowledge and progress in cancer treatments. You can discuss the option of a clinical trial with your doctor. You can also find more information through the following online resources: Treatment considerations Your unique circumstances determine the approach to TNBC treatment. Your care team will develop a specific treatment plan based on your situation. In some cases, you'll have surgery first to remove the cancerous tumor, followed by other treatments to reduce the risk of cancer coming back, helping prolong your life. In other cases, you'll undergo treatment first to help shrink the tumors before having them surgically removed. Follow-up treatment may then also be recommended after surgery. People diagnosed with stage 4 TNBC rarely undergo surgery or radiation. However, they may be prescribed stronger types of chemotherapy, targeted therapy, or immunotherapy — or different combinations of these treatments — to help improve outcomes. Personalized treatment approach Newer treatment options, such as targeted therapy and immunotherapy, have advanced the personalized approach to TNBC treatment. The BRCA mutation may present an opportunity for a precision treatment approach. It occurs in about 20% to 30% of TNBC cancer instances and responds to treatment using poly (ADP-ribose) polymerase (PARP) inhibitors. Using pembrolizumab to target PD-1 is another personalized approach for TNBC cancer cells with this protein. For more advanced TNBC where other treatments aren't effective, using sacituzumab govitecan can be another personalized option. Research is also ongoing to determine whether the aggressive nature of TNBC in Black women is because of health issues such as obesity or factors like socioeconomic status, healthcare access, or cultural practices. This may lead to much-needed precision treatment approaches for Black women. However, TNBC can still be challenging to treat. This is mainly due to its aggressive nature and lack of certain protein receptors. There are also few outlook (related to a person's overall outcome, regardless of therapy) and predictive (related specifically to treatment outcomes) biomarkers. Outlook The National Cancer Institute (NCI) maintains a database called the Surveillance, Epidemiology, and End Results Program (SEER). The SEER database tracks 5-year relative survival rates by grouping cancers into categories based on how far they've spread. A relative survival rate compares a person with cancer against the overall population. For example, if you have breast cancer with a 90% 5-year relative survival rate, you're 90% as likely to live for 5 years as someone without this disease. According to the American Cancer Society, the SEER 5-year relative survival rates for TNBC are: 92% for localized (cancer is contained within the breast) 67% for regional (cancer is located in the breast and nearby lymph nodes and tissues) 15% for distant (cancer is located in distant areas like the liver, bones, or lungs) 78% for all stages combined These percentages have increased slightly in recent years, as treatment methods continue to evolve.
