Latest news with #KEYTRUDA®
Cision Canada
21-07-2025
- Business
- Cision Canada
Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹ Français
KIRKLAND, QC, July 21, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada has granted approval for KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. 1,2 The approval is based on data from the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, which demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients randomized to KEYTRUDA ® in combination with CRT compared with patients randomized to placebo plus CRT. 3 "The approval of KN-A18 is an important addition to the treatment of gynecological cancers, as it has demonstrated a statistically significant improvement in overall survival and progression-free survival in patients with FIGO 2014 Stage III-IVa," stated Shannon Salvador, Gynecologic Oncologist at the Jewish General Hospital and President of the Society of Gynecologic Oncology of Canada. 4"This recent approval adds another therapeutic option for patients in an important disease space." "This approval marks a pivotal moment for patients, as it represents the first indication in Canada for KEYTRUDA ® in combination with chemoradiotherapy," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "Reaffirming our commitment to cervical cancer, we are eager to continue expanding treatment options for patients impacted by this disease." 5 About KEYNOTE-A18 / ENGOT-cx11/GOG-3047 KEYNOTE-A18 is a multicenter, randomized, double-blind, placebo-controlled phase III trial ( NCT04221945). 2 The trial investigated the efficacy of pembrolizumab in combination with CRT (cisplatin and external beam radiation therapy [EBRT] followed by brachytherapy [BT]) for the treatment of patients with locally advanced cervical cancer. 1 The trial enrolled 1,060 newly diagnosed patients with locally advanced squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix defined as FIGO 2014 stage IB2 to IIB with positive lymph nodes or stage III to IVA regardless of nodal status. 3 There were 599 patients with FIGO 2014 Stage III-IVA. Randomization was stratified by planned type of EBRT (Intensity modulated radiation therapy [IMRT] or volumetric modulated arc therapy [VMAT] vs. non IMRT and non VMAT), stage at screening of cervical cancer (FIGO 2014 Stage IB2 IIB vs. FIGO 2014 Stage III-IVA), and planned total radiotherapy dose (EBRT + brachytherapy dose of <70 Gy vs. ≥70 Gy as per equivalent dose [EQD2]). 1 Patients were randomized (1:1) to one of two treatment arms: Pembrolizumab 200 mg IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by pembrolizumab 400 mg IV every 6 weeks (15 cycles). 1,3 Placebo IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice), and radiotherapy (EBRT followed by BT), followed by placebo IV every 6 weeks (15 cycles). 1,3 Treatment continued until RECIST (Response Evaluation Criteria in Solid Tumors) v1.1-defined progression of disease as determined by investigator or unacceptable toxicity. 1 Assessment of tumour status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year 3, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or histopathologic confirmation, and OS. 1 The trial demonstrated statistically significant improvements in both PFS (HR (Hazard Ratio) 0.70; 95% CI (confidence interval): 0.55–0.89; p = 0.002) and OS (HR 0.67; 95% CI: 0.50–0.90; p = 0.004) in the overall population. In an exploratory subgroup analysis for the 459 patients (43%) with FIGO 2014 Stage IB2–IIB disease, the PFS and OS HR estimates were 0.91 (95% CI: 0.63–1.32) and 0.89 (95% CI: 0.55–1.44), respectively, suggesting that the improvements in PFS and OS observed in the overall population were primarily driven by the later-stage subgroup of patients with FIGO 2014 Stage III–IVA disease. The efficacy results in the exploratory subgroup analysis of 599 patients with FIGO 2014 Stage III-IVA disease showed that pembrolizumab plus CRT demonstrated improvements in PFS (Hazard Ratio (HR) 0.59; 95% CI 0.43, 0.81) and OS (HR 0.58; 95% CI 0.40, 0.85) in the overall population. 1 For the FIGO 2014 Stage III-IVA population, the most common treatment-related adverse events (reported in at least 20% of patients) were anemia, nausea, diarrhea, white blood cell count decreased, neutrophil count decreased, vomiting, platelet count decreased, and hypothyroidism. 6 For complete information, refer to the KEYTRUDA ® product monograph. About cervical cancer Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. 7 Despite concerted efforts in screening and prevention across Canada, cervical cancer has become the fastest growing cancer type in females. 8,9 In 2024 alone, it was estimated that there were approximately 1,600 women diagnosed with cervical cancer and an estimated 400 deaths as a result of the disease. 10 About KEYTRUDA ® KEYTRUDA ® is an anti-programmed death receptor-1 (anti-PD-1) therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA ® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 11,12,13 KEYTRUDA ® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. 14 About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit and connect with us on LinkedIn @MerckCanada. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( ® Merck Sharp & Dohme LLC. Used under license. © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. CA-NON-04142 1 KEYTRUDA ® Product Monograph, page 285-286. 2 3 The ASCO Post. KEYNOTE-A18: Overall Survival in Cervical Cancer Improved by Pembrolizumab Plus Chemoradiotherapy. 4 Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial, page 1329. 5 6 KEYTRUDA ® Product Monograph, page 146. 7 Canadian Cancer Society. What is cervical cancer? 8 Canadian Cancer Statistics 2023, page 22. 9 Canadian Cancer Statistics 2023, page 80. 10 Canadian Cancer Society. Cervical cancer statistics. 11 KEYTRUDA ® Product Monograph, page 300. 12 KEYTRUDA ® Product Monograph, page 188. 13 KEYTRUDA ® Product Monograph, page 192. 14 KEYTRUDA ® Product Monograph, pages 1-3. Media Contacts: Merck Canada Media Relations 1-833-906-3725 [email protected]
Yahoo
27-05-2025
- Business
- Yahoo
Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
Novel combination with efti has met the trial's primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting SYDNEY, AUSTRALIA, May 27, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ('Immutep' or 'the Company'), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial's investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial's principal investigators, said: 'It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year.' As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3 For more information on EFTISARC-NEO, visit (NCT06128863). About Eftilagimod Alfa (efti)Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/ Epub 2017 Feb 24. PMID: 28463157.2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.3. American Cancer Society statistics: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; 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
27-05-2025
- Business
- Yahoo
Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
Novel combination with efti has met the trial's primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting SYDNEY, AUSTRALIA, May 27, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ('Immutep' or 'the Company'), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study's prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial's investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial's principal investigators, said: 'It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year.' As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3 For more information on EFTISARC-NEO, visit (NCT06128863). About Eftilagimod Alfa (efti)Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system's ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/ Epub 2017 Feb 24. PMID: 28463157.2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.3. American Cancer Society statistics: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
23-05-2025
- Business
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Antengene to Present Latest Clinical Results from Two Studies in CPI-resistant Solid Tumors at ASCO 2025
ATG-037, an oral small molecule CD73 inhibitor, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), achieved an overall response rate (ORR) of 36.4% and disease control rate (DCR) of 100% in checkpoint inhibitor (CPI)-resistant melanoma patients in the ongoing STAMINA-01 trial, with one patient maintaining a partial response (PR) and remained on treatment for over 2 years without any safety concerns. In CPI-resistant non-small cell lung cancer (NSCLC), the combination of ATG-037 and pembrolizumab achieved an ORR of 22% and DCR of 67% in the same study. ATG-008, an oral dual mTORC1/2 inhibitor, in combination with toripalimab, achieved an ORR of 22.2% and DCR of 85.2% in CPI-resistant cervical cancer patients in the ongoing TORCH-2 trial. SHANGHAI and HONG KONG, May 22, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it will present the latest clinical data of its CD73 oral small molecule inhibitor ATG-037 and oral dual mTORC1/2 inhibitor ATG-008 in Poster Presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30th to June 3rd in Chicago, IL, the United States. Details of the Poster Presentations:ATG-037 (CD73 Small Molecule Inhibitor)Title: A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumors - STAMINA-01Abstract: 3123Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor BiologyDate: June 2, 2025Time: 1:30 PM - 4:30 PM (Central Time) 2:30 AM - 5:30 AM, June 3, 2025 (Beijing Time) Robust clinical benefit observed in CPI-resistant patients: As of April 27, 2025, the study has already completed the dose escalation part in which 43 patients were enrolled and received monotherapy. Among them, 28 CPI-resistant patients also received the combination therapy. Among patients treated with the combination therapy, 6 patients (4 melanoma and 2 NSCLC patients) achieved a confirmed PR with an ORR of 21.4%, and 16 patients achieved stable disease (SD) with a DCR of 78.6%. The combination regimen delivered particularly encouraging efficacy in melanoma, with all 11 CPI-resistant patients achieving disease control (DCR 100%) and an ORR of 36.4% (4 PRs), including 1 patient having maintained PR and remained in the study for over 2 years without any safety concerns. In CPI-resistant NSCLC, the combination regimen achieved an ORR of 22% (PRs) and a DCR of 67%. These results highlight the potential of ATG-037 to deliver meaningful clinical benefit across multiple tumor types, reinforcing its promise as a novel treatment option in CPI-resistant cancers. Manageable safety profile: Treatment-related adverse events were reported in 56% (24/43) of patients receiving monotherapy and 61% (17/28) of patients receiving the combination therapy. The majority of these TRAEs were grade 1-2. Only one serious TRAE (grade 3 immune mediated hepatitis) was observed in the study. Two key differentiators: ATG-037 is an oral small molecule CD73 inhibitor offering greater convenience over intravenous (IV) injectable agents and is uniquely designed to overcome the 'hook effect' commonly seen in anti-CD73 antibodies, enabling complete and more effective CD73 inhibition. The STAMINA-01 trial: STAMINA-01 is a Phase I/Ib study jointly conducted by Antengene and MSD (Merck & Co., Inc., Rahway, NJ, USA). The study was designed to evaluate the safety, pharmacokinetics, and optimal dosing of ATG-037 as a monotherapy and in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with refractory/relapsed solid tumors. At present, dose optimization and dose expansion parts of the study are being carried out as planned in China and Australia. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ATG-008 (mTORC1/2 Small Molecule Inhibitor)Title: A TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced cervical cancers with prior anti-PD-(L)1 therapyAbstract: 5540Session: Gynecologic CancerDate: June 1, 2025Time: 9:00 AM - 12:00 PM (Central Time) 10:00 PM, June 1, 2025 - 1:00 AM, June 2, 2025 (Beijing Time) The TORCH-2 trial: ATG-008 is an oral dual mTOR1/2 inhibitor. The TORCH-2 trial is a Phase I/II dose escalation and dose expansion study of ATG-008 in combination with the anti-PD-1 monoclonal antibody toripalimab in patients with advanced solid tumors. This abstract reports data from patients with advanced cervical cancer who had previously received at least prior 1 line of anti-PD-(L)1 therapy and 1 line of platinum chemotherapy, regardless of the PD-L1 expression. As of November 25, 2024, 30 qualified patients were enrolled and received ATG-008 15 mg orally once a day (QD) in combination with toripalimab 240 mg, once every 21 days (Q3W). Among them, 14 and 16 patients had received 1 and at least 2 prior lines of systemic therapy, respectively. The median time since initial diagnosis was 37 months. Encouraging efficacy in patients with CPI-resistant cervical cancer: Among 27 efficacy-evaluable patients, the combination regimen achieved an ORR of 22.2% and a DCR of 85.2%. The ORRs of PD-L1 positive and PD-L1 negative populations were 30% (3/10) and 33.3% (2/6), respectively. The median time to response was 1.7 months (1.4, 4.2) and the median duration of response (DOR) was 5.7 months (95% CI: 2.7, NE). The median progression-free survival (PFS) was 4.2 months (95% CI: 3.3, 5.8) and the median overall survival (OS) was 21.4 months (95% CI: 15.5, NE). These results underscore the potential of ATG-008 in combination with toripalimab in providing meaningful clinical benefit for CPI-resistant cervical cancer patients, reinforcing its promise as a novel treatment option for this difficult-to-treat patient population. Manageable safety profile: All 30 patients experienced at least one TEAE, and 22 patients (73.3%) reported grade ≥3 TRAEs. The most common all-grade TRAEs were hyperglycaemia (56.7%), rash (43.3%) and white blood cell decreased (43.3%). Most TRAEs were grade 1-2, and no TEAE led to death. About Antengene Antengene Corporation Limited ("Antengene", SEHK: is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald LungE-mail: Mobile: +86 18420672158 PR Contacts:Peter QianE-mail: +86 13062747000 View original content to download multimedia: SOURCE Antengene Corporation Limited
Yahoo
20-05-2025
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Merck (NYSE:MRK) Collaborates With Antengene For Promising Cancer Therapy Evaluation
In a recent development, Antengene Corporation Limited announced a global clinical collaboration with Merck to evaluate ATG-022 in combination with KEYTRUDA®, which could enhance Merck's oncology portfolio. Despite this collaboration and other positive product-related announcements, Merck's stock price was relatively flat over the past month at a 1% decline. During this time, the broader market posted gains, driven by easing trade concerns and strong corporate earnings. The developments from Merck, although significant, added weight to the broad market trends rather than diverging substantially from them, demonstrating Merck's steady position amidst sector-wide moves. Every company has risks, and we've spotted 1 weakness for Merck you should know about. Rare earth metals are the new gold rush. Find out which 23 stocks are leading the charge. The recent collaboration between Antengene and Merck to evaluate ATG-022 with KEYTRUDA could potentially bolster Merck's oncology portfolio, aligning with their narrative of increasing leadership in this sector. However, while this partnership might enhance research and development outcomes, the one-month stock price, showing a 1% decline despite broader market gains, suggests limited immediate impact. Over the longer term, Merck's total shareholder return, incorporating both stock price and dividends, was 23.65% over five years, reflecting overall positive growth. Yet, over the past year, Merck underperformed the US Pharmaceuticals industry, which had a 9.5% decline, illustrating sector-wide challenges. The global clinical collaboration might positively influence Merck's revenue and earnings forecasts, integrating into the company's strategy of launching over 20 new growth drivers with potential for blockbuster success. Analysts project continued revenue growth at 4.4% annually over the next three years. The current share price of US$79.04, compared to the analyst consensus price target of US$102.56, indicates potential upside evaluation. As the company forecasts earnings growth, securing a favorable PE ratio will be critical to reaching those price targets. Merck's response to competition and regulatory challenges will further determine the tangible outcomes of this collaboration in enhancing shareholder value. Gain insights into Merck's historical outcomes by reviewing our past performance report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:MRK. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
