Latest news with #KEYTRUDA®
Cision Canada
3 days ago
- Business
- Cision Canada
Health Canada Approves KEYTRUDA® for Patients with Resectable Locally Advanced Head & Neck Squamous Cell Carcinoma Tumours that are PD-L1 (CPS) Positive as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as Monotherapy Français
Approval is based on KEYNOTE-689 Phase III Clinical Trial Results KIRKLAND, QC, Aug. 13, 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, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1), as determined by a validated test, as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy. The approval is based on data from the Phase 3 KEYNOTE-689 trial, which demonstrated positive clinical outcomes in patients with resectable locally advanced HNSCC whose tumours expressed PD-L1 (CPS ≥ 1). Perioperative KEYTRUDA ® in combination with adjuvant radiotherapy with or without cisplatin reduced the risk of event free survival (EFS) by 30% (Hazard Ration [HR]=0.70 [95% Confidence Interval [CI]: 0.55–0.89; p=0.0014]) compared to adjuvant radiotherapy with or without cisplatin. "We know that head and neck squamous cell carcinomas present significant treatment challenges because of their complexity," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "The introduction of a perioperative anti-PD-1 treatment option for eligible patients in Canada represents an important development with the potential to make a meaningful difference for patients and their families impacted by this disease." About KEYNOTE-689 KEYNOTE-689 is a randomized, multicenter, open label, active-controlled Phase III trial ( NCT03765918) evaluating pembrolizumab in patients with resectable locally advanced (Stage III-IVA) head and neck squamous cell carcinoma (HNSCC). Randomization was stratified by primary tumour site (oropharynx/oral cavity vs. larynx vs. hypopharynx), tumour stage (III vs. IVA) and PD-L1 status (Tumour Proportion Score [TPS] ≥ 50% vs TPS < 50%). The study enrolled 714 patients who were randomized (1:1) to receive one of two treatment arms: Neoadjuvant pembrolizumab 200 mg for 2 cycles every 3 weeks prior to surgical resection. Within 6 weeks following surgery, pembrolizumab 200 mg for 3 cycles in combination with either radiation + 3 cycles of cisplatin 100 mg/m 2 every 3 weeks for patients with high-risk pathological features after surgery or radiation alone for patients without high-risk pathological features after surgery. This was followed by pembrolizumab 200 mg every 3 weeks for up to 12 cycles. No neoadjuvant treatment prior to surgery. Within 6 weeks following surgery, either radiation + 3 cycles of cisplatin 100 mg/m 2 every 3 weeks for patients with high-risk pathological features after surgery or radiation alone for patients without high-risk pathological features after surgery. High-risk pathological features included the presence of positive margins or extranodal extension following surgical resection. Treatment with pembrolizumab continued until completion of the treatment (17 cycles), disease progression that precluded definitive surgery, disease recurrence in the adjuvant phase, disease progression for those who did not undergo surgery or had incomplete resection and entered the adjuvant phase, or unacceptable toxicity. Assessment of tumour status was performed prior to surgery at Week 6 in the neoadjuvant phase. Following the start of the adjuvant phase, assessment of tumour status was performed 12 weeks after the end of RT ± cisplatin treatment and then every 3 months until the end of Year 3; then every 6 months thereafter up to the end of Year 5. The primary efficacy outcome measure was event-free survival (EFS) by Blinded Independent Central Review (BICR) defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant disease progression or recurrence, or death due to any cause. Secondary primary malignancy was not considered an event. An additional efficacy outcome measure was overall survival (OS). Among the CPS ≥1 population, at the time of the first pre-specified interim analysis, the EFS HR was 0.70 (95% CI, 0.55-0.89; p=0.00140) and the number of events was 128 (37%) in the pembrolizumab arm versus 156 (47%) in the RT +/- cisplatin arm. The median EFS was 59.7 months (95% CI, 37.9-not reached) versus 29.6 months (95% CI, 19.5-41.9), in the pembrolizumab and RT +/- cisplatin arms respectively. The most common treatment-related adverse events for patients treated with pembrolizumab in KEYNOTE-689 (reported in at least 20% of patients) were radiation skin injury and stomatitis. The most common Grade 3-5 treatment-related adverse events (reported in at least 5% of patients) were stomatitis (11.6%), lymphocyte count decreased (5.5%), and neutrophil count decreased (5.3%). For complete information, refer to the KEYTRUDA ® product monograph. About head and neck cancer Head and neck cancer are comprised of a group of cancers that develop in or around the mouth, nose, throat, sinuses, larynx or voice box and saliva glands. In Canada, it was estimated that there were approximately 8,100 new cases of head and neck cancer diagnosed and more than 2,100 deaths from the disease in 2024. Most head and neck cancers begin in the squamous cells that line the mucosal surfaces such as the mouth, throat and voice box. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use, human papillomavirus (HPV), occupation exposure to certain substances, genetic history and pool oral hygiene. 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. 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. 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-04264 Media Contacts:
Yahoo
5 days ago
- Business
- Yahoo
IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed
Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study's statistical significance threshold of p≤0.045 In patients enrolled in this study without prior neo-adjuvant/adjuvant anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs. 11.0 months for the control arm Improvement in PFS was achieved across virtually all subgroups, including those with poor prognostic factors A profound effect was observed in patients with PD-L1 negative tumors treated with Cylembio plus pembrolizumab, HR: 0.54 (CI 0.35-0.85) (nominal p=0.006), with mPFS of 16.6 months vs. 3.0 months for the control arm A trend towards improvement in overall survival (OS) was observed in patients treated with Cylembio plus pembrolizumab (OS not yet mature), HR=0.79 (CI 0.57-1.10) Cylembio plus pembrolizumab was well tolerated, with no new safety signals observed IO Biotech plans to meet with the FDA this fall to discuss the data and next steps for a potential regulatory submission Company to host conference call today at 8:30 a.m. ET to discuss these results NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT) today announces topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted). The trial evaluated Cylembio in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated clinical improvement in progression free survival compared to pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint. 'In this study, we observed a highly encouraging improvement in progression free survival and consistent trend in overall survival in patients treated with Cylembio,' said Mai-Britt Zocca, PhD, president and chief executive officer of IO Biotech. 'The magnitude and durability of clinical effect observed consistently across subgroups supports our confidence in Cylembio and its potential as a treatment for advanced melanoma patients. We look forward to engaging with the FDA to determine a potential path to approval based on these data.' The randomized, open-label study enrolled 407 patients across more than 100 sites worldwide. Patients received either Cylembio in combination with pembrolizumab (n=203) or pembrolizumab alone (n=204). The primary endpoint was PFS as assessed by a blinded independent review committee per RECIST v1.1. The early and sustained separation of PFS curves demonstrated an improvement with a hazard ratio of 0.77 [95% CI: 0.58-1.00; p=0.056; threshold for significance p≤0.045]. Based on an intent-to-treat analysis, patients in the study treated with Cylembio in combination with pembrolizumab achieved 19.4 months of median progression free survival compared to 11.0 months in patients treated with pembrolizumab alone. Although not yet mature, a trend toward an improvement in overall survival was also observed [HR 0.79 (95% CI: 0.57-1.10)]; the company expects OS to mature over the next six to nine months. Improvement in PFS was achieved across virtually all subgroups, including those with poor prognostic factors, with a profound effect in patients with PD-L1 negative tumors treated with Cylembio plus pembrolizumab (n=67) compared to patients treated with pembrolizumab monotherapy (n=63), HR: 0.54 (CI 0.35-0.85) (nominal p=0.006), with mPFS of 16.6 months vs. 3.0 months, respectively. Additionally, in a post hoc analysis of patients enrolled in this study without prior anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS compared to patients treated with pembrolizumab monotherapy, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs. 11.0 months, respectively. The combination was well tolerated, with no new safety signals observed. Injection site reactions, which were transient and resolved on treatment, were the most commonly reported adverse events in the combination arm, with 56% of patients receiving Cylembio plus pembrolizumab reporting an event. 'In this study, patients treated with Cylembio in combination with pembrolizumab have achieved the longest median PFS ever observed in a Phase 3 clinical study in advanced melanoma, and in the PD-L1 negative population, patients achieved a remarkable 16.6 months of median PFS, compared to 3.0 months in patients treated with pembrolizumab alone,' said Omid Hamid, MD, Director, Clinical Research and Immunotherapy at The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate. 'The significant benefit seen across patients with poor prognostic factors, including PD-L1 negative patients, cannot be overlooked. Given the notable safety profile and the strong clinical effect observed with Cylembio, as well as the unmet need in advanced melanoma patients, Cylembio, if approved, has the potential to become a new standard of care for patients with advanced melanoma.' 'These data show the potential of a therapeutic cancer vaccine in patients with metastatic melanoma,' said Jessica Hassel, MD, Professor at the Department of Dermatology and National Center for Tumor Diseases at the University Hospital Heidelberg, Germany, and lead enrolling investigator for the Phase 3 trial. 'We were thrilled to play such an important part in this study and to have had the ability to offer our patients an investigational therapy that potentially offers improvements in PFS while not adding significant systemic toxicity.' 'Delaying progression and improving survival is the ultimate treatment goal for patients and although overall survival is not yet mature, the trend we are seeing in OS with separation of the curves is encouraging, with a consistent PFS clinical improvement and OS trend favoring the combination arm across virtually all subgroups, with no new safety signals or significant additional systemic toxicity,' said Qasim Ahmad, MD, chief medical officer of IO Biotech. 'We are deeply grateful to the patients for their participation in this study, as well as to investigators and study coordinators whose dedication and collaboration brings us one step closer to delivering a new treatment option to patients in need.' 'Since reporting the positive outcome of our Phase 1/2 study (MM1636) in a similar patient population, we have been eagerly awaiting these results supporting the activity of Cylembio combined with an anti-PD-1 in patients with advanced melanoma,' said Inge Marie Svane, MD, PhD, Professor, Director of the National Center for Cancer Immune Therapy (CCIT) at the Copenhagen University Hospital, Herlev and Principal Investigator in the Phase 3 trial. 'These data provide evidence that a therapeutic cancer vaccine can improve progression free survival in patients with metastatic disease.' Based on these results, IO Biotech plans to meet with the United States (US) Food and Drug Administration (FDA) this fall to discuss the totality of data and determine next steps for submission of a Biologics License Application (BLA) for the treatment of advanced melanoma. Additionally, the company plans to present more detailed results from the IOB-013 study at an upcoming medical meeting. Conference Call and Webcast Information IO Biotech management will hold a conference call and webcast today at 8:30 a.m. ET to discuss these clinical data results. Participants can register for the live webcast here. The live webcast and replay will be available through IO Biotech's website here. About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial IOB-013/KN-D18 ( NCT05155254) was an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. About Cylembio® Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio. Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada). About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement 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. Forward-looking statements, including statements regarding the timing or outcome of communications with the FDA, submission of a BLA, the launch of Cylembio, and statements regarding other current or future clinical trials, their progress, enrollment or results, or the company's financial position or cash runway, are based on IO Biotech's current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contacts: InvestorsMaryann Cimino, Director of Investor RelationsIO Biotech, Inc.617-710-7305mci@ MediaJulie beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
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
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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
