Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹
Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹ |
| [21-July-2025] |
Approval is based on the results fromphase IIIKEYNOTE-A18/ENGOT-cx11/GOG-30472 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 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:
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 About KEYTRUDA® 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 Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA 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 (www.sec.gov). ® Merck Sharp & Dohme LLC. Used under license. CA-NON-04142 References: 1 KEYTRUDA® Product Monograph, page 285-286. Media Contacts: Merck Canada Media Relations SOURCE Merck | ||
Company Codes: NYSE:MRK |
