Health Canada Approves KEYTRUDA® for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy

Approval is based on the Phase 3 KEYNOTE-966 Trial

KIRKLAND, QC, May 9, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with gemcitabine-based chemotherapy, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC). This approval is based on the results from the Phase 3 KEYNOTE-966 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone.

"Biliary tract cancer is usually diagnosed at an advanced stage, where patient survival rates are poor," says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "The addition of this indication shows promising overall survival results, which means more potential treatment options for biliary cancer patients in urgent need."

About KEYNOTE-966

KEYNOTE-966 was a multicentre, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov NCT04003636) evaluating pembrolizumab in combination with gemcitabine and cisplatin compared to placebo plus gemcitabine and cisplatin for the first-line treatment of advanced and/or unresectable BTC. The primary endpoint was OS, and the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), as assessed by BICR according to RECIST v1.1.

The trial enrolled 1,069 patients with locally advanced unresectable or metastatic BTC, who had not received prior systemic therapy in the advanced disease setting. Patients were randomized (1:1) to receive pembrolizumab (200 mg every three weeks for up to approximately two years) plus gemcitabine and cisplatin, or placebo plus gemcitabine and cisplatin. Treatment continued until unacceptable toxicity or disease progression. For pembrolizumab, treatment continued for a maximum of 35 cycles, or approximately 24 months. For cisplatin, treatment could be administered for a maximum of 8 cycles and for gemcitabine, treatment could be continued beyond 8 cycles.

Pembrolizumab with the gemcitabine/cisplatin arm demonstrated a clinically meaningful and statistically significant improvement versus the placebo with gemcitabine/cisplatin arm in OS. In the study, there was a 17% reduction in the risk of death with pembrolizumab plus gemcitabine/cisplatin (HR=0.83 [95% CI, 0.72-0.95]; p=0.0034) versus gemcitabine/cisplatin alone. The median PFS was 6.5 months (95% CI, 5.7-6.9) for the pembrolizumab plus chemotherapy arm versus 5.6 months (95% CI, 5.1,6.6) for the placebo plus chemotherapy arm. The objective response rate at the pre-specified interim analysis was 28.7% (24.9, 32.8) versus 28.5% (24.8, 32.6) respectively.

The most common treatment-related adverse events (reported in at least 20% of patients) were neutrophil count decreased, anemia, platelet count decreased, nausea, fatigue, and white blood cell count decreased.

For complete information, refer to the KEYTRUDA® product monograph.

About Biliary Tract Cancer

Biliary tract cancer is a group of rare and highly aggressive cancers in the gallbladder and bile ducts. Biliary tract cancer is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 15% of all liver cancers. It is estimated there are approximately 211,000 new cases of BTC diagnosed and 174,000 deaths from the disease each year globally. Biliary tract cancer is most frequently diagnosed in patients between 50 to 70 years old, and 60-70% of BTC patients are diagnosed at an advanced stage. Patients diagnosed with BTC face a very poor prognosis, as the five-year survival rate is estimated to be between 5% and 15%.

About KEYTRUDA®

KEYTRUDA® is an anti-programmed death receptor-1 (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 www.merck.ca and connect with us on LinkedIn and X @MerckCanada.

Forward-Looking Statement of Merck & Co. Inc., Rahway, NJ, 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 (www.sec.gov).

Please see the product monograph for KEYTRUDA® (pembrolizumab) at Merck.ca.

® Merck Sharp & Dohme LLC. Used under license.
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SOURCE Merck Canada Inc.


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