Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as First-Line Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.

“Patients diagnosed with locally advanced unresectable or metastatic biliary tract cancer face a challenging disease with poor survival outcomes, underscoring the need for new treatment options that may help extend their lives,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has shown an overall survival benefit compared to chemotherapy alone, to these patients in the European Union.”

The recommendation is based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.

In October 2023, the U.S. Food and Drug Administration (FDA) approved the use of KEYTRUDA in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.

About biliary tract cancer

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

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