Merck, known as MSD outside the US and Canada, secured two new KEYTRUDA approvals in the EU for gastrointestinal cancers:
- KEYTRUDA combined with fluoropyrimidine-platinum chemotherapy for first-line treatment of locally advanced or metastatic HER2-negative gastric/GEJ adenocarcinoma in adults expressing PD-L1 (CPS ≥1).
- KEYTRUDA combined with gemcitabine and cisplatin for first-line treatment of unresectable or metastatic biliary tract carcinoma in adults.
The EC approvals were backed by positive recommendations from the Committee for Medicinal Products for Human Use and were based on OS outcomes from KEYNOTE-859 and KEYNOTE-966 Phase 3 trials.
KEYTRUDA Demonstrates Significant Survival Benefits in Gastrointestinal Cancers
In KEYNOTE-859, KEYTRUDA plus chemotherapy notably enhanced OS in the overall population and PD-L1-positive patients. KEYTRUDA reduced the risk of death by 22% in the overall population and by 26% in the PD-L1-expressing group. KEYNOTE-966 showcased a statistically significant improvement in OS with KEYTRUDA plus chemotherapy, reducing the risk of death by 17% compared to chemotherapy alone.
These approvals expand KEYTRUDA’s reach in treating gastrointestinal cancers, totaling seven indications based on clinical data in the EU. Merck aims to continue expanding treatment options for patients in Europe through its extensive KEYTRUDA clinical development program.
Resource: Merck, December 18, 2023
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