Merck’s Keytruda (pembrolizumab) Receives EC’s Approval in Combination with Trastuzumab as 1L Treatment for HER2-Positive Advanced Gastric Cancer
Shots:
- The EC has approved Merck’s Keytruda (anti-PD-1 therapy) in combination with trastuzumab, fluoropyrimidine- and Pt-containing CT as 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1
- The approval was based on results from the P-III trial (KEYNOTE-811) evaluating Keytruda (200mg, q3w) + trastuzumab and CT vs trastuzumab and CT alone in 732 patients which showed significant improvement in PFS, & ORR, ≥80% of patients had tumors that were PD-L1+
- Trend toward improvement in OS in the ITT population but these results did not meet statistical significance per the pre-specified statistical analysis plan. The results will be presented at ESMO 2023
Ref: Merck | Image: Merck
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
