Weekly Digest - 18-24 Jul 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 18-24 Jul 2023
21 Jul 2023: Pembrolizumab / Trastuzumab / HER2+ Advance Gastric or GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1) / Merck: Received positive EU CHMP opinion
- The recommendation was based on interim results from the Phase 3 KEYNOTE-811 trial in which Keytruda regimen demonstrated statistically significant improvement in PFS and ORR compared to trastuzumab and chemotherapy alone
- KEYNOTE-811 is a Phase 3 trial evaluating Pembro plus Trastuzumab and Chemo as 1L treatment for HER2+ Advance Gastric or GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)
- More than 80% of patients in the study had PD-L1 positive tumor
- These PFS results will be presented at an upcoming medical meeting
- If approved, KEYTRUDA would become the first immunotherapy in the EU for the 1L treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1)
- “This positive CHMP opinion reinforces our commitment to bringing meaningful treatment options to patients living with HER2-positive gastric or GEJ cancer, whose tumors express PD-L1 with a combined positive score ≥1, in the European Union,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories
