Source – Merck
A new hope for patients with advanced gastric or GEJ cancer that is positive for both HER2 and PD-L1 has emerged from the CHMP of the EMA. The CHMP has issued a positive opinion for a new combination therapy that includes KEYTRUDA, Merck’s immunotherapy drug that blocks the PD-1 pathway, plus trastuzumab, a targeted therapy that binds to the HER2 receptor, and chemotherapy. The positive opinion is based on the interim results of the Phase 3 KEYNOTE-811 trial, which compared the efficacy and safety of the KEYTRUDA regimen with trastuzumab and chemotherapy alone in this patient population. The trial showed that the KEYTRUDA regimen significantly improved PFS and ORR in patients whose tumors expressed PD-L1 (CPS ≥1), meaning that they had more than 1% of tumor cells or immune cells expressing PD-L1. The trial enrolled more than 80% of patients with PD-L1 positive tumors, indicating a high unmet need for this group of patients. The PFS results will be shared at a future medical meeting.
The CHMP’s recommendation will now be reviewed by the European Commission, which will make a final decision on granting marketing authorization to this combination therapy in the EU by the third quarter of 2023. If approved, this would be the first immunotherapy-based regimen for HER2-positive gastric or GEJ cancer in the EU. KEYTRUDA was already approved by the FDA in May 2021 for this indication in the U.S. under accelerated approval based on ORR data from KEYNOTE-811, which showed that 74% of patients who received the KEYTRUDA regimen had a response, compared with 52% of patients who received trastuzumab and chemotherapy alone. The accelerated approval means that the FDA requires further evidence of clinical benefit to confirm the approval. Merck is working with the FDA to update this indication to patients whose tumors are PD-L1 positive, as this subgroup showed the most benefit from the KEYTRUDA regimen.
“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. We look forward to the European Commission’s decision and are excited at the possibility of bringing the first approved immunotherapy regimen for the first-line treatment of these patients with HER2-positive advanced gastric or GEJ cancer to the EU.”
– Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories
Merck has a comprehensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is investigating KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal, and colorectal cancers. Merck is also collaborating with other companies and researchers to explore novel combinations and biomarkers for KEYTRUDA in these cancers.
