FDA approves first-line Keytruda-based regimen for advanced HER2-positive gastric cancer
Click Here to Manage Email Alerts
The FDA granted accelerated approval to a pembrolizumab-based combination for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
This approval applies to use of pembrolizumab (Keytruda, Merck) with trastuzumab (Herceptin, Genentech) and fluoropyrimidine- and platinum-containing chemotherapy.
Data from an interim analysis of the ongoing randomized, placebo-controlled, multicenter KEYNOTE-811 trial supported the approval. The trial included patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who had not received prior systemic therapy for metastatic disease. Researchers randomly assigned patients 1:1 to receive trastuzumab and fluorouracil plus cisplatin or capecitabine plus oxaliplatin with either placebo or 200 mg pembrolizumab every 3 weeks.
Overall response rate, assessed by a blinded independent review committee, was 74% (95% CI, 66-82) among patients assigned the pembrolizumab combination compared with 52% (95% CI, 43-61) among those assigned placebo (P < .0001). Median duration of response was 10.6 months (range, 1.1+ to 16.5+) in the pembrolizumab group compared with 9.5 months (range, 1.4+ to 15.4+) in the placebo group.
Researchers observed no new safety signals associated with pembrolizumab.
The application, reviewed using the Real-Time Oncology Review pilot program, previously received priority review.
Click Here to Manage Email Alerts