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FDA Accelerated Approval for Pembrolizumab in HER2-Positive Gastric Cancer
August 2021: Pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy has been granted accelerated approval by the Food and Drug Administration for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The KEYNOTE-811 (NCT03615326) trial, a multicenter, randomised, double-blind, placebo-controlled trial in patients with HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who had not previously received systemic therapy for metastatic disease, received approval based on a prespecified interim analysis of the first 264 patients. Pembrolizumab 200 mg or placebo was given to patients every three weeks in conjunction with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.
KEYNOTE-811 Trial Efficacy Results: Response Rates and Duration
The overall response rate (ORR) was the primary efficacy metric used in this study, which was examined by a blinded independent review committee. The ORR in the pembrolizumab arm was 74 percent (95 percent CI 66, 82) and in the placebo arm was 52 percent (95 percent CI 43, 61) (one-sided p-value 0.0001, statistically significant). The median duration of response (DoR) for participants treated with pembrolizumab was 10.6 months (range 1.1+, 16.5+) and 9.5 months (range 1.4+, 15.4+) for those in the placebo arm.
The adverse response profile reported in Study KEYNOTE-811 individuals receiving pembrolizumab matches the known pembrolizumab safety profile.
Adult patients with locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma should take 200 mg every 3 weeks or 400 mg every 6 weeks of pembrolizumab in conjunction with trastuzumab and chemotherapy.
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