The FDA has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression.
The U.S. Food and Drug Administration (FDA) has granted traditional approval to treatment with Keytruda (pembrolizumab) plus Herceptin (trastuzumab) and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced, unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (combined positive score [CPS] of 1 or more).
According to an announcement from the regulatory agency on their official website, fda.gov, this approval based on the KEYNOTE-811 study, which evaluated the efficacy of Keytruda in combination with Herceptin and chemotherapy. The study enrolled 698 patients with HER2-positive advanced gastric or GEJ adenocarcinoma, none of whom had been previously treated with systemic therapy for metastatic disease. Of the 698 patients, 594 (85%) had tumors expressing PD-L1 with a CPS of 1 or more.
Moreover, Keytruda received accelerated approval status from the regulatory agency for this patient population on May 5, 2021, based on an interim analysis of the KEYNOTE-811 trial.
In patients with tumors that had PD-L1 CPS greater than or equal to 1, the median progression-free survival was 10.9 months in the Keytruda arm and 7.3 months in the placebo arm. The median overall survival was 20.1 months and 15.7 months in these respective arms. The overall response rate was 73% and 58%, while median duration of response was 11.3 months and 9.6 months.
The side effect profile for Keytruda was consistent with its known safety profile.
The recommended dose for Keytruda is 200 milligrams (mg) every three weeks or 400 mg every six weeks, in combination with Herceptin and chemotherapy.
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