Based on findings from the KEYNOTE-811 trial, the FDA approved Keytruda for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in combination with trastuzumab and chemotherapy.
The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for use with trastuzumab, fluoropyrimidine-and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
This accelerated approval was based on an analysis of 264 patients with HER2-positive advanced gastric or GEJ adenocarcinoma from the ongoing KEYNOTE-811 trial, according to a release from the FDA. In this trial, patients were not previously treated with systemic therapy for metastatic disease. Patients were assigned either 200 milligrams of Keytruda or placebo every three weeks. Both groups also received trastuzumab and either Xeloda (capecitabine) plus Eloxatin (oxaliplatin) or fluorouracil plus cisplatin.
The overall response rate (or the percentage of patients with partial or complete response to a therapy) was 74% in patients assigned Keytruda compared with 52% in those assigned placebo. In addition, Patients in the Keytruda group had a longer median duration of response compared with those in the placebo group (10.6 months versus 9.5 months. The side effect profile in patients treated with Keytruda was consistent with what has already been established with this particular drug, according to the release.
The recommended dose of Keytruda for adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in addition to trastuzumab and chemotherapy, is either 200 milligrams every three weeks or 400 milligrams every six weeks.
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