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Pembrolizumab Improves Response in HER2-Positive Gastric Cancer
Standard treatment of advanced HER2-positive esophagogastric cancer combines trastuzumab with fluorinated pyrimidine/platinum-based chemotherapy. Investigators now report a planned interim analysis of response rates in the industry-sponsored, international, phase 3 KEYNOTE-811 trial in which patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma were randomized to treatment with either pembrolizumab (200 mg every 3 weeks) or placebo along with trastuzumab and investigator's choice of capecitabine/oxaliplatin or infusional 5-FU/cisplatin.
Of 433 patients randomized, 81% were male, 68% had gastric primary tumors, 81% were immunohistochemistry positive at 3+ for HER2, and 84% were PD-L1–positive at ≥1%. In this interim efficacy analysis of 264 patients, the pembrolizumab arm had a significantly higher response rate compared with placebo (74.4% vs. 51.9%; P=0.00006), deeper response (change from baseline, 65% vs. 49%), higher rate of complete response (11.3% vs. 3.1%), and higher rate of disease control (96.2% vs. 89.3%). Patients with a combined positive score (CPS) <1% had a smaller incremental increase in response with pembrolizumab than those with a CPS ≥1% (4.6% vs. 25.2%). Median response duration was similar with pembrolizumab and placebo (10.6 and 9.5 months). No new safety signals were observed.
Based on this interim analysis indicating superior response for treatment with pembrolizumab combined with trastuzumab and chemotherapy in patients with HER2-positive gastric or gastroesophageal junction cancer, the FDA recently approved use of pembrolizumab. Reporting of the full KEYNOTE-811 trial results, including rates of progression-free and overall survival, is pending.
Janjigian YY et al.
Title: The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer.
Source: Nature 2021 Dec ; [e-pub]. (Abstract/FREE Full Text)