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A regimen of pembrolizumab plus trastuzumab and chemotherapy extended OS for individuals with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
The regimen — currently being evaluated in the randomized phase 3 KEYNOTE-811 study — has met its dual primary endpoint by conferring “statistically significant and clinically meaningful improvement in OS compared with placebo” during the final analysis of the trial data, according to a topline data press release from the manufacturer.
Topline results from phase 3 study show pembrolizumab plus trastuzumab and chemotherapy extended OS in certain patients with gastric cancer.
“Patients diagnosed with advanced gastric cancer often face a poor prognosis, underscoring the need for treatment options that have the potential to extend patients’ lives,” Marjorie Green, MD, senior vice president and head of global oncology clinical development at Merck Research Laboratories, said in the release. “These overall survival results from KEYNOTE-811 are encouraging and build on the positive progression-free survival, overall response rate and duration of response data from this study.”
As Healio previously reported, results of an interim analysis from the study presented at last year’s ESMO Annual Congress showed the pembrolizumab-led regimen met its other primary endpoint by conferring significant improvement if PFS compared with placebo.
The addition of the anti-PD-1 antibody pembrolizumab (Keytruda, Merck) to first-line therapy with trastuzumab (Herceptin, Genentech) and fluoropyrimidine- and platinum-containing chemotherapy already received accelerated approval from the FDA in 2021 for previously untreated locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. FDA updated the indication last year to restrict its use to adults whose tumors express PD-L1 (combined positive score 1 or higher) as shown by an FDA-approved test.
FDA initially approved the indication based on objective response rate results and has made full approval contingent on verification of clinical benefits during a final analysis of the trial, according to the release.
