Pembrolizumab regimen fails to hit EFS target in gastric, gastroesophageal junction cancer
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The addition of pembrolizumab to perioperative chemotherapy failed to significantly extend EFS among patients with locally advanced resectable gastric and gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.
The result of the randomized phase 3 KEYNOTE-585 trial “underscores the challenges in treating locally advanced resectable gastric cancer,” Scot Ebbinghaus, MD, vice president of global clinical development at Merck Research Laboratories, said in a Merck press release.
“Innovative research in earlier stages of cancer is critical to help patients achieve better outcomes, and our efforts continue in earnest,” he said. “We are grateful to the patients and investigators for their participation in this study.”
KEYNOTE-585 assessed pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, in combination with both neoadjuvant and adjuvant chemotherapy, followed by pembrolizumab as monotherapy. Chemotherapy consisted of cisplatin plus capecitabine plus 5-FU.
The trial enrolled 1,007 patients randomly assigned in a 1:1 ratio to either pembrolizumab or placebo and the chemotherapy regimen, followed by either pembrolizumab or placebo.
EFS, pathologic complete response rate and OS served as the primary endpoints. Secondary endpoints included DFS and safety.
Results of a prespecified interim analysis performed by an independent data monitoring committee showed statistically significant improvement in pathologic complete response rates with the pembrolizumab vs. placebo regimen. Data also showed an increase in EFS in the pembrolizumab group; however, this did not achieve statistical significance per the prespecified statistical analysis plan, according to Merck.
Researchers did not formally test OS because EFS superiority was not reached. The safety profile of pembrolizumab appeared consistent with that reported in earlier studies.
Data will be presented at a future medical meeting, according to Merck.
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