Pembrolizumab regimen extends OS in metastatic gastric, gastroesophageal junction cancers
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The addition of pembrolizumab to chemotherapy improved OS among certain patients with gastric or gastroesophageal junction cancers, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) is an anti-PD-1 therapy.
The randomized phase 3 KEYNOTE-859 trial evaluated the efficacy of chemotherapy plus pembrolizumab or placebo as first-line treatment for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma.
Researchers randomly assigned 1,579 patients to fluoropyrimidine- and platinum-containing chemotherapy plus either 200 mg pembrolizumab every 3 weeks — administered for up to 2 years — or placebo.
Results showed a statistically significant improvement in OS — the study’s primary endpoint — with the pembrolizumab regimen. The study also met secondary endpoints, showing improved PFS and overall response rate with pembrolizumab.
“Despite improvements in cancer care, advanced gastric cancer continues to have one of the lowest 5-year survival rates, and new interventions are urgently needed. The results from KEYNOTE-859 show the potential of Keytruda plus chemotherapy to improve survival beyond chemotherapy alone for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression,” Eliav Barr, MD, senior vice president and head of global clinical development and chief medical officer for Merck Research Laboratories, said in a company-issued press release.
Pembrolizumab exhibited a safety profile in KEYNOTE-859 consistent with that observed in previous studies. Researchers identified no new safety signals.
Complete results from the trial will be presented at a medical meeting.
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