Keytruda and Lenvima trial fails to show OS benefit

Results have been announced from a Phase III trial of Merck & Co’s (NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab) plus Lenvima (lenvatinib), Eisai’s (TYO: 4523) orally available multiple receptor tyrosine kinase inhibitor (TKI), alongside chemotherapy, as a first-line treatment of locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma.

The LEAP-015 study did not show a statistically-significant increase in overall survival, though there was an improvement in progression-free survival, the trial’s other dual primary endpoint, and objective response rate, a key secondary endpoint, for patients treated with Keytruda plus Lenvima in combination with chemotherapy, compared to standard of care chemotherapy.

Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories, said: “Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma remains a challenging disease to treat and a leading cause of cancer death worldwide.