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# Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer
- URL: https://www.fdaweb.com/keytruda-lenvima-mixed-data-in-gastroesophageal-cancer/
- Published: 2025-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:51:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158545

Merck and Eisai are announcing disappointing results from the Phase 3 LEAP-015 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor-negative gastroesophageal adenocarcinoma. The companies’ final analysis found that the trial did not meet its primary endpoint of overall survival. However, an earlier interim analysis found that Keytruda plus Lenvima demonstrated a statistically significant improvement in the other primary endpoint, progression-free survival, and objective response rate, a key secondary endpoint, compared to standard-of-care chemotherapy.

The companies say the safety profile of Keytruda plus Lenvima was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data is ongoing, and it will be presented at an upcoming medical meeting.