Merck and Eisai have reported that the Phase 3 LEAP-001 trial for the first-line treatment of patients with advanced or recurrent endometrial carcinoma did not meet its dual primary endpoints. The combination treatment of KEYTRUDA, Merck’s anti-PD-1 therapy, and LENVIMA, Eisai’s orally available multiple receptor tyrosine kinase inhibitor, failed to sufficiently improve overall survival (OS) and progression-free survival (PFS) compared to standard platinum-based chemotherapy in certain patient groups.

The trial specifically looked at patients whose disease was mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H. Despite not reaching these primary endpoints, the safety profile of KEYTRUDA plus LENVIMA was consistent with previous studies.

While the full evaluation of the study data is ongoing, and the findings will be shared with the scientific community, the results were undeniably a setback for Merck and Eisai as they had hoped to offer a new treatment option for newly diagnosed patients with certain types of advanced or recurrent endometrial carcinoma.

Dr. Gregory Lubiniecki from Merck and Dr. Corina Dutcus from Eisai expressed their disappointment but remained confident in the benefits of KEYTRUDA plus LENVIMA for advanced endometrial carcinoma patients who have undergone prior treatment, based on results from the KEYNOTE-775/Study 309 trial. They reiterated their commitment to continuing research on this drug combination for other types of challenging cancers.

Despite these trial results, KEYTRUDA plus LENVIMA retains its approved status in the U.S., the EU, Japan, and other countries for the treatment of specific types of advanced endometrial carcinoma following systemic therapy in any setting, as well as for advanced renal cell carcinoma (RCC), with Lenvatinib marketed as KISPLYX for advanced RCC in the EU.

Merck and Eisai remain dedicated to their LEAP clinical program, investigating the KEYTRUDA plus LENVIMA combination across various tumor types, including hepatocellular carcinoma, RCC, head and neck cancer, gastric cancer, and esophageal cancer in multiple trials. The LEAP-001 trial findings do not impact the approved indications for KEYTRUDA plus LENVIMA or other ongoing studies within the LEAP clinical program.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.