Merck and Eisai: KEYTRUDA and LENVIMA Show 5-Year Survival Benefit in Advanced Endometrial Carcinoma

Study Overview

The Phase 3 KEYNOTE-775/Study 309 trial evaluated the efficacy of KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) versus chemotherapy in patients with advanced endometrial carcinoma. The trial included 827 patients, with 411 receiving the combination therapy and 416 receiving chemotherapy.

Survival Rates

At five years, the overall survival (OS) rate for patients with mismatch repair proficient (pMMR) advanced endometrial carcinoma was 16.7% with KEYTRUDA plus LENVIMA, compared to 7.3% for chemotherapy. In the all-comers population, the OS rate was 19.9% for the combination therapy versus 7.7% for chemotherapy.

Progression-Free Survival

The five-year progression-free survival (PFS) rate in the pMMR subgroup was 6.3% for KEYTRUDA plus LENVIMA, compared to 2.1% for chemotherapy. In the all-comers population, the PFS rate was 9.8% for the combination therapy versus 3.2% for chemotherapy.

Adverse Events

Treatment-related adverse events occurred in 97.3% of patients receiving KEYTRUDA plus LENVIMA, leading to discontinuation in 40.1% of cases. Common adverse events included hypertension, hypothyroidism, and diarrhea.

Regulatory Approvals

Based on the primary analysis results, KEYTRUDA plus LENVIMA is approved in the U.S. for patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H) following prior systemic therapy. The combination is also approved in the EU and Japan for certain patients with advanced or recurrent endometrial carcinoma.