- KEYTRUDA plus LENVIMA shows a 16.7% 5-year survival rate in pMMR advanced endometrial carcinoma versus 7.3% for chemotherapy.
- The Phase 3 KEYNOTE-775/Study 309 trial involved 827 patients, with 411 receiving KEYTRUDA plus LENVIMA.
- The trial's primary endpoints were overall survival (OS) and progression-free survival (PFS).
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.
