Results from the pivotal phase III KEYNOTE-775/Study 309 trial, evaluating the combination of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting, showed the combination led to significantly longer progression-free survival and overall survival.
The results were published in New England Journal of Medicine.
Keytruda, an anti-PD-1 therapy, is sponsored by Merck. Lenvima, an orally available multiple receptor tyrosine kinase inhibitor, is sponsored by Eisai.
The publication includes previously reported data that was first presented in an oral plenary session at the virtual Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer.
Results showed that the Keytruda plus Lenvima combination demonstrated statistically significant improvements in the dual primary endpoints of OS and PFS compared to chemotherapy. Objective response rate data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.
The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which Keytruda plus Lenvima is not approved in the U.S.
According to the study, the median PFS was longer with Keytruda plus Lenvima than with chemotherapy (pMMR population: 6.6 vs. 3.8 months; HR for progression or death: 0.60; 95% CI: 0.50-0.72; P<0.001; overall: 7.2 vs. 3.8 months; HR: 0.56; 95% CI: 0.47-0.66; P<0.001).
The median OS was longer with Keytruda plus Lenvima than with chemotherapy (pMMR population: 17.4 vs. 12.0 months; HR for death: 0.68; 95% CI: 0.56-0.84; P<0.001; overall: 18.3 vs. 11.4 months; HR: 0.62; 95% CI: 0.51 to 0.75; P<0.001).
Based on the results from the phase III KEYNOTE-775/Study 309 trial, Keytruda plus Lenvima has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation (The Cancer Letter, July 23, 2021).
The combination is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status (The Cancer Letter, Dec. 3, 2021).
Merck and Eisai are studying the Keytruda plus Lenvima combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.
