Merck announces results from KEYNOTE-146/Study 111 of KEYTRUDA plus LENVIMA
Merck (MRK) and Eisai announced final results from the full endometrial cancer cohort of KEYNOTE-146/Study 111 evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, an orally available kinase inhibitor discovered by Eisai. The primary endpoint was objective response rate at week 24 as assessed by investigators per immune-related Response Evaluation Criteria in Solid Tumors. KEYNOTE-146/Study 111 supported the U.S. Food and Drug Administration approval for the combination of KEYTRUDA plus LENVIMA for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. In Sept. 2019, the Australian Therapeutic Goods Administration and Health Canada also approved the combination of KEYTRUDA plus LENVIMA for the treatment of advanced endometrial carcinoma. Continued approval for this indication may be contingent in each jurisdiction upon verification and description of clinical benefit in the confirmatory trial.