Lenvima + Keytruda demonstrated in KEYNOTE-755 phase III study statistically significant improvement in OS, PFS and ORR v. chemotherapy in advanced endometrial cancer. Merck Inc. + Eisai

Eisai Co., Ltd. and Merck & Co., announced that the pivotal Phase III Study 309/KEYNOTE-775 trial evaluating the investigational use of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck & Co., Inc., met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, Lenvima plus Keytruda demonstrated a statistically significant and clinically meaningful improvement in OS, PFS and ORR versus chemotherapy (treatment of physician’s choice [TPC] of doxorubicin or paclitaxel). The safety profile of the Lenvima plus Keytruda combination was consistent with previously reported studies. Eisai and Merck & Co., Inc.,will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, and plan to present these results at an upcoming medical meeting. Study 309/KEYNOTE-775 is the confirmatory trial for Study 111/KEYNOTE-146, which supported the FDA 2019 accelerated approval of the Lenvima plus Keytruda combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This accelerated approval was based on tumor response rate and durability of response and was the first approval granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Under Project Orbis, Health Canada and Australia’s Therapeutic Goods Administration (TGA) granted conditional and provisional approvals, respectively, for this indication.