Merck' Keytruda Plus Eisai's Lenvima Cuts Risk Of Death By 38% In Endometrial Cancer Trial Compared To Chemo

Merck & Co MRK has announced data from Phase 3 KEYNOTE-775/Study 309 trial evaluating Keytruda combined with Eisai Co Ltd's ESALY Lenvima for advanced, metastatic, or recurrent endometrial cancer following one prior platinum-based regimen in any setting.

• The data were presented at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer. 
• A statistically significant and clinically meaningful improvement in PFS was seen in the all-comer population. Keytruda plus Lenvima reduced the risk of disease progression or death by 44%, with a median PFS of 7.2 months versus 3.8 months for patients who received chemotherapy.
• Keytruda plus Lenvima reduced the risk of death by 38%, with a median OS of 18.3 months versus 11.4 months in patients who received physician's choice chemotherapy.
• In the all-comer population, the objective response rate was 31.9%, with a complete response (CR) rate of 6.6% and a partial response (PR) rate of 25.3%, in Keytruda plus Lenvima group, versus 14.7%, with a CR rate of 2.6% and a PR rate of 12.0% in the chemo group.
• For patients who responded, the median duration of response (DOR) was 14.4 months for patients in the Keytruda plus Lenvima arm versus 5.7 months in the chemotherapy arm.
• KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the FDA 2019 accelerated approval of Keytruda plus Lenvima 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.
• Price Action: MRK shares are trading 0.43% higher at $77.6 in the premarket on the last check Friday.