Phase III KEYNOTE-775/Study 309 trial of Keytruda + Lenvima meets endpoints in endometrial cancer.- Merck Inc and Eisai

Merck Inc and Eisai announced the first presentation of investigational data from the pivotal Phase III KEYNOTE-775/Study 309 trial evaluating the combination of Keytruda (pembrolizumab), from Merck Inc, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting. The study met the dual primary endpoints of progression-free survival (PFS), as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS) as well as the secondary efficacy endpoint of objective response rate (ORR), as assessed by BICR per RECIST v1.1, in the all-comer population (mismatch repair proficient [pMMR] and mismatch repair deficient [dMMR]) and in the pMMR subgroup. Median follow-up was 11.4 months for both the all-comer population and the pMMR subgroup. A statistically significant and clinically meaningful improvement in PFS was seen in the all-comer population, in which Keytruda plus Lenvima (n=411) reduced the risk of disease progression or death by 44% (HR=0.56 [95% CI: 0.47-0.66]; p<0.0001), with a median pfs of 7.2 months (95% ci: 5.7-7.6; number of events="281)" versus 3.8 months (95% ci: 3.6-4.2; number of events="286)" for patients who received chemotherapy (treatment of physician’s choice [tpc] of doxorubicin or paclitaxel; n="416)." additionally, a statistically significant and clinically meaningful improvement in os was seen in the all-comer population, in which keytruda plus lenvima reduced the risk of death by 38% (hr="0.62" [95% ci: 0.51-0.75]; p><0.0001), with a median os of 18.3 months (95% ci: 15.2-20.5; number of events="188)" versus 11.4 months (95% ci: 10.5-12.9; number of events="245)" for patients who received tpc. the safety profile of keytruda plus lenvima was generally consistent with the established safety profiles of the individual monotherapies. data were presented in an oral plenary session (plenary session #10191) at the virtual society of gynecologic oncology (sgo) 2021 annual meeting on women’s cancer.>