Sumary of FDA grants regular approval to Keytruda-Lenvima combination for endometrial carcinoma:
- Back to Healio The FDA granted regular approval to the combination of pembrolizumab and lenvatinib for certain women with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient.
- The agency had granted accelerated approval to the combination for this indication in September 2019. Continued approval was contingent upon verification and description of clinical benefit.
- The FDA based the approval on results of the randomized phase 3 KEYNOTE-775/Study 309 trial, which included 697 women with advanced endometrial carcinoma previously treated with at least one prior platinum-based chemotherapy regimen who had disease that was not microsatellite instability-high or mismatch repair deficient.
- Researchers randomly assigned 346 women to the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) dosed at 200 mg via IV every 3 weeks plus lenvatinib (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — dosed at 20 mg orally once daily.
- The other 351 women received investigator’s choice of doxorubicin dosed at 60 mg/m2 every 3 weeks (n = 254) or paclitaxel dosed at 80 mg/m2 weekly in a 3-weeks-on, 1-week-off schedule (n = 97).
- Patients assigned the pembrolizumab-lenvatinib combination achieved significantly longer PFS (HR = 0.6;
- The combination also induced a higher objective response rate (30% vs.
- ” Fatal adverse reactions occurred among 4.7% of women assigned the pembrolizumab-lenvatinib combination.