![]() ![]() Treatment was given until disease progression or unacceptable toxicity. Patients were randomized 1:1 to receive oral lenvatinib at 20 mg daily and pembrolizumab at 200 mg intravenously (IV) every 3 weeks (n = 411) or doxorubicin at 60 mg/m 2 IV every 3 weeks or paclitaxel at 80 mg/m 2 IV weekly on a 3-weeks-on/1-week-off schedule (n = 416). In the phase 3 Study-309/KEYNOTE-775 trial, investigators compared the efficacy and safety of pembrolizumab and lenvatinib with physician’s choice of doxorubicin or paclitaxel following platinum-based therapy in patients with advanced or recurrent endometrial cancer. ![]() In prior phase 2 data of the Study 111/KEYNOTE-146 trial, the combination of lenvatinib and pembrolizumab showed efficacy and a manageable safety profile in previously treated patients with advanced/recurrent endometrial carcinoma. Previously, checkpoint inhibitors have shown a benefit in patients with microsatellite instability–high/mismatch repair deficient tumors. There continues to be a high unmet need for effective treatments for patients with advanced/recurrent endometrial cancer, said Makker, adding that there are no standard second-line regimens following platinum-based chemotherapy. “Benefits of PFS and OS were observed across all analyzed subgroups, including histology and number of prior therapies.” “Lenvatinib plus pembrolizumab showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and objective response rate versus treatment of physician’s choice, regardless of MMR status in endometrial cancer following prior platinum-based chemotherapy,” lead study author Vicky Makker, MD, medical oncologist of Memorial Sloan Kettering Cancer Center, said in a virtual presentation of the data. In all-comers, the median PFS was 7.2 months with pembrolizumab/lenvatinib and 3.8 months with chemotherapy (HR, 0.56 95% CI, 0.47-0.66 P <.0001). ![]() Results showed that the median PFS in patients with pMMR status was 6.6 months and 3.8 months with pembrolizumab/lenvatinib and chemotherapy, respectively (HR, 0.60 95% CI, 0.50-0.72 P <.0001). In patients with MMR-proficient (pMMR) disease, the median OS was 17.4 months with pembrolizumab/lenvatinib compared with 12.0 months with chemotherapy at a median follow-up of 11.4 months (HR, 0.68 95% CI, 0.56-0.84 P <.0001). The combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) improved progression-free and overall survival (OS), as well as response rates, compared with chemotherapy in patients with advanced endometrial cancer who received prior platinum-based chemotherapy, irrespective of mismatch repair (MMR) status, according to phase 3 findings of the Study-309/KEYNOTE-775 trial (NCT03517449) that were presented during the 2021 SGO Virtual Annual Meeting on Women’s Cancer. ![]()
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