![]() In the present analysis, exploratory end points included PFS, OS, ORR, duration of response (DOR), and safety. The study comprised 660 patients with pMMR tumors and 120 patients with dMMR tumors. In the trial, patients with advanced, metastatic, or recurrent endometrial cancer with measurable disease following platinum-based chemotherapy were randomized to 20 mg of oral lenvatinib once daily plus 200 mg of intravenous (IV) pembrolizumab every 3 weeks, or 60 mg/m2 of IV doxorubicin every 3 weeks or 80 mg/m2 of IV paclitaxel for 3 consecutive weeks followed by 1 week off. To better understand the effects of the combination in this population, investigators evaluated the outcomes of patients with MSI-H/dMMR tumors enrolled in KEYNOTE-775. ![]() However, around 16% to 31% of endometrial cancers are MSI-H/dMMR. On July 21, 2021, the FDA granted a full approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation based on data from the KEYNOTE-775 trial. In prior findings from the KEYNOTE-775 trial, pembrolizumab plus lenvatinib led to a statistically significant improvement in OS, PFS, and objective response rate (ORR) vs physician’s choice of treatment in mismatch repair proficient (pMMR) and all-comer populations with advanced endometrial cancer following platinum-based chemotherapy. However, checkpoint inhibitors have shown benefit in patients with microsatellite instability–high (MSI-H) and dMMR tumors. There is no standard second-line therapy for patients with advanced endometrial cancer following platinum-based chemotherapy, creating a high unmet need for effective treatments. “Efficacy in the dMMR population of patients with advanced endometrial cancer appeared to improve with pembrolizumab plus lenvatinib, at least consistent with that of patients in both the pMMR and all-comers populations previously reported,” lead study author Vicky Makker, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, said in a virtual presentation of the data. ![]() In the dMMR cohort, the median OS was not reached ( 95% CI, NR-NR) in the pembrolizumab/lenvatinib arm (n = 65) vs 8.6 months (95% CI, 5.5-12.9) in the physician’s choice of treatment arm (n = 65 HR, 0.37 95% CI, 0.22-0.62 P <.0001). The combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) led to a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) in patients with mismatch repair deficient (dMMR) advanced endometrial cancer following platinum-based chemotherapy, according to findings from a prespecified exploratory analysis of the phase 3 KEYNOTE-775 trial (NCT03517449) that was presented during the 2021 International Gynecologic Cancer Society Annual Global Meeting. ![]()
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