![]() The objective response rate (ORR) was also improved with pembrolizumab/lenvatinib at 30.3% (95% CI, 25.5%-35.5%), comprised of 5.2% complete responses and 25.1% partial responses, compared with 15.1% (95% CI, 11.5%-19.3%), made up of 2.6% complete responses and 12.5% partial responses. In patients with mismatch repair deficiency who were treated in KEYNOTE-775, statistically significant and clinically meaningful benefits to PFS were observed (HR, 0.60 95% CI, 0.50-0.72 P <.0001), with medians of 6.6 months (95% CI, 5.6-7.4) and 3.8 months (95% CI, 3.6-5.0) with pembrolizumab/lenvatinib and the control therapy, respectively. ![]() ![]() “This approval is an important step forward in helping patients fight this difficult-to-treat malignancy, as physicians can now provide an option that may improve survival outcomes.” “With a five-year survival rate of just 17%, women with advanced endometrial cancer who are not candidates for curative therapy, particularly those with disease progression following prior systemic therapy, have limited treatment options,” Vicky Makker, MD, principal investigator and medical oncologist, Memorial Sloan Kettering Cancer Center, said in a press release. This approval was granted based on results of the phase 3 KEYNOTE-775/Study 309 trial (NCT03517449) which demonstrated improved overall survival (OS) and progression-free survival (PFS) vs physician’s choice of chemotherapy in an all-comer population of patients with advanced, metastatic, or recurrent endometrial cancer who had previously received 1 prior platinum-based regimen in any setting. The FDA granted approval to the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) for the treatment of patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial cancer who have progressed on prior systemic therapies and for whom surgery or radiation are not suitable treatment options.
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