![]() The median PFS was longer with lenvatinib plus pembrolizumab than with chemotherapy in pMMR population, 6.6 versus 3.8 months (hazard ratio for progression or death 0.60, 95% confidence interval 0.50 to 0.72 p < 0.001) and also in overall population, 7.2 versus 3.8 months (HR 0.56, 95% CI 0.47 to 0.66 p < 0.001). In total, 827 patients of whom 697 with pMMR disease and 130 with mismatch repair–deficient disease were randomly assigned to receive lenvatinib plus pembrolizumab (411 patients) or chemotherapy (416 patients). Patients were randomly assigned in a 1:1 ratio. The endpoints were evaluated in patients with pMMR disease and in all patients. ![]() Two primary endpoints were PFS as assessed on blinded independent central review according to the RECIST v1.1, and OS. The Study 309–KEYNOTE-775 was conducted to confirm the results of that earlier study by comparing the efficacy and safety of lenvatinib plus pembrolizumab with the physician’s choice of doxorubicin or paclitaxel chemotherapy in patients with advanced endometrial cancer who had disease progression after the receipt of at least one platinum-based therapy. High-grade adverse events were managed with supportive therapy and dose modifications, with a relatively low incidence of discontinuation due to adverse events. Previously in a phase II Study 111–KEYNOTE-146, treatment with a multitargeted tyrosine kinase inhibitor of VEGFR1-3, FGFR1-4, PDGFRα, RET, and KIT, lenvatinib in combination with PD-1 inhibitor pembrolizumab had compelling efficacy in patients with previously treated advanced endometrial carcinoma. Vicky Makker of the Memorial Sloan Kettering Cancer Center in New York, NY, US and colleagues on 19 January 2022 in The New England Journal of Medicine. Benefits were seen across all evaluated subgroups. In a phase III Study 309–KEYNOTE-775 treatment with lenvatinib plus pembrolizumab led to significantly longer progression-free survival (PFS) and overall survival (OS) than chemotherapy of the treating physician’s choice, both in the population with mismatch repair–proficient (pMMR) disease and in the overall study population of patients with advanced endometrial cancer who had disease progression after the receipt of previous systemic platinum-based therapy.
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