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#Keynote 775 full#
For full disclosures of the study authors, visit. Makker, of Memorial Sloan Kettering Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.ĭisclosure: The study was supported by Eisai Inc and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc.
#Keynote 775 plus#
The investigators concluded, “Lenvatinib plus pembrolizumab continued to show improved efficacy vs chemotherapy and manageable safety in patients with previously treated advanced endometrial cancer.”ĭr. No new safety signals were observed during extended follow-up. Overall survival, progression-free survival, and objective response rate favored lenvatinib/pembrolizumab in all subgroups of interest. In the total population, objective response was observed in 33.8% v 14.7%, with median response durations of 12.9 vs 5.7 months. In the pMMR population, objective response was observed in 32.4% vs 15.1% of patients, with median response durations of 9.3 vs 5.7 months. In the total population, median progression-free survival was 7.3 months (95% CI = 5.7–7.6 months) in the lenvatinib/pembrolizumab group vs 3.8 months (95% CI = 3.6–4.2 months) in the chemotherapy group (HR = 0.56, 95% CI = 0.48–0.66).
In the pMMR population, median progression-free survival was 6.7 months (95% CI = 5.6–7.4 months) in the lenvatinib/pembrolizumab group vs 3.8 months (95% CI = 3.6–5.0 months) in the chemotherapy group (HR = 0.60, 95% CI = 0.50–0.72). In KEYNOTE-146 and KEYNOTE-775/Study 309, pembrolizumab/lenvatinib was associated with improved outcomes in all-comers, including those with dMMR endometrial. In the total population, median overall survival was 18.7 months (95% CI = 15.6–21.3 months) in the lenvatinib/pembrolizumab group vs 11.9 months (95% CI = 10.7–13.3 months) in the chemotherapy group (HR = 0.65, 95% CI = 0.55–0.77). Introduction/Background In the phase 3 Study 309/KEYNOTE-775 (Makker 2022, NEJM), lenvatinib plus pembrolizumab (L+P) demonstrated statistically and. In the pMMR population, median overall survival was 18.0 months (95% confidence interval = 14.9–20.5 months) in the lenvatinib/pembrolizumab group vs 12.2 months (95% CI = 11.0–14.1 months) in the chemotherapy group (hazard ratio = 0.70, 95% CI = 0.58–0.83). The updated analysis included the final prespecified analysis for overall survival.Īs of data cutoff (in March 2022, > 16 months of additional follow-up from the primary analysis), median follow-up was 18.7 months in the lenvatinib/pembrolizumab group and 12.2 months in the chemotherapy group. A total of 346 patients in the lenvatinib/pembrolizumab group and 351 in the chemotherapy group had pMMR disease. In the international open-label trial, 827 patients with advanced, recurrent, or metastatic disease were randomly assigned to receive lenvatinib at 20 mg once daily plus pembrolizumab at 200 mg once every 3 weeks (n = 411) or chemotherapy of physician’s choice (n = 416), consisting of doxorubicin at 60 mg/m 2 once every 3 weeks or paclitaxel at 80 mg/m 2 once weekly for 3 weeks on/1 week off.
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