9/16/2023 0 Comments Keynote 775![]() Impact of Lenvatinib-Pembrolizumab on Clinical Practice in Advanced. Safety Results From KEYNOTE-775 Trial in Advanced EC EP: 4. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. Phase 3 KEYNOTE-775 Trial in Advanced Endometrial Cancer EP: 3. Japan endometrial cancer lenvatinib pembrolizumab treatment outcomes. in patients with advanced endometrial cancer: Study 309/KEYNOTE-775. Similar to the global Study 309/KEYNOTE-775 results, this analysis suggested favorable efficacy and manageable safety with lenvatinib plus pembrolizumab after platinum-based chemotherapy in Japanese patients with advanced endometrial cancer and supports this combination as a new standard of care in this population. KEYNOTE-775, Makker V, Colombo N, Herrez AC, Santin A, Colomba E, Miller D, et al. ![]() Adverse events were manageable and led to discontinuation of one/both study drugs in 36.5% of patients in the lenvatinib plus pembrolizumab group versus 7.8% in the TPC group. Hazard ratios for OS were 0.74 (0.41-1.34) with pMMR and 0.59 (0.33-1.04) for all-comers. In KEYNOTE-146 and KEYNOTE-775/Study 309, pembrolizumab/lenvatinib was associated with improved outcomes in all-comers, including those with dMMR endometrial. Hazard ratios (HRs) for PFS with lenvatinib plus pembrolizumab versus TPC were 1.04 (95% CI, 0.63-1.73) in patients with pMMR and 0.81 (0.50-1.31) in all-comers. ![]() One hundred four patients were randomized in Japan (data cutoff, Octomedian follow-up, 11.8 months). Primary endpoints were PFS by blinded independent central review per RECIST version 1.1 and OS. Patients were randomized to oral lenvatinib 20 mg/day plus intravenous pembrolizumab 200 mg every 3 weeks (Q3W up to 35 cycles of pembrolizumab) or TPC (intravenous doxorubicin 60 mg/m 2 Q3W or paclitaxel 80 mg/m 2 QW ). We present results for the Japanese subset. KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant a. ![]() Primary endpoints of superiority for lenvatinib plus pembrolizumab were met for progression-free survival (PFS) and overall survival (OS) in all-comers (ie, regardless of mismatch repair status) and patients with MMR proficiency (pMMR). 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 receiv. Study 309/KEYNOTE-775 is a phase 3 open-label, randomized trial of lenvatinib plus pembrolizumab versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer with progression after platinum-based therapy. PMID: 35045221 (Study 309KEYNOTE-775 Investigators-Study Investigator) Oonk MHM, Slomovitz B, Baldwin PJW, van Doorn HC, van der Velden J, de Hullu JA. ![]()
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