![]() ![]() ![]() The phase 1/2 IMMU-132-01 basket study reported clinical activity with SG in patients with multiple tumor types not selected for Trop-2 expression including NSCLC (objective response rate : 17%), TNBC (ORR: 33%), and UC (ORR: 31%).1-3 Results from the overall safety population (N=420) from this study found that SG was tolerable, with a predictable and manageable safety profile, and low discontinuation rates due to AEs. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit these accelerated approval requirements have been fulfilled with the data from Study 309/KEYNOTE-775. SG is a Trop-2–directed antibody drug conjugate containing SN-38 (active metabolite of irinotecan) with a 7.5:1 drug-to-antibody ratio and unique hydrolyzable linker that allows for extracellular bystander effect. not candidates for curative surgery or radiation based on data from the Study 111/KEYNOTE-146 trial. Trophoblast cell surface antigen (Trop-2) is highly expressed in many epithelial cancers (non–small-cell lung cancer, endometrial cancer, urothelial carcinoma, and triple-negative breast cancer ) and has been linked to aggressive disease and poor prognosis. E7080-G000-307 KEYNOTE-581 ( Other Identifier: Merck ) 2016-000916-14 ( EudraCT Number ) First Posted: JKey Record Dates: Results First Posted: September 24, 2021: Last Update Posted: JLast Verified: June 2022 Layout. The sNDA for pembrolizumab plus lenvatinib as treatment of advanced endometrial carcinoma was supported by data from the phase 3 Study-309/KEYNOTE-775 trial (NCT03517449). Serious adverse reactions occurred in 50 of these patients the most common. 2020 ASCO Virtual Scientific Program - Poster Session TROPiCS–03: A phase II open-label study of sacituzumab govitecan (SG) in patients with metastatic solid tumors. In KEYNOTE-775, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced endometrial carcinoma that were not MSI-H or dMMR (n342), fatal adverse reactions occurred in 4.7 of patients. Introduction/Background In the phase 3 Study 309/KEYNOTE-775 (Makker 2022, NEJM), lenvatinib plus pembrolizumab (L+P) demonstrated statistically and. Study 309/KEYNOTE-775 Trial Design (Plenary Session 10191) Study 309/KEYNOTE-775 is a multicenter, randomized, open-label, Phase 3 trial (, NCT03517449) evaluating LENVIMA in combination with KEYTRUDA in patients with advanced endometrial cancer following one prior platinum-based regimen in any setting. ![]()
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