No deaths were attributable to dostarlimab.ĭostarlimab demonstrated durable antitumor activity in both dMMR/MSI-H (ORR 43.5%) and MMRp/MSS EC (ORR 14.1%) with a manageable safety profile.Ĭlinical trials as topic immunotherapy programmed cell death 1 receptor. Grade≥3 TRAEs occurred in 16.6% of patients, and 5.5% discontinued dostarlimab because of TRAEs. In the combined cohorts, the majority of treatment-related adverse events (TRAEs) were grade 1-2 (75.5%), most commonly fatigue (17.6%), diarrhea (13.8%), and nausea (13.8%). Median DOR was not reached in either cohort. In cohort A2, ORR was 14.1% (95% CI 9.1% to 20.6%) with three complete responses and 19 partial responses. In cohort A1, ORR was 43.5% (95% CI 34.0% to 53.4%) with 11 complete responses and 36 partial responses. The median follow-up duration was 16.3 months (IQR 9.5-22.1) for cohort A1 and 11.5 months (IQR 11.0-25.1) for cohort A2. Screening began on April 10, 2017, and 129 and 161 patients with advanced EC were enrolled in cohorts A1 and A2, respectively. The primary endpoints were objective response rate (ORR) and duration of response (DOR) per RECIST V.1.1, as assessed by blinded independent central review. Patients received dostarlimab 500 mg every 3 weeks for 4 cycles, then dostarlimab 1000 mg every 6 weeks until disease progression. Two cohorts of patients with EC were recruited: those with dMMR/MSI-H disease (cohort A1) and those with proficient/stable (MMRp/MSS) disease (cohort A2). GARNET, an ongoing, single-arm, open-label, phase I trial of intravenous dostarlimab in advanced solid tumors, is being undertaken at 123 sites. We report interim data from patients with endometrial cancer (EC) participating in a phase I trial of single-agent dostarlimab. 17 Department of Obstetrics and Gynecology, NYU Langone Health, Perlmutter Cancer Center, New York University, New York, New York, USA.ĭostarlimab is a humanized monoclonal antibody that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.16 GlaxoSmithKline, Waltham, Massachusetts, USA.15 O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama, USA.14 Department of Oncology, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK. 13 Department of Gynecological Oncology, University of Calgary, Calgary, Alberta, Canada.12 Georgia Cancer Center, Augusta University, Augusta, Georgia, USA.11 Department of Gynecological Oncology, Emily Couric Clinical Cancer Center, University of Virginia, Charlottesville, Virginia, USA.
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