An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study)
- PMID: 40382973
- DOI: 10.1016/j.ijgc.2025.101903
An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study)
Abstract
Objective: Patients with advanced or recurrent endometrial cancer who experience progression following platinum-based chemotherapy have limited treatment options. The phase I GARNET trial showed the high efficacy of dostarlimab in treating mismatch repair deficient (dMMR) and/or microsatellite instability-high (MSI-H) endometrial cancer.
Methods: DORA is a multi-center, ambispective, observational real-world study evaluating the efficacy and safety of dostarlimab. The study included patients with dMMR/MSI-H endometrial cancer who had experienced tumor progression on or after a platinum-based treatment and had received at least 1 cycle of dostarlimab within the Spanish Expanded Access Program. The primary endpoints were objective response rate and duration of response.
Results: A total of 129 patients from 57 of the Spanish Research Group for Gynaecological Cancer (GEICO) affiliated hospitals were enrolled, with 125 evaluable for radiological response. The median duration of dostarlimab administration was 8.8 months (interquartile range; 13.2), and 73 patients (57%) remained on therapy at the data cutoff. With a median follow-up of 11.6 months (range; 0.8-30.1), the objective response rate was 53.6% (95% CI 44.4 to 62.5). Complete response was observed in 27 patients (21.6%), and partial response in 40 (32%), with a median time to response of 2.9 months (95% CI 2.6 to 3.6). The median duration of response was not reached. The probability of maintaining the response at 12 and 24 months was 84.98% (95% CI 70.8 to 92.5) and 73.39% (95% CI 50.5 to 86.9), respectively. Treatment was discontinued due to toxicity in 4.7% of patients.
Conclusions: Dostarlimab monotherapy in dMMR/MSI-H endometrial cancer patients shows similar efficacy in real-world practice to that observed in the GARNET trial.
Keywords: Dostarlimab; Endometrial Cancer; Immunotherapy; Microsatellite Instability; Mismatch Repair Deficiency.
Copyright © 2025 European Society of Gynaecological Oncology and the International Gynecologic Cancer Society. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of Competing Interests AG reports receiving honoraria or consultation fees from GSK, MSD, AstraZeneca, Clovis, participation in a company-sponsored speaker’s bureau for Roche, AstraZeneca, MSD, Clovis, and GSK, and travel/accommodation/expenses from Roche, MSD, GSK, AstraZeneca, and PharmaMar. AM has received support for attending meetings and/or travel from AstraZeneca, GSK, and MSD. She has also received payment or honoraria from AstraZeneca, GSK, MSD, Pharma&, and PharmaMar. Given her role as Editorial Board Member, AM had no involvement in the peer review of this article and has no access to information regarding its peer review. PEG reports having received honoraria from MSD, AstraZeneca, Eisai, and GSK, research grant/funding to her institution from GSK, and travel/accommodation/expenses from MSD, AstraZeneca, GSK, PharmaMar, and Pharma& outside the submitted work. IP has received support for attending meetings and/or travel from GSK and MSD, and payment or honoraria from AstraZeneca, MSD, and Eisai. CC has received support for attending meetings and/or travel from Roche, AstraZeneca, PharmaMar, Clovis, MSD, and GSK. She has also received payment or honoraria for speakers bureaus, manuscript writing, and educational events from Roche, Astra-Zeneca, PharmaMar, Clovis, MSD, and GSK. She participated in an advisory board for GSK. FG reports receiving support for attending meetings and/or travel from Roche, AstraZeneca, PharmaMar, Pharma&, Clovis, MSD, and GSK. He also participated in an advisory board for AstraZeneca, Clovis, PharmaMar, and GSK. MEO has received support for attending meetings and/or travel from AstraZeneca, PharmaMar, Clovis, MSD, Merck, Eisai, and GSK. She has also received payment or honoraria for presentations, speakers bureaus, and educational events from Merck, AstraZeneca, PharmaMar, Clovis, MSD, Eisai, and GSK, and has participated in advisory boards for GSK and Eisai. MM has received support for attending meetings and/or travel from AstraZeneca, Clovis, MSD, and GSK. CML has received support for attending meetings and/or travel from AstraZeneca, Clovis, GSK, and MSD. She has received payment or honoraria for speakers bureaus, manuscript writing, and educational events from AstraZeneca, Clovis, GSK, MSD, PharmaMar, and Pharma&. She participated in advisory boards for Clovis and GSK. BH has received support for attending meetings and/or travel from Daiichi-Sankyo, AstraZeneca, GSK, and MSD. JFC reports honoraria from GSK, MSD, AstraZeneca, PharmaMar, and Clovis, and travel/accommodations support from AstraZeneca, GSK, Clovis, PharmaMar, and MSD, outside this submitted work. DGI has received support for attending meetings and/or travel from AstraZeneca, GSK, and MSD. He has also received payment or honoraria from GSK. MME reports having received honoraria from MSD, AstraZeneca, and GSK, research grant/funding to her institution from Eisai and PharmaMar, and travel/accommodation/expenses from Biocartis, AstraZeneca, GSK, PharmaMar, Roche, and Pfizer outside the submitted work. AR reports administrative support, article publishing charges, statistical analysis, and writing assistance were provided by Grupo Español de Investigación en Cáncer Ginecológico. AR reports receiving honoraria from and providing advisory/consultancy services for MSD, AstraZeneca, GSK, PharmaMar, Roche, Pharma&, and Boehringer Ingelheim, travel/accommodation/expenses from AstraZeneca, GSK, PharmaMar, and Roche, and participating in a speaker’s bureau for MSD, AstraZeneca, GSK, PharmaMar, and Pharma& outside the submitted work. The following authors declare no competing interests: FA, AC, PM, AMA, IL, and EG.
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