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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorPothuri, Bhavana
dc.contributor.authorGilbert, Lucy
dc.contributor.authorBrown, Jubilee
dc.contributor.authorGhamande, Sharad
dc.contributor.authorOAKNIN, ANA
dc.contributor.authorSabatier, Renaud
dc.date.accessioned2023-11-28T07:19:42Z
dc.date.available2023-11-28T07:19:42Z
dc.date.issued2023-11-15
dc.identifier.citationOaknin A, Pothuri B, Gilbert L, Sabatier R, Brown J, Ghamande S, et al. Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study. Clin Cancer Res. 2023 Nov 15;29(22):4564–74.
dc.identifier.issn1557-3265
dc.identifier.urihttps://hdl.handle.net/11351/10663
dc.descriptionEfficacy; Biomarker; Endometrial cancer
dc.description.abstractPurpose: This interim report of the GARNET phase I trial presents efficacy and safety of dostarlimab in patients with advanced or recurrent endometrial cancer (EC), with an analysis of tumor biomarkers as prognostic indicators. Patients and Methods: A total of 153 patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and 161 patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) EC were enrolled and dosed. Patients received 500 mg dostarlimab every 3 weeks for four cycles, then 1,000 mg every 6 weeks until progression. Primary endpoints were objective response rate (ORR) and duration of response (DOR). Results: A total of 143 patients with dMMR/MSI-H EC and 156 patients with MMRp/MSS EC were evaluated for efficacy. ORR was 45.5% (n = 65) and 15.4% (n = 24) for dMMR/MSI-H EC and MMRp/MSS EC, respectively. Median DOR for dMMR/MSI-H EC was not met (median follow-up, 27.6 months); median DOR for MMRp/MSS EC was 19.4 months. The ORRs by combined positive score (CPS) ≥1 status were 54.9% and 21.7% for dMMR/MSI-H EC and MMRp/MSS EC, respectively. ORRs by high tumor mutational burden (≥10 mutations/Mb) were 47.8% (43/90) and 45.5% (5/11) for dMMR/MSI-H EC and MMRp/MSS EC, respectively. ORR in TP53mut or POLεmut molecular subgroups was 18.1% (17/94) and 40.0% (2/5), respectively. The safety profile of dostarlimab was consistent with previous reports. Conclusions: Dostarlimab demonstrated durable antitumor activity and safety in patients with dMMR/MSI-H EC. Biomarkers associated with EC may identify patients likely to respond to dostarlimab.
dc.language.isoeng
dc.publisherAmerican Association for Cancer Research
dc.relation.ispartofseriesClinical Cancer Research;29(22)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectAnticossos monoclonals - Ús terapèutic
dc.subjectAvaluació de resultats (Assistència sanitària)
dc.subjectEndometri - Càncer - Tractament
dc.subject.meshEndometrial Neoplasms
dc.subject.meshAntibodies, Monoclonal, Humanized
dc.subject.meshTreatment Outcome
dc.titleSafety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1158/1078-0432.CCR-22-3915
dc.subject.decsneoplasias endometriales
dc.subject.decsanticuerpos monoclonales humanizados
dc.subject.decsresultado del tratamiento
dc.relation.publishversionhttps://doi.org/10.1158/1078-0432.CCR-22-3915
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Oaknin A] Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Pothuri B] Gynecologic Oncology Group (GOG) and Department of Obstetrics/Gynecology, Laura & Isaac Perlmutter Cancer Center, NYU Langone Health, New York, USA. [Gilbert L] Division of Gynecologic Oncology, McGill University Health Centre, Montreal, Quebec, Canada. [Sabatier R] Department of Medical Oncology, Institut Paoli Calmettes, Aix-Marseille University, Marseille, France. [Brown J] Division of Gynecologic Oncology, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, USA. [Ghamande S] Department of Obstetrics and Gynecology, Georgia Cancer Center, Augusta University, Augusta, Georgia
dc.identifier.pmid37363992
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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