dc.contributor.author | Oaknin, A | |
dc.contributor.author | Pothuri, B | |
dc.contributor.author | Gilbert, L | |
dc.contributor.author | Sabatier, R | |
dc.contributor.author | Brown, J | |
dc.contributor.author | Ghamande, S | |
dc.contributor.author | Mathews, C | |
dc.contributor.author | O'Malley, DM | |
dc.contributor.author | Kristeleit, R | |
dc.contributor.author | Boni, V | |
dc.contributor.author | Gravina, A | |
dc.contributor.author | Banerjee, S | |
dc.contributor.author | Miller, R | |
dc.contributor.author | Pikiel, J | |
dc.contributor.author | Mirza, MR | |
dc.contributor.author | Dewal, N | |
dc.contributor.author | Antony, G | |
dc.contributor.author | Dong, Y | |
dc.contributor.author | Zografos, E | |
dc.contributor.author | Veneris, J | |
dc.contributor.author | Tinker, AV | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-09-18T15:22:31Z | |
dc.date.available | 2023-09-18T15:22:31Z | |
dc.date.issued | 2023-11-14 | |
dc.identifier | 727516 | |
dc.identifier.citation | Clinical Cancer Research, 2023, pp. CCR-22-3915 - | |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5968 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.doi | 10.1158/1078-0432.CCR-22-3915 | |
dc.description.abstract | PURPOSE: 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. See related commentary by Jangra and Dhani, p. 4521. | |
dc.format | Print-Electronic | |
dc.format.extent | CCR-22-3915 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER ASSOC CANCER RESEARCH | |
dc.relation.ispartof | Clinical Cancer Research | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-06-20 | |
dc.date.updated | 2023-09-18T15:22:02Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1158/1078-0432.CCR-22-3915 | |
rioxxterms.licenseref.startdate | 2023-06-26 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37363992 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1158/1078-0432.ccr-22-3915 | |
dc.contributor.icrauthor | Banerjee, Susana | |
icr.provenance | Deposited by Mr Arek Surman on 2023-09-18. Deposit type is initial. No. of files: 1. Files: ccr-22-3915.pdf | |