FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer

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On February 9th, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly for adult patients with recurrent or advanced endometrial cancer (EC) with mismatch repair deficiency (dMMR) determined by an FDA-approved test, that has progressed or recurred on a platinum-containing regimen and not amenable to curative surgery or radiation.


Study ID number: NCT02715284


Approval was based on the GARNET trial, a multi-center, single-arm, open-label, phase I study evaluating the anti-programmed death receptor 1 (anti-PD-1) humanized monoclonal antibody dostarlimab (also known as TSR-042) in participants with advanced solid tumors with limited available treatment options. 264 patients with EC were included in the efficacy population, divided into two cohorts, A1 with dMMR/MSI-H disease (108 patients); and A2 with pMMR/MSS disease (156 patients).


The first through fourth doses were 500 mg of intravenous infusion of dostarlimab-gxly given over 30 minutes every 3 weeks. After completion of 4 cycles, patients received 1000mg infusion every 6 weeks until disease progression or unacceptable toxicity.


Major efficacy outcomes were overall response rate (ORR) and duration of response (DOR).


When assessed by blinded independent central review, ORR of 43.5% (95% CI: 34.0%, 53.4%), with 11 complete responses and 36 partial responses was observed after a median follow-up duration of 16.3 months in cohort A1 as compared to ORR of 14.1% (95% CI: 9.1%, 20.6%) with 3 complete responses and 19 partial responses in cohort A2. Median DOR was not reached in either cohort. 85.9% of the patients had DOR of >12 months and 54.7% of the patients had DOR of >24 months.


The most common side effects included fatigue, anemia, rash, nausea, vomiting, constipation, and diarrhea. Immune-mediated adverse effects including pneumonitis, colitis, hepatitis, and endocrinopathies among others were also noted infrequently.


Thus, dostarlimab demonstrated durable efficacy in both cohorts but predominantly in patients with dMMR disease.



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