Dostarlimab-gxly receives accelerated approval from the FDA for dMMR endometrial cancer

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August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) received accelerated approval from the Food and Drug Administration for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or after a prior platinum-containing regimen.

In the GARNET Trial (NCT02715284), a multicenter, multicohort, open-label trial in patients with advanced solid tumours, efficacy was assessed depending on cohort (A1). 71 patients with dMMR recurrent or advanced endometrial cancer who progressed on or after a platinum-containing treatment were included in the efficacy population. Patients were given 500 mg of dostarlimab-gxly intravenously every three weeks for four doses, then 1,000 mg intravenously every six weeks.

Overall response rate (ORR) and duration of response (DOR) were the primary efficacy outcomes, as determined by a blinded independent central review (BICR) in accordance with RECIST 1.1. The ORR was confirmed to be 42.3 percent (95 percent CI: 30.6 percent , 54.6 percent ). The response rate was 12.7 percent for complete responses and 29.6 percent for incomplete responses. With 93.3 percent of patients having durations of less than six months, the median DOR was not met (range: 2.6 to 22.4 months, ongoing at last assessment).

In 34 percent of individuals who received dostarlimab-gxly, serious side effects occurred. Sepsis, acute renal injury, urinary tract infection, abdominal discomfort, and pyrexia were among the serious adverse responses experienced by more than 2% of patients. Fatigue/asthenia, nausea, diarrhoea, anaemia, and constipation were the most prevalent side effects (20%). Anemia and elevated transaminases were the most common grade 3 or 4 adverse events (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis are all immune-mediated adverse responses that might occur.

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Dostarlimab-gxly 500 mg every 3 weeks is the recommended dose and schedule (doses 1 through 4). Starting three weeks following dosage 4, dosing is increased to 1,000 mg every six weeks until illness progression or intolerable toxicity. Dostarlimab-gxly should be delivered as a 30-minute intravenous infusion.

Reference : https://www.fda.gov/

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