FDA approves Jemperli for endometrial cancer subset
The FDA granted accelerated approval to dostarlimab-gxly for treatment of certain women with endometrial cancer.
The approval applies to use of the agent by women with mismatch repair-deficient recurrent or advanced disease that progressed on or after a platinum-containing regimen.
Dostarlimab-gxly (Jemperli, GlaxoSmithKline) is a PD-1 antagonist.
The FDA — which had granted priority review and breakthrough therapy designations to dostarlimab-gxly for this indication — based the approval on results of a cohort in the multicenter, open-label GARNET trial.
The efficacy population included 71 women with mismatch repair-deficient recurrent or advanced endometrial cancer who progressed on or after a platinum-containing regimen.
Women received 500 mg dostarlimab-gxly via IV every 3 weeks for four doses, followed by 1,000 mg via IV every 6 weeks. Overall response rate and duration of response as assessed by blinded independent central review served as the main efficacy endpoints.
Researchers reported a confirmed ORR of 42.3% (95% CI, 30.6-54.6), with a 12.7% complete response rate and 29.6% partial response rate. Median duration of response had not been reached. However, the majority of responses (93.3%) lasted at least 6 months, with ongoing responses at the time of last assessment ranging from 2.6 months to 22.4 months.
About one-third (34%) of women experienced adverse events, the most common of which were fatigue/asthenia, nausea, diarrhea, anemia and constipation.
The most common grade 3 or grade 4 adverse events were anemia and elevated transaminase.
Serious adverse events included sepsis, acute kidney injury, urinary tract infection, abdominal pain and pyrexia.
The FDA also approved the Ventana MMR RxDx Panel (Roche) as a companion diagnostic device to select women with endometrial cancer for treatment with dostarlimab-gxly.