FDA grants regular approval to Jemperli for advanced endometrial cancer
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The FDA granted regular 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 in any setting who are not candidates for curative surgery or radiation.
The FDA previously granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline) — a PD-1 antagonist — for mismatch repair-deficient recurrent or advanced endometrial cancer that progressed on or after a platinum-containing regimen.
The agency based regular approval on results of the multicenter, open-label GARNET trial, which included patients with advanced solid tumors.
The efficacy population included 141 patients with mismatch repair-deficient recurrent or advanced endometrial cancer whose disease progressed on or after a platinum-containing regimen. Study protocol excluded patients treated with prior PD-1/PD-LI-blocking antibodies or other immune checkpoint inhibitors, as well as those who had autoimmune diseases that required systemic immunosuppressant agents within 2 years.
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 major efficacy outcomes.
Researchers reported a confirmed ORR of 45.4% (95% CI, 37-54), with a 15.6% complete response rate and a 29.8% partial response rate.
Median duration of response had not been reached; however, 85.9% of patients had responses that lasted at least 12 months, and 54.7% had responses that lasted at least 24 months.
The most common adverse events included fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation and vomiting.
The FDA announced the regular approval as its Oncologic Drugs Advisory Committee considered whether proposed single-arm trials would be sufficient to gauge the risks and benefits of dostarlimab-gxly in the curative-intent setting for patients with mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer.
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