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FDA Approves Dostarlimab-Gxly for Patients With dMMR Recurrent or Advanced Endometrial Cancer
On February 9, 2023, the US Food and Drug Administration (FDA) granted approval to dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer where the disease has progressed while on or following a previous platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
The FDA approval is based on results from the multicenter, multicohort, open-label GARNET trial, which enrolled 141 patients with advanced solid tumors. All patients included in the study had dMMR recurrent or advanced endometrial cancer that had progressed on or after a platinum-containing regimen. If patients had been treated previously with programmed death receptor-1/programmed death-ligand 1 (PD-1/PD-L1)-blocking antibodies, other immune checkpoint inhibitors, or had autoimmune diseases requiring systemic immunosuppressant agents within 2 years, they were excluded from the study.
The main outcome measures of the trial were overall response rate (ORR) and duration of response (DOR), which were assessed by blinded independent central review per RECIST 1.1 guidelines.
Key results from the trials include:
- The confirmed ORR was 45.4% (95% confidence interval [CI]: 37.0, 54.0), with a 15.6% complete response rate and a 29.8% partial response rate.
- The median DOR was not reached, with 85.9% of patients having a duration of 12 months or longer and 54.7% of patients having a duration of 24 months or longer (range: 1.2+, 52.8+).
The most common adverse reactions, occurring in ≥20% of patients, were fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting. The study also found that immune-mediated adverse reactions can occur, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.
The recommended dosage of dostarlimab-gxly is 4 doses of 500 mg every 3 weeks and it should be administered as an intravenous infusion over 30 minutes. Beginning 3 weeks after dose 4, patients should receive 1,000 mg every 6 weeks until disease progression or unacceptable toxicity occurs.
Reference
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer. United States Food and Drug Administration. February 9, 2023. Accessed March 23, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-dostarlimab-gxly-dmmr-endometrial-cancer
