FDA Approves Dostarlimab-gxly for Adults With dMMR Endometrial Cancer
On April 22, 2021, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline) for the treatment of adults with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer that progressed during or after therapy with a platinum-containing regimen.
This application for this drug was given priority review and breakthrough therapy designation by the FDA.
The efficacy of dostarlimab-gxly was assessed in a patient cohort (A1) from the multi-center, open-label GARNET Trial of patients with advanced solid tumors. A total of 71 patients in the A1 cohort had dMMR recurrent or advanced endometrial cancer that progressed during or after treatment with a platinum-containing regimen.
Patients in the study were given dostarlimab-gxly 500 mg every 3 weeks for 4 doses followed by 1000 mg every 6 weeks.
The overall response rate (ORR) and duration of response (DOR), assessed by blinded independent central review and in accordance with RECIST 1.1 were the main efficacy end points.
The confirmed ORR was 42.3% (95% CI, 30.6%-54.6%), and the complete and partial response rates were 12.7% and 29.6%. The median DOR was not reached, with approximately 90% of patients having durations ≥6 months.
The most common (≥20%) adverse events were fatigue/asthenia, nausea, diarrhea, anemia, and constipation, and the most common (≥2%) grade 3 or 4 adverse reactions were anemia and transaminases increased.
Serious adverse events were reported in 34% of patients receiving dostarlimab-gxly, with >2% having reactions that included sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.
Source: US Food and Drug Administration. FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer. www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-endometrial-cancer. Accessed April 22, 2021.
