FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancer
Regulatory approval: On Feb 9, 2023, the FDA approved dostarlimab-gxly (Jemperli) for adults with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, determined by an FDA-approved test, that progressed on/after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation. Efficacy was evaluated in the GARNET trial; confirmed ORR was 45.4% with median duration of response not reached.
FDA D.I.S.C.O. Burst Edition: Jemperli approval in dMMR endometrial cancer (Feb 9, 2023)
Type: Regulatory approval (FDA)
On February 9, 2023, the FDA approved dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
The FDA noted that dostarlimab-gxly previously received accelerated approval (April 2021) for adults with dMMR recurrent or advanced endometrial cancer that progressed on or following a prior platinum-containing regimen.
Efficacy evidence: The FDA evaluated efficacy for the regular approval in GARNET, a multicenter, multicohort, open-label trial in patients with advanced solid tumors. The endometrial cancer efficacy cohort included 141 patients with dMMR recurrent or advanced endometrial cancer progressed on/after platinum. Key exclusions included prior PD-1/PD-L1–blocking antibodies or other checkpoint inhibitors, and autoimmune disease requiring systemic immunosuppressants within 2 years.
Major endpoints were ORR and DOR (blinded independent central review; RECIST v1.1). Confirmed ORR was 45.4% (CR 15.6%, PR 29.8%). Median DOR was not reached; 85.9% had DOR >12 months and 54.7% had DOR >24 months.
Safety: Common adverse reactions (>20%) included fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting. Immune-mediated adverse reactions can occur (eg, pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, skin reactions).