Dostarlimab-gxly Receives Full FDA Approval in dMMR Endometrial Cancer

The FDA has granted full approval to dostarlimab-gxly (Jemperli) as treatment for patients with mismatch repair deficient (dMMR) recurrent/advanced endometrial cancer, according to a press release from the FDA.¹

The regular approval was based on data from the phase 1 GARNET trial (NCT02715284), which included a total of 141 patients with dMMR recurrent/advanced endometrial cancer who had progressed following a platinum-containing treatment.

Dostarlimab yielded a confirmed overall response rate of 45.4% (95% CI, 37.0%-54.0%) including a 15.6% complete response rate and 29.8% partial response rate. The median duration of response was not reached, and 85.9% and 54.7% of patients had responses lasting 12 months or more and 24 months or more, respectively.

Frequent adverse effects (AEs) included fatigue, anemia, rash, nausea, diarrhea, constipation, and vomiting. Immune-mediated AEs included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.

The FDA granted accelerated approval to dostarlimab for dMMR recurrent or advanced endometrial cancer in April 2021, which was also supported by data from the GARNET trial.²

Reference

1. FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer. News release. FDA. February 9, 2023. Accessed February 9, 2023. http://bit.ly/3xbGuH2
2. FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker. News release. FDA. April 21, 2021. Accessed February 9, 2023. bit.ly/3YARJ7o