FDA expands Jemperli approval for endometrial cancer
Click Here to Manage Email Alerts
The FDA approved dostarlimab in combination with chemotherapy for certain women with endometrial cancer.
The designation applies to use of dostarlimab (Jemperli, GSK) with carboplatin and paclitaxel, followed by dostarlimab as a single agent, for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
Dostarlimab is a PD-1 antagonist. The FDA previously approved the agent for treatment of mismatch repair-deficient recurrent or advanced endometrial cancer that progressed on or after a platinum-containing regimen.
The new indication is based on interim results from part 1 of the randomized phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial.
The trial included 494 women with primary advanced stage III/stage IV or first recurrent endometrial cancer. A prespecified subgroup of 118 women had dMMR/MSI-H tumors.
Researchers randomly assigned women 1:1 to dostarlimab dosed at 500 mg or placebo plus carboplatin and paclitaxel every 3 weeks for six cycles, followed by 1,000 mg dostarlimab or placebo every 6 weeks for up to 3 years.
Investigator-assessed PFS, OS and safety served as primary endpoints.
The study met is primary endpoint.
As Healio previously reported, results presented at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancer showed 2-year PFS rates of 36.1% with the dostarlimab regimen and 18.1% with placebo (HR = 0.64; 95% CI, 0.51-0.8).
In the dMMR/MSI-H subgroup, researchers observed significantly longer median PFS with dostarlimab (30.3 months vs. 7.7 months; HR = 0.29; 95% CI, 0.17-0.5).
The trial is continuing so researchers can assess OS in the intent-to-treat population.
Treatment-emergent adverse events that occurred among at least 20% of patients treated with dostarlimab plus chemotherapy included rash, diarrhea, hypothyroidism and hypertension.
Read more about
Click Here to Manage Email Alerts