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Dostarlimab With Carboplatin–Paclitaxel Prolonged Progression-Free Survival Among Patients With Primary Advanced or Recurrent Endometrial Cancer
Study results from a phase 3 trial found dostarlimab plus carboplatin–paclitaxel significantly increased progression-free survival (PFS) among patients with primary advanced or recurrent endometrial cancer.
This double-blind, randomized, placebo-controlled trial enrolled 494 patients with primary advanced stage III/ IV or first recurrent endometrial cancer, 118 of which had mismatch repair–deficient (dMMR), microsatellite instability–high (MSI-H) tumors. Patients were randomly assigned on a 1-to-1 basis to receive either 500 mg dostarlimab or placebo, plus carboplatin and paclitaxel every 3 weeks, followed by 1000 mg dostarlimab or placebo every 6 weeks for up to 3 years. The primary outcomes were PFS and overall survival (OS).
In the dMMR–MSI-H population, the estimated PFS at 24 months was 61.4% in the dostarlimab group and 15.7% in the placebo group (hazard ratio [HR] for progression or death, 0.28; 95% confidence interval [CI], 0.16 to0.50; P < .001). In the overall population, PFS at 24 months was 36.1% in the dostarlimab group and 18.1% in the placebo group (HR, 0.64; 95% CI, 0.51 to0.80; P < .001). Overall survival at 24 months was 71.3% with dostarlimab and 56% with placebo (HR for death, 0.64; 95% CI, 0.46 to 0.87).
The most notable adverse events that either occurred or worsened during treatment were nausea, alopecia, and fatigue. Severe and serious adverse events were more frequent in the dostarlimab group than in the placebo group.
The study authors concluded, “Dostarlimab plus carboplatin–paclitaxel significantly increased progression-free survival among patients with primary advanced or recurrent endometrial cancer, with a substantial benefit in the dMMR–MSI-H population.”
Source:
Mirza M, M.D., Chase D, et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med. 2023; 388:2145-2158. doi:10.1056/NEJMoa2216334
