FDA expands Jemperli approval for endometrial cancer
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The FDA expanded the approval of dostarlimab-gxly for treatment of endometrial cancer.
Last year, the agency approved dostarlimab-gxly (Jemperli, GSK) plus carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for treatment of women with primary advanced or recurrent endometrial cancer that is mismatch repair-deficient or microsatellite instability-high.
The expanded indication authorizes the same regimen for all women with primary advanced or recurrent endometrial cancer.
Dostarlimab is a PD-1 antagonist.
The FDA based expanded approval on interim results from the randomized phase 3 RUBY trial.
The trial included 494 women with primary advanced stage III/stage IV or first recurrent endometrial cancer.
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.
Investigators stratified by mismatch repair/microsatellite instability status, receipt of external pelvic radiotherapy and disease status (primary stage III, primary stage IV or recurrent disease).
Investigator-assessed PFS in the mismatch repair/microsatellite instability subgroup and overall populations, as well as OS in the entire study population, served as primary endpoints.
In the overall population, results showed significantly longer PFS (median, 11.8 months vs. 7.9 months; HR = 0.64; 95% CI, 0.51-0.8) and OS (median, 44.6 months vs. 28.2 months; HR = 0.69; 95% CI, 0.54-0.89) with dostarlimab-gxly.
Adverse events that occurred among at least 20% of patients treated with dostarlimab-gxly plus carboplatin and paclitaxel included anemia, increased creatinine, decreased white blood cell count, peripheral neuropathy, nausea, fatigue, alopecia, increased glucose, low platelets, lymphopenia, arthralgia, rash, neutropenia, liver function test abnormalities, diarrhea, constipation, abdominal pain, decreased albumin, dyspnea, urinary tract infection, decreased appetite, increased amylase and vomiting.
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