Dostarlimab regimen extends survival for women with advanced endometrial cancer
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A regimen containing dostarlimab plus standard-of-care chemotherapy significantly improved OS compared with chemotherapy alone in women with primary advanced or recurrent endometrial cancer, according to the agent’s manufacturer.
Planned interim analyses from part 1 of the phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial showed statistically significant OS and PFS benefit associated with use of dostarlimab (Jemperli, GSK) — a PD-1 inhibitor — in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors.
The FDA previously approved the regimen — comprising dostarlimab plus carboplatin and paclitaxel, followed by dostarlimab as a single agent — for women with primary advanced or recurrent dMMR/MSI-H endometrial cancer.
“With [these] results from part 1 of the phase 3 RUBY trial, dostarlimab plus chemotherapy has become the only immunotherapy combination to show a survival benefit in this broader patient population in this treatment setting,” Hesham Abdullah, MD, MSc, senior vice president, global head of oncology R&D at GSK, said in a company-issued press release. “We look forward to sharing detailed results of this analysis with regulatory authorities and the larger scientific community.”
The double-blind RUBY trial examined the safety and efficacy of dostarlimab plus standard-of-care carboplatin and paclitaxel vs. carboplatin and paclitaxel alone among 494 women with primary advanced or recurrent endometrial cancer.
OS and PFS served as dual primary endpoints for the trial.
A previous analysis showed a 72% reduction in the risk for disease progression or death among the dMMR/MSI-H population (HR = 0.28; 95% CI, 0.16-0.5), with a similar 36% decrease in the overall patient population (HR = 0.64; 95% CI, 0.51–0.8), according to the manufacturer.
Topline data from the trial suggests an acceptable safety profile that is consistent with known toxicities associated with dostarlimab plus carboplatin and paclitaxel. The most common treatment-related toxicities occurring in more than 25% of patients included nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea and myalgia.
The manufacturer said it plans to submit full results from the analysis to a major medical journal and for presentation at an upcoming major scientific meeting.
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