Dostarlimab-gxly regimen extends PFS in primary advanced or recurrent endometrial cancer
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A combination of dostarlimab-gxly and standard-of-care chemotherapy significantly extended PFS compared with placebo and chemotherapy among women with primary advanced or recurrent endometrial cancer, topline data showed.
Researchers observed a statistically significant and clinically meaningful PFS benefit with the dostarlimab-gxly (Jemperli, GSK) regimen in a prespecified subgroup of women with mismatch repair-deficient/microsatellite instability-high disease, as well as among the overall population in part 1 of the randomized, phase 3 RUBY trial, according to a press release from the manufacturer. A subgroup of women with mismatch repair-proficient/microsatellite instability-high disease demonstrated a clinically relevant PFS benefit, the press release stated.
The interim analysis also revealed a favorable OS trend in the overall population and both subgroups, although these data remained immature.
Dostarlimab-gxly, a PD-1-blocking antibody, had a safety and tolerability profile consistent with that of similar regimens in clinical trials, according to the manufacturer. Common treatment-emergent adverse events among women who received dostarlimab-gxly plus chemotherapy included nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation and diarrhea.
“Patients with primary advanced or recurrent endometrial cancer have limited treatment options,” Hesham Abdullah, senior vice president and global head of oncology development for GSK, said in the press release. “Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy. Based on these positive headline results from the RUBY phase 3 trial, GSK intends to seek regulatory approvals for a potential new indication for dostarlimab-gxly in the treatment of primary advanced or recurrent endometrial cancer.”
Part 1 of the global, double-blind, multicenter trial is investigating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly vs. carboplatin-paclitaxel plus placebo followed by placebo. Investigator-assessed PFS according to RECIST version 1.1 and OS serve as the primary endpoints.
Part 2 of the trial is analyzing dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly plus the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula, GSK) vs. placebo plus carboplatin-paclitaxel followed by placebo. Investigator-assessed PFS serves as the primary endpoint.
The manufacturer expects regulatory submissions based on RUBY results to occur in the first half of next year. Complete results will be published in a medical journal and presented at a future medical meeting.
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