GSK has announced positive results from a late-stage trial of its PD-1 inhibitor Jemperli (dostarlimab) plus chemotherapy in adults with primary advanced or recurrent endometrial cancer.
The phase 3 RUBY trial has been evaluating Jemperli plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by Jemperli as a single agent, compared to placebo plus chemotherapy.
Results from a planned analysis showed that the trial met its primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population.
A clinically meaningful overall survival benefit was observed in both pre-specified subpopulations in the trial, GSK said, including mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroups.
The company previously reported that the study met its other primary endpoint of progression-free survival and demonstrated a 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively.
Hesham Abdullah, senior vice president, global head oncology, research and development, GSK, said: “With [the] headline results from part one of the phase 3 RUBY trial, Jemperli plus chemotherapy has become the only immuno-therapy combination to show a survival benefit in this broader patient population in this treatment setting.
“We look forward to sharing detailed results of this analysis with regulatory authorities and the larger scientific community.”
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecologic cancer in developed countries, with about 417,000 new cases reported globally every year.
Approximately 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.
Jemperli currently has regulatory approvals to treat specific subtypes of advanced or recurrent endometrial cancer.
In July, it was approved by the US Food and Drug Administration (FDA) for use alongside carboplatin and paclitaxel in adults with primary advanced or recurrent endometrial cancer that is dMMR or MSI-H.
Jemperli was also approved in the UK in October in combination with platinum-containing chemotherapy to treat adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.