GSK has announced promising late-stage results for its Jemperli (dostarlimab) combination treatments in adult patients with primary advanced or recurrent endometrial cancer.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with about 417,000 new cases reported globally every year.
Part one of the phase 3 RUBY trial has been comparing Jemperli plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by Jemperli against chemotherapy plus placebo followed by placebo.
According to the results presented at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancer, there was a 31% reduction in risk of death and a 16.4-month improvement in median overall survival observed in the Jemperli cohort versus chemotherapy alone.
Positive data was also presented from the second part of the study, which has been evaluating Jemperli plus chemotherapy followed by Jemperli plus GSK’s PARP inhibitor Zejula (niraparib) compared to the chemotherapy/placebo combination.
Results demonstrated a 37% reduction in risk of disease progression or death and a six-month improvement in median progression-free survival observed with the addition of Zejula (niraparib) to Jemperli maintenance versus chemotherapy in patients with mismatch repair proficient or microsatellite stable tumours, for whom there are currently no approved immunotherapy-based regimens.
Hesham Abdullah, senior vice president, global head oncology, research and development at GSK said: “The positive data presented… further shows how [Jemperli]-based regimens could benefit a broader set of patients with endometrial cancer.
“The results we’ve seen to date comprise the growing body of evidence supporting the role of [Jemperli] as the backbone of our immuno-oncology development programme.”
The readout comes less than two weeks after Jemperli was recommended by the National Institute for Health and Care Excellence in combination with platinum-containing chemotherapy as a first-line treatment for adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high deficiency (MSI-H) primary advanced or recurrent endometrial cancer.
The agency’s decision was supported by results from RUBY, which demonstrated a more than 70% reduction in the risk of disease progression or death in dMMR and MSI-H patients receiving Jemperli plus carboplatin and paclitaxel relative to chemotherapy alone, as well as benefits in overall survival.