Clinical Trials

GSK shares promising clinical trial results for endometrial cancer therapy

GSK has announced promising results from part 1 of the RUBY/ENGOT-EN6/GOG3031/ NSGO phase 3 trial for Jemperli (dostarlimab) alongside standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab, compared to chemotherapy and a placebo, in adult patients with primary advanced or recurrent endometrial cancer.
Thetrialdemonstratedastatisticallysignificantand clinically meaningful improvement in progressionfree survival (PFS) in the group that received Jemperli plus chemotherapy, compared to those who received a placebo plus chemotherapy. This first interim analysis also shows a clinically meaningful overall survival (OS) trend in patients treated with Jemperli compared to the placebo group. This analysis was done at 33% maturity, and statistical significance was not reached, however OS follow-up continues and further analysis is already planned.
The drug showed a consistent safety and tolerability profile, with the most common adverse events being nausea, alopecia, fatigue and anaemia.
Hesham Abdullah, senior vice president and global head of Oncology Development at GSK, commented: “These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy.”
Dr Mansoor Raza Mirza, chief oncologist at Copenhagen University Hospital, Denmark and RUBY principal investigator, added: “Clinical practice has been waiting decades for a meaningful advancement in the standard of care for primary advanced or recurrent endometrial cancer. The results from the RUBY clinical trial, especially given the difficult-to-treat histologies included in the trial, demonstrate support for a new treatment standard with the addition of dostarlimab to current standard-of-care chemotherapy.”