Phase III RUBY Clinical Trial Shows Jemperli Could Redefine Cancer Treatment

GSK today announced interim results from Part 1 of the RUBY/ENGOT-EN-6-NSGO/GOG3031 phase III trial investigating Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “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-gxly, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy.”

A statistically significant and clinically meaningful improvement in progression free survival (PFS) was observed for dostarlimab-gxly plus carboplatin/paclitaxel in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population (n=118) and in the overall population (n=494) versus placebo plus chemotherapy. The separation of the lines in the Kaplan-Meier curve below illustrates the significant reduction in risk of disease progression or death in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in the dostarlimab-gxly plus chemotherapy treatment arm compared to the placebo plus chemotherapy treatment arm.

Dr. Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark and RUBY principal investigator, said: “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-gxly to current standard-of-care chemotherapy.”