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GSK’s Jemperli shows promise in phase 3 endometrial cancer trial

An interim analysis noted the trial met its primary endpoint of progression-free survival


GSK has announced positive results from a planned interim analysis of part one of its phase 3 RUBY trial, investigating Jemperli (dostarlimab) in the treatment of adult patients with primary advanced or recurrent endometrial cancer.

Part one of the trial is evaluating Jemperli plus standard of care chemotherapy (carboplatin-paclitaxel) followed by Jemperli compared to chemotherapy plus placebo followed by placebo.

According to the interim analysis, the trial met its primary endpoint of investigator-assessed progression-free survival (PFS), and showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup and in the overall population.

A clinically relevant benefit in PFS was also observed in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroup.

While the overall survival data was immature at the time of this analysis, the company said it observed a ‘favourable’ trend in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups.

Additionally, the safety and tolerability profile of Jemperli in the trial was consistent with clinical trials of similar regimens.

Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecologic cancer in the US and the second most common gynaecologic cancer globally. Approximately 15% to 20% of women with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.

“Patients with primary advanced or recurrent endometrial cancer have limited treatment options. Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy,” said Hesham Abdullah, senior vice president, global head of oncology development, GSK.

He continued: "Based on these positive headline results from the RUBY phase 3 trial, GSK intends to seek regulatory approvals for a potential new indication for [Jemperli] in the treatment of primary advanced or recurrent endometrial cancer.”

Regulatory submissions are anticipated in the first half of 2023, the company said in a statement, and full results from the trial will be published in a medical journal and presented at an upcoming scientific meeting.

In the US, Jemperli is indicated for adult patients with dMMR recurrent or advanced endometrial cancer that have progressed on or following prior treatment with a platinum-containing regimen, as well as for patients with dMMR recurrent or advanced solid tumours that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Article by
Emily Kimber

2nd December 2022

From: Research



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