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news.GSK has received the US Food and Drug Administration's (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel).
The latest acceptance will allow GSK to potentially expand use of Jemperli for treatment of primary advanced or recurrent endometrial cancer in adult patients. Credit: Elen Sher/Unsplash.
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This acceptance will allow GSK to potentially expand the use of Jemperli for the treatment of primary advanced or recurrent endometrial cancer in all the adult patients, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.
The FDA has now granted ‘Priority Review’ for the sBLA with a Prescription Drug User Fee Act action date set for 23 August 2024.
The application is supported by results from Part 1 of the RUBY Phase III trial.
GSK said that the trial met its primary endpoints of progression-free survival (PFS) as well as overall survival (OS).
It showcased significant benefits in the overall patient population treated with dostarlimab plus carboplatin-paclitaxel compared to those treated using chemotherapy alone.
Notably, the company said that RUBY Part 1 is the only clinical trial to demonstrate a statistically significant survival benefit in the overall population of patient.
RUBY’s safety and tolerability analysis further indicated that the combination of dostarlimab and chemotherapy (carboplatin-paclitaxel) aligns with the known safety profiles of the individual agents.
The OS data from the trial were also presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer on 16 March 2024.
RUBY is a global, double-blind, randomised, multicentre Phase III trial, involving patients with primary advanced or recurrent endometrial cancer. It was conducted in two parts.
Part 1 evaluates dostarlimab plus carboplatin and paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo, which is followed by placebo.
Part 2 is assessing the efficacy of dostarlimab plus carboplatin and paclitaxel followed by dostarlimab in combination with niraparib versus placebo plus carboplatin and paclitaxel that is followed by placebo.
The RUBY trial is part of an international alliance between the European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation.
