The sBLA submission is supported by data from Part 1 of RUBY Phase 3 trial which successfully met its primary endpoints of progression-free survival and overall survival
FDA grants priority review to Jemperli for all adult patients with primary advanced or recurrent endometrial cancer. (Credit: GSK plc)
The US Food and Drug Administration (FDA) has granted priority review to GSK’s supplemental biologics license application (sBLA) to expand the indication of Jemperli (dostarlimab) with standard-of-care chemotherapy for all adult patients with endometrial cancer.
GSK seeks approval for Jemperli in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial cancer patients, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.
Presently, the programmed death receptor-1 (PD-1)-blocking antibody is approved by the FDA in combination with chemotherapy, followed by Jemperli alone.
It is indicated to treat adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or microsatellite instability-high (MSI-H).
Jemperli was also approved in the European Union for the same indication in December last year.
For the expanded indication, the FDA has set an action date under the Prescription Drug User Fee Act for 23 August 2024.
The sBLA submission is supported by data from Part 1 of the two-part global, randomised, double-blind, multicentre RUBY Phase 3 trial.
RUBY’s Part 1 met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS).
The results showed a statistically significant and clinically relevant improvement in the overall patient group treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone.
RUBY’s Part 1 is the only clinical trial to show a statistically significant survival advantage in the overall patient population.
The safety analysis from RUBY indicates a safety profile for dostarlimab and carboplatin-paclitaxel consistent with the known safety profiles of the individual agents.
AnaptysBio discovered Jemperli and licensed it to TESARO in March 2014. TESARO is now a part of the GSK, which is in charge of researching, developing, selling, and manufacturing of dostarlimab as well as an TIM-3 antagonist called cobolimab.
In December last year, the British drug maker said that Jemperli with Zejula (niraparib) improved PFS in adult patients with primary advanced or recurrent endometrial cancer in the RUBY Part 2 Phase 3 trial.