The US health regulator granted priority review for GSK’s sBLA and assigned a Prescription Drug User Fee Act action date of 23 September 2023
GSK secures FDA priority review for Jemperli, chemo combination for endometrial cancer. (Credit: GSK plc.)
GSK announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of endometrial cancer in certain adult patients.
In the sBLA, the combination is intended to treat patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
In February this year, the FDA approved Jemperli to treat a form of endometrial cancer in adults who are not eligible for curative surgery or radiation. The approval is for dMMR recurrent or advanced endometrial cancer that has advanced after a prior platinum-containing regimen.
The US health regulator granted priority review for GSK’s sBLA and assigned a Prescription Drug User Fee Act action date of 23 September 2023.
The application is currently being reviewed under the FDA Project Orbis framework, which facilitates concurrent reviews among the US, Canadian, Australian, Singapore, Switzerland, and UK health authorities.
GSK SVP and oncology development global head Hesham Abdullah said: “We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase III RUBY trial.
“Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, and there is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy.”
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody. It targets the PD-1 receptor and prevents it from interacting with the PD-1 ligands PD-L1 and PD-L2.
The sBLA is based on the prespecified interim analysis findings from the first part of the RUBY Phase 3 trial.
In the study, the combination met its primary endpoint of investigator-assessed progression-free survival (PFS).
The results showed a statistically significant and clinically meaningful benefit in individuals subjected to Jemperli plus carboplatin-paclitaxel in the dMMR/MSI-H population and in the overall population.
GSK said that the data demonstrated a median duration of follow-up of ≥24.8 months.
Additionally, the safety and tolerability analysis from the RUBY trial for Jemperli and carboplatin-paclitaxel was found consistent with the known safety profiles of the individual agents.
RUBY is a two-part global, randomised, double-blind, multicentre trial. Part 1 is evaluating Jemperli plus carboplatin-paclitaxel followed by Jemperli versus carboplatin-paclitaxel plus placebo followed by placebo.
The dual-primary endpoints in Part 1 are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and overall survival (OS).
Recently, dostarlimab received the breakthrough therapy designation from the FDA for this prospective new indication.