EMA to review GSK's Jemperli for expanded use in all advanced/recurrent endometrial cancer patients.
GSK plc (LSE/NYSE: GSK) has announced that
the European Medicines Agency (EMA) has accepted its application to extend the
use of Jemperli (dostarlimab) in combination with standard chemotherapy
(carboplatin and paclitaxel) to all adult patients with primary advanced or
recurrent endometrial cancer. The EMA's Committee for Medicinal Products for
Human Use will now begin the formal review process to recommend approval to the
European Commission, with a decision anticipated in the first half of 2025.
At present, in the EU, Jemperli combined
with carboplatin and paclitaxel is approved for adult patients who qualify for
systemic therapy for primary advanced or recurrent endometrial cancer that is
mismatch repair deficient (dMMR) or has high microsatellite instability
(MSI-H). If this new application is approved, dostarlimab's use would be
expanded to all patients with primary advanced or recurrent endometrial cancer,
irrespective of their biomarker status, including those with mismatch repair
proficient (MMRp) or microsatellite stable (MSS) tumors, for which there are
currently no approved frontline immunotherapy treatments in the EU.
This application is based on findings from
Part 1 of the RUBY phase III trial. The trial achieved its primary goals of
investigator-assessed progression-free survival (PFS) and overall survival
(OS), showing a statistically significant and clinically meaningful benefit for
patients treated with dostarlimab plus carboplatin-paclitaxel compared to those
receiving chemotherapy alone. RUBY Part 1 is the only clinical trial to
demonstrate a statistically significant overall survival benefit in this
patient group. Safety and tolerability analyses from RUBY indicated that the
safety profile of dostarlimab combined with carboplatin-paclitaxel was
generally consistent with the known safety profiles of the individual drugs.