The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel) for the first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. The EMA is anticipated to make its approval decision in the first quarter of 2025.
RUBY Phase III Trial Results Support Label Extension
The label extension bid is supported by the results from Part 1 of the RUBY Phase III trial, which successfully met its dual primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS). The data demonstrated that the combination of dostarlimab with carboplatin-paclitaxel provided a statistically significant and clinically meaningful benefit across the full population of patients compared to chemotherapy alone. Notably, dostarlimab plus chemotherapy is the only immuno-oncology-based regimen to exhibit a statistically significant OS benefit in this patient population.-Fineline Info & Tech
