GSK’s Jemperli (dostarlimab) has been approved by the European Commission (EC) in combination with carboplatin-paclitaxel (chemotherapy) to treat a subset of patients with primary advanced or recurrent endometrial cancer.
The EC’s decision, which specifically applies to adults whose tumours have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) deficiency mutations and who are candidates for systemic therapy, makes Jemperli the only frontline immuno-oncology treatment approved in the EU for this patient population.
The regulator has also converted its previous conditional marketing authorisation for Jemperli as a monotherapy for certain adults with pre-treated dMMR/MSI-H recurrent or advanced endometrial cancer to full approval.
GSK’s application supporting the anti-PD-1 therapy’s latest indication is based on positive results from the late-stage RUBY trial, which demonstrated a 72% reduction in the risk of disease progression or death in dMMR/MSI-H patients receiving Jemperli plus carboplatin and paclitaxel compared to chemotherapy alone.
The study also met its second primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit with the Jemperli-based combination in the trial’s overall patient population.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with about 417,000 new cases reported globally every year.
Up to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis, at which point treatment options are limited and the prognosis is poor.
“People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with current standard of care,” explained Hesham Abdullah, senior vice president, global head oncology, research and development, GSK.
He continued: “With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey.”
The EC’s decision comes just a few months after the US Food and Drug Administration approved the Jemperli/chemotherapy combination, also to treat adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer.
The company announced earlier this year that the same patient population in the UK would be granted early access to the Jemperli combination via the Early Access to Medicines Scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation.