The authorisation of the indication also converts previous conditional approval for Jemperli to full approval as a monotherapy for second-line dMMR/MSI-H recurrent or advanced endometrial cancer
GSK’s head office in London, UK. (Credit: Ian Wilson from Wikimedia Commons)
GSK said that the European Commission (EC) has granted the marketing authorisation for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy) to treat a certain type of endometrial cancer in the European Union.
Jemperli is an antibody that blocks programmed death receptor-1 (PD-1). It is designed to bind to the PD-1 receptor and block its interaction with the PD-1 ligands PD-L1 and PD-L2.
The commission has approved the Jemperli combination to treat adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are eligible for systemic therapy.
The authorisation of this indication also converts previous conditional approval for Jemperli to full approval as a monotherapy for second-line dMMR/MSI-H recurrent or advanced endometrial cancer.
GSK R&D oncology global head, senior vice president Hesham Abdullah said: “People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with the current standard of care.
“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.
“We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy.”
The approval was based on interim analysis findings from the dMMR/MSI-H population of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial.
The study achieved its primary endpoint of investigator-assessed progression-free survival (PFS).
It also showed a clinically meaningful and statistically significant benefit in patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H group.
The same population observed a 72% reduction in disease progression or death risk in comparison to chemotherapy alone.
In addition, the late-stage trial revealed a robust median duration of follow-up of ≥ 25 months.
Furthermore, an exploratory analysis of overall survival in this population revealed that the addition of Jemperli to chemotherapy caused a 70% reduction in the risk of death relative to chemotherapy alone.