The European Commission (EC) has granted marketing authorisation for GSK’s Jemperli (dostarlimab) plus chemotherapy regimen to treat adults with primary advanced or recurrent endometrial cancer.
Jemperli is indicated for usage along with chemotherapy comprising carboplatin plus paclitaxel in mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) advanced or recurrent endometrial cancer patients who are candidates for systemic treatment.
The EC also granted full approval for the usage of Jemperli as a single agent in adults with dMMR/MSI-H recurrent or advanced endometrial cancer.
These patients should have advanced on or after previous therapy with a platinum-containing treatment to be eligible to receive Jemperli.
Jemperli monotherapy was previously indicated to treat these patients under conditional approval from the EC.
The latest authorisation is based on interim analysis data from the dMMR/MSI-H population in the Part 1 portion of the Phase III RUBY clinical trial of Jemperli plus chemotherapy.
The Jemperli regimen offered progression-free survival in patients, meeting the primary endpoint.
The treatment also cut down the risk of disease progression or mortality by 72% versus chemotherapy alone.
A programmed death receptor-1 (PD-1)-inhibiting antibody, Jemperli attaches to the PD-1 receptor and hinders its interaction with the PD-1 ligands.
GSK research and development, oncology global head and senior vice-president Hesham Abdullah stated: “People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with 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.”
Last month, Health Canada approved Jemperli plus carboplatin and paclitaxel to treat endometrial cancer in adults.
