GSK has secured approval for Jemperli (dostarlimab) plus chemotherapy from the US Food and Drug Administration (FDA) for the treatment of a type of endometrial cancer in adult patients.
The approval is for Jemperli in combination with chemotherapy consisting of carboplatin and paclitaxel. This should be followed by Jemperli as a single agent.
According to GSK, the combination has been indicated for patients having primary advanced or recurrent endometrial cancer that exhibits mismatch repair deficient (dMMR), as established by an FDA-approved test, or microsatellite instability-high (MSI-H).
The supplemental biologics license application (sBLA) that supports the new indication received priority review and obtained approval before the Prescription Drug User Fee Act action date.
Following the approval, Jemperli is now indicated at an earlier stage of treatment, in combination with chemotherapy, for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.
Jemperli is already approved in the US as a monotherapy for adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or after a previous platinum-containing regimen in any setting and who are not eligible for curative surgery or radiation.
The FDA approval is based on interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial, which show a median duration of follow-up of ≥ 25 months.
The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), revealing a statistically significant and clinically meaningful benefit for patients treated with Jemperli in combination with chemotherapy in the dMMR/MSI-H population.
There was a 71% reduction in the risk of disease progression or death observed within the patient population.
GSK senior vice president and oncology development global head Hesham Abdullah said: “Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression.
“In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit.
“These results and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”
