GSK has received approval from the US Food and Drug Administration (FDA) for Jemperli (dostarlimab), in combination with carboplatin and paclitaxel, as a monotherapy to treat adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody which attaches to the PD-1 receptor and prevents its interaction with PD-L1 and PD-L2 ligands.
The new indication’s supplemental biologics licence application received priority review and approval before the Prescription Drug User Fee Act action date.
The approval from the FDA was based on an interim analysis of data from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III study.
A reduction of 71% in the risk of disease progression or death was noted in the dMMR/MSI-H population.
Part 1 of the RUBY trial continues to evaluate overall survival in the intent-to-treat population, a dual-primary endpoint along with investigator-assessed progression-free survival (PFS).
It showed meaningful benefit for patients who received Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population, thereby achieving the primary endpoint of PFS.
GSK Oncology Development global head and senior vice-president Hesham Abdullah stated: “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.”
Jemperli has already secured approval in the US as a monotherapy to treat adult patients with dMMR recurrent or advanced endometrial cancer.
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