The U.S. FDA has approved GSK's Jemperli plus chemotherapy as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer.
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, was first approved in 2021as monotherapy in adult patients with deficient DNA mismatch repair (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Microsatellite instability-high (MSI-H) and dMMR status are actionable biomarkers for advanced endometrial cancer.
Now, the FDA has greenlighted GSK's supplemental BLA supporting the new indication, allowing Jemperli to be used earlier in treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.
The expanded approval was supported by interim results from part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial. The trial met the primary endpoint of investigator-assessed progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit in patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population
“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," said Hesham Abdullah, senior VP and global head of Oncology Development at GSK.
