NEW YORK – The US Food and Drug Administration has approved for marketing GlaxoSmithKline's Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
The approval comes less than two months after the FDA accepted the firm's supplemental biologics license application seeking approval for the PD-1-targeted monoclonal antibody and granting the application a priority review.
With the new approval, Jemperli is now indicated earlier in treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. GSK said that it is the first new frontline option in decades for treating dMMR/MSI-H endometrial cancer patients.
As part of its sBLA application, GSK submitted an interim analysis from the first part of the Phase III RUBY trial, in which investigators found that Jemperli-chemo provided a statistically significant and clinically meaningful improvement in progression-free survival at two years among patients with dMMR/MSI-H endometrial cancer and in the overall treatment population compared to chemotherapy alone. The RUBY investigators published the study results in March in the New England Journal of Medicine.
The trial met the primary endpoint of progression-free survival, demonstrating a statistically significant and clinically meaningful benefit in patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population. According to an FDA statement, patients who received the Jemperli-chemo combo had a median PFS of 30.3 months versus 7.7 months for patients who received the placebo-containing regimen.
An estimated 20 percent to 29 percent of endometrial cancers are dMMR/MSI-H.
Hesham Abdullah, senior VP and global head of oncology development at GSK, said the approval "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."
The FDA conducted the review under its Project Orbis initiative, which provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, it collaborated with the Australian Therapeutic Goods Administration, Health Canada, Switzerland’s Swissmedic, and the UK's Medicines and Healthcare products Regulatory Agency.
GSK noted that a marketing authorization application is also under review by the European Medicines Agency.