GSK's Jemperli approved in US for new endometrial cancer frontline treatment

GSK plc announced on July 31, 2023, that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent. This approval is for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

This represents the first new frontline treatment option in decades for patients with this specific type of endometrial cancer, who historically face significant unmet needs and often experience poor long-term outcomes with current standard care. "Today's expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer," said Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK. He noted that the RUBY trial showed Jemperli plus chemotherapy reduced the risk of disease progression or death by 71% compared to chemotherapy alone in this population.

The FDA approval is supported by interim analysis results from Part 1 of the Phase III RUBY trial. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit for patients with dMMR/MSI-H treated with Jemperli plus chemotherapy. Overall survival (OS) is being further assessed.

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 following a prior platinum-containing regimen and who are not candidates for curative surgery or radiation.