GSK Wins Expanded Approval in Europe for Jemperli in Rare Endometrial Cancer
August 1, 2023
Rare Daily Staff
The U.S. Food and Drug Administration expanded the approved use of GSK’s immunotherapy Jemperli to include the treatment of adult patients with primary advanced or recurrent endometrial cancer.
The approval is for Jemperli in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for those cases in which the endometrial cancer is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The supplemental Biologics License application supporting the new indication received Priority Review.
With this approval, Jemperli is now indicated earlier in treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Jemperli is already approved in the United States as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
Endometrial cancer is one of the most common gynecologic cancers in developed countries, and there are about 60,000 new cases of endometrial cancer diagnosed every year in the United States. Approximately 15 to 20 percent of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. An estimated 20 to 29 percent of all endometrial cancers are dMMR/MSI-H. Chemotherapy used alone has been the current standard of care for primary advanced or recurrent endometrial cancer, and many patients eventually experience disease progression.
The FDA approval is supported by interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial, which reflect a robust median duration of follow-up of ≥ 25 months. The trial met the primary endpoint of investigator-assessed 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.
In the dMMR/MSI-H population, a 71 percent reduction in the risk of disease progression or death was observed. Part 1 of the RUBY trial continues to assess overall survival in the intent-to-treat population, a dual-primary endpoint alongside investigator-assessed progression-free survival.
The safety and tolerability profile for Jemperli plus carboplatin and paclitaxel was generally consistent with the known safety profiles of the individual agents. The most common treatment-emergent adverse events (≥ 20 percent) in patients receiving Jemperli plus chemotherapy were rash, diarrhea, hypothyroidism and hypertension.
“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 and global head of oncology development for GSK. “Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression.”
Photo: Hesham Abdullah, senior vice president and global head of oncology development for GSK
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