FDA Approves Jemperli/Chemo Regimen for Endometrial Cancer Subset

The Food and Drug Administration (FDA) approved Jemperli (dostarlimab) plus carboplatin and paclitaxel followed by Jemperli alone for the treatment of adults with primary advanced or recurrent mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer, as determined by an FDA-approved test, according to a press release from GSK, the drug’s manufacturer.

This is the first frontline immunotherapy-chemotherapy combination approved for this patient population. Of note, in February, the FDA approved single-agent Jemperli for patients with dMMR endometrial cancer.

“As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who have had limited treatment options. Based on the results from the RUBY clinical trial, I look forward to the addition of Jemperli to chemotherapy becoming a new standard of care for patients,” Dr. Matthew Powell, chief of the Division of Gynecologic Oncology at Washington University School of Medicine, and US principal investigator of the RUBY trial, said in the press release.

The approval is based on findings from an interim analysis of part 1 of the phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO clinical trial, which showed a meaningful improvement in progression-free survival (time from treatment until death or disease worsens). In the dMMR/MSI-H group, researchers observed a 71% reduction in the risk of disease progression or death with the regimen.

“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,” Hesham Abdullah, senior vice president and Global Head of Oncology Department at GSK, said in the release.

Researchers are still tracking overall survival (time from treatment until death of any cause) in the trial.

“The endometrial cancer community is thrilled by today’s news, which changes the treatment paradigm for a population with long-term unmet needs,” Wenora Johnson, president of the board of directors of Facing Our Risk of Cancer Empowered (FORCE), said in the release. “FORCE is grateful for the many participants and researchers who contributed to this important study. As an endometrial cancer survivor, I know how much this approval offers hope for patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer.”

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