FDA Approves GSK’s Jemperli Combo for Expanded Endometrial Cancer Use

The US Food and Drug Administration (FDA) has granted approval for GSK’s Jemperli (dostarlimab-gxly) to be used as part of a combination treatment for a wider spectrum of endometrial cancer patients. This approval allows Jemperli to be administered alongside carboplatin and paclitaxel chemotherapy and subsequently as a standalone treatment for all adults suffering from primary advanced or recurrent endometrial cancer.

Previously, Jemperli’s approved indication, in combination with chemotherapy, was limited to patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors, who make up a significant 75% of those diagnosed with this cancer type. Endometrial cancer originates in the inner lining of the uterus and is noted as the most prevalent gynecological cancer in developed nations, with around 417,000 new cases reported globally each year.

The FDA’s recent approval was substantiated by positive outcomes from the first part of the late-stage RUBY clinical trial. This trial demonstrated a 31% reduction in the risk of death for patients treated with the Jemperli combination in comparison to those who received chemotherapy plus a placebo followed by a placebo. Additionally, there was a 16.4-month improvement in median overall survival for patients treated with Jemperli and chemotherapy versus those who received only chemotherapy.

Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development at GSK, commented on the significance of the results, stating, “Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer, regardless of biomarker status.”

Supporting this sentiment, Matthew Powell, the US Principal Investigator of the RUBY trial from Washington University School of Medicine, noted that the initial approval of Jemperli combined with chemotherapy marked a substantial change in treatment practices for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. He added that the expanded approval would provide even more patients the opportunity for better outcomes.

This latest FDA approval follows a recommendation from the National Institute for Health and Care Excellence from a few months prior. They endorsed Jemperli in combination with platinum-containing chemotherapy as a first-line treatment for adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who qualify for systemic therapy. This recommendation, made in March, was likewise based on results from the RUBY trial, which indicated over a 70% reduction in the risk of disease progression or death for dMMR and MSI-H patients treated with Jemperli plus carboplatin and paclitaxel, as well as improvements in overall survival.

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