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2023-08-06| Trials & Approvals

FDA Approves GSK’s PD-1 Medicine for Early-Detected Endometrial Cancer

by GeneOnline
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GSK announced that the U.S. Food and Drug Administration (FDA) has approved Jemperli in combination with chemotherapy for the treatment of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. The approval emphasizes the potential of Jemperli as an immuno-oncology treatment, providing hope and new treatment options. 

Related Article: Merck, Eisai’s Keytruda-Lenvima Combo Fails in Melanoma and Colorectal Cancer Trials

Jemperil’s Breakthrough 

Endometrial cancer is a type of cancer that begins in the uterus, more specifically in the cells in the endometrium. It is one of the most common types of gynecologic cancer, with about 60,000 new cases in the U.S. Of these, approximately 13,000 women are projected to succumb to the disease. DMMR endometrial cancer is a subtype of cancer that is characterized by an inability to correct DNA errors during replication. According to GSK, about 20-29% of all endometrial cancers are dMMR/MSI-H. 

Jemperli is the first new frontline treatment approved in decades for endometrial cancer. The FDA has approved its use in combination with carboplatin and paclitaxel in adults. This means that Jemperli can now be indicated earlier in treatment for endometrial cancer. The FDA’s approval is supported by the results from their phase III trial, RUBY. During which Jemperli met its primary endpoints and showed statistical significance. Patients who were treated with a combination of Jemperli and chemotherapy, as opposed to only chemotherapy, showed a 71% reduction in the risk of disease progression. 

Patients with this type of cancer usually have poor long-term outcomes and limited treatment options. The approval of Jemperli is an improvement to the standard of care, and offers hope to patients suffering from this disease. The Global Head of Oncology Development at GSK, Hesham Abdullah, said, “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. In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit. These results and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

GSK’s PD-1 Medicine 

Jemperli is a programmed death receptor-1 (PD-1) blocking antibody. It works by blocking the interaction between the PD-1 ligands with PD-L1 and PD-L2 by binding to the PD-1 receptor. It already has approval in the U.S. as a monotherapy for adults with advanced endometrial cancer or recurrent dMMR. The approval is specifically for its use in patients whose cancer has progressed to a point where they aren’t eligible for surgery or radiation after a previous treatment with a platinum-coating regimen. 

The application for this new indication is also under review in Canada, Australia, Singapore, Switzerland, and the UK. As well as the marketing authorization application by the European Medicines Agency. Jemperil’s use in combination with chemotherapy showed positive results as the risk of progression and death percentage of patients was greatly reduced in the Phase III trial. Ultimately, GSK’s Jemperli approval represents a remarkable milestone in the way dMMR/MSI-H endometrial cancer is treated. This new treatment has the potential of improving the outcomes of patients with endometrial cancer.

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