FDA Accepts GSK's Application for Expanded Use of Jemperli in Endometrial Cancer Treatment

GSK PLC has revealed that the US Food and Drug Administration (FDA) has accepted their supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in conjunction with standard-of-care chemotherapy (carboplatin and paclitaxel) to broaden treatment options for all adult patients with primary advanced or recurrent endometrial cancer, which includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors. The current FDA approval for Jemperli is in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent, but it's limited to patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. This marks a significant expansion of the drug's indication, potentially offering a new treatment avenue for a broader patient population.

The FDA has granted Priority Review for this application, indicating the agency's recognition of the potential therapeutic benefits and urgency of expanding treatment options for endometrial cancer patients. The Prescription Drug User Fee Act action date of 23 August 2024 has been assigned, indicating the timeline for the FDA's decision regarding the expanded indication. This prioritization underscores the importance of dostarlimab plus chemotherapy as a potential therapy for endometrial cancer and reflects the FDA's commitment to expediting the approval process for promising treatments in areas of unmet medical need.

The acceptance of the sBLA is supported by compelling data from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating statistically significant and clinically meaningful benefits in the overall patient population treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone. Notably, RUBY Part 1 is the first clinical trial to demonstrate a statistically significant survival benefit in the overall patient population. Additionally, the safety and tolerability analysis from RUBY showed a safety profile consistent with the known profiles of the individual agents, further supporting the potential of dostarlimab plus chemotherapy as a well-tolerated treatment option for endometrial cancer patients.

Overall, the acceptance of the sBLA for dostarlimab plus chemotherapy represents a significant advancement in the field of cancer immunotherapy, particularly for the treatment of endometrial cancer. If approved, this combination therapy has the potential to provide a clinically meaningful survival benefit to a broader spectrum of patients with primary advanced or recurrent endometrial cancer, addressing a critical unmet medical need in oncology.

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