FDA Approves Broader Label for GSK’s Jemperli in First-Line Endometrial Cancer

FDA Approval: The FDA has approved dostarlimab-gxly (Jemperli) in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer, regardless of biomarker status.
Expanded Indication: This approval broadens the previous indication to include patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors, which represent 70-75% of endometrial cancer cases.
Clinical Trial Data: The approval is supported by data from the Phase III RUBY trial, which demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) for patients treated with the Jemperli-based regimen compared to chemotherapy alone.
Survival Benefits: The Jemperli combination showed a 31% reduction in the risk of death and a median OS improvement of 16.4 months compared to chemotherapy alone.
Adverse Reactions: Common adverse reactions include anemia, increased creatinine, peripheral neuropathy, and immune-mediated adverse reactions similar to those previously reported for dostarlimab-gxly.
Competitive Landscape: Jemperli now competes with Merck's Keytruda, which also received a broad label expansion for endometrial cancer, but Jemperli retains a competitive edge with its overall survival data.
Dosage and Administration: The recommended dose is 500 mg every 3 weeks for 6 cycles with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.