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FDA Expands Approval of GSK’s Jemperli for Endometrial Cancer Treatment

NextEdge Admin

02 Aug 2024

1 min 48 sec

Endometrial Cancer,Oncology,immune checkpoint inhibitors

GSK plc announced that the US FDA has approved Jemperli (dostarlimab) combined with carboplatin and paclitaxel chemotherapy, followed by Jemperli alone, for treating adult patients with primary advanced or recurrent endometrial cancer. This approval extends to patients with mismatch repair proficient (MMRp) and microsatellite stable (MSS) tumors, who make up 70-75% of endometrial cancer cases and have limited treatment options. The approval was based on results from the RUBY phase III trial, which demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS). Patients receiving Jemperli plus chemotherapy showed a 31% reduction in risk of death and a 16.4-month improvement in median OS compared to chemotherapy alone. The safety profile was consistent with known effects of the individual agents.

Dr. Matthew Powell highlighted the expanded approval's impact on treatment outcomes, marking a significant advancement in endometrial cancer care.

Adrienne Moore, President of ECANA, emphasized the hope this new treatment brings to patients and their families.

Jemperli, a PD-1-blocking antibody, continues to be a key component in GSK’s immuno-oncology research, with ongoing trials in various cancers aiming for transformative results.