▎WuXiEdited by Kant Content Team

GSK announces that the US FDA has approved Jemperli (dostarlimab) for use in combination with standard chemotherapy (carboplatin-paclitaxel), followed by Jemperli as a monotherapy, for the treatment of all adult patients with primary advanced or recurrent endometrial cancer.This approval expands the indications for Jemperli in combination with chemotherapy to include the treatment of patients with mismatch repair proficient (MMRp) and microsatellite stable (MSS) tumors.Such patients account for 70-75% of those diagnosed with endometrial cancer, and their treatment options are limited.The press release noted that this is the first immuno-oncology treatment to demonstrate an overall survival benefit in this type of patient population.

In Part 1 of the RUBY study,Compared with chemotherapy alone, the risk of death in the patient subgroup treated with Jemperli combined with standard chemotherapy was reduced by 31% (HR: 0.69; 95% CI: 0.54-0.89), with a median OS improvement of 16.4 months (44.6 months vs 28.2 months), which is clinically significant.At 2.5 years, 61% (95% CI: 54-67) of patients in the Jemperli plus chemotherapy group were alive, compared to only 49% (95% CI: 43-55) in the chemotherapy-alone group.

Exploratory analysis results for the MMRp/MSS population showed a 21% reduction in the risk of death (HR: 0.79; 95% CI: 0.602-1.044) and a 7-month improvement in median OS (34.0 months vs 27.0 months), which is clinically significant. Detailed data are shown in the table below.

▲Overall survival data from Part 1 of the RUBY study (Image source: Reference [2])

The safety and tolerability analysis of RUBY Part 1 showed that the safety of Jemperli in combination with chemotherapy was generally consistent with the known safety profiles of the individual drugs. The most common treatment-related adverse events (≥20%) were nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea, myalgia, rash, hypomagnesemia, decreased appetite, peripheral sensory neuropathy, and vomiting.

Jemperli is an antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.In the treatment of endometrial cancer, Jemperli has been approved by the U.S. FDA for use after prior platinum-containing therapy.Mismatch Repair Deficiency (dMMR)Monotherapy for advanced or recurrent endometrial cancer.In July 2023, the U.S. FDAApprovalFor Jemperli in combination with carboplatin and paclitaxel, followed by Jemperli monotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer determined to be dMMR or microsatellite instability-high (MSI-H) by an FDA-approved test.