AnaptysBio, Inc. announced that GSK's RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial of JEMPERLI (dostarlimab) plus standard of care chemotherapy compared to chemotherapy plus placebo in patients
with primary advanced or recurrent endometrial cancer, met its primary endpoint of invetigator-assessed progression-free survival (PFS). The JEMPERLI regimen showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroup. While the overall survival (OS) data were immature at the time of this analysis, a favorable trend was observed in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups. The safety and tolerability profile of dostarlimab plus chemotherapy was consistent with clinical trials of similar regimens. Regulatory submissions based on the trial results are anticipated in the first half of 2023.