AnaptysBio, GSK announces Phase 3 RUBY trial results for JEMPERLI

AnaptysBio (ANAB) announced that GSK's (GSK) RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial of JEMPERLI plus standard of care chemotherapy compared to chemotherapy plus placebo in patients with primary advanced or recurrent endometrial cancer, met its primary endpoint of investigator-assessed progression-free survival. The JEMPERLI regimen showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient/microsatellite instability-high patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient/microsatellite stable patient subgroup. While the overall survival 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. GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting. "We are encouraged to see AnaptysBio-discovered molecules continue to deliver differentiated outcomes for patients in indications with substantial unmet need. We are grateful to our partners at GSK for enabling broad development of JEMPERLI and to the patients in the RUBY and other JEMPERLI trials for their participation," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We believe that potential first-in-class approvals for JEMPERLI in endometrial cancer and other indications could over time materially contribute to our strong capital position as we focus on the R&D of our immune cell modulator pipeline. This includes our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA agonist, which act directly on cell types mediating disease pathology and have the potential to treat a broad range of autoimmune and inflammatory disorders."