ONO-4578, an EP4 antagonist partnered with Bristol-Myers Squibb (BMS), demonstrated a statistically significant prolongation of progression-free survival (PFS) in a Phase 2 trial for previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer)167.
The study compared ONO-4578 in combination with Opdivo (nivolumab) and chemotherapy vs. placebo plus Opdivo and chemotherapy, with the ONO-4578-based triplet meeting the primary endpoint on PFS167.
The trial was conducted in Japan, South Korea, and Taiwan, and Ono Pharmaceutical plans to publish detailed results at a future academic meeting16.
No new safety concerns were identified in the trial, supporting further development of the combination regimen6.
ONO-4578 is part of a broader partnership strategy to explore immuno-oncology combinations for improved long-term outcomes in gastric cancer1.
Sources:
1. https://www.fiercebiotech.com/biotech/onos-bms-partnered-ep4-antagonist-improves-survival-phase-2-gastric-cancer-trial