Ono Pharma Announces Oral Presentation of New Data from the Phase 2 Clinical Study of ONO-4578 (EP4 antagonist) in Certain Gastric Cancers at the ASCO 2026 Annual Meeting
ONO-4578, an EP4 antagonist, in combination with OPDIVO® and chemotherapy demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to the placebo combination group (median PFS, 9.0 months vs. 6.9 months, respectively).
In the subgroup population with PD-L1 CPS ≥1, median PFS in the ONO-4578 combination group was 9.9 months, showing a marked clinical benefit compared to 5.7 months in the placebo combination group.
Based on these promising results, preparations are underway to initiate a phase 3 clinical study.
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) today announced the results of the phase 2 clinical study (ONO-4578-08 study) of the EP4 antagonist ONO-4578 in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer). The results were presented at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting.
