Ono Pharmaceutical’s EP4 antagonist hit the primary progression-free survival endpoint in a phase 2 trial in patients with gastric cancer.
The biopharma evaluated the Bristol Myers Squibb-partnered candidate, dubbed ONO-4578, in combination with the PD-1 blocker Opdivo and chemotherapy in patients in Japan, South Korea and Taiwan with HER2-negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer.
The study tied this combo treatment regimen to a statistically significant prolongation of progression-free survival when compared to placebo, hitting the trial’s primary endpoint.
Ono didn’t share any data in the sparse press release, promising to unveil the findings at future academic meeting.
The selective prostaglandin E2 receptor 4 antagonist is aimed at targeting immunosuppressive factors in the tumor microenvironment. Japan-based Ono reaffirmed today that it is conducting several other trials of ONO-4578, including a global phase 2 study in patients with colorectal cancer.
Ono codeveloped Opdivo with BMS, and the Japanese biopharma scored its own FDA approval earlier this year for Romvimza to treat a type of noncancerous growth.
BMS spotted ONO-4578’s potential back in 2017, when the U.S. pharma paid $40 million upfront for the rights to the drug outside of Japan, South Korea, Taiwan, China and Association of Southeast Asian Nations (ASEAN) countries.
Under the terms of that deal, BMS and Ono have partnered on developing ONO-4578 in Japan, South Korea and Taiwan under the two companies’ longstanding collaboration agreement. In China and ASEAN countries, Ono retained the exclusive rights.
“To improve long-term outcomes for more patients with cancer, we believe more immuno-oncology based combinations may be required, and we are pleased to continue our long-standing collaboration with Ono with this focus in mind,” BMS explained at the time.