Bristol-Myers Squibb (BMS) and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, BMS and Ono will jointly develop and commercialise Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumour types.
Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is being developed in multiple tumor types in more than 35 clinical trials. Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan for the treatment of patients with advanced melanoma who have received prior therapy, and is in late-stage development as a potential treatment option for melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan. The agreement includes three additional early-stage clinical immuno-oncology assets from BMS: lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor.
BMS and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.
“BMS’s collaboration with Ono supports our goal to maximise the full potential of our immuno-oncology portfolio for patients worldwide,” said Lamberto Andreotti, chief executive officer, BMS. “This collaboration combines our leadership in immuno-oncology with both companies’ experience and capabilities in Asia, and strengthens our long-standing relationship with Ono.”
“Our collaboration with BMS strengthens our ability to further enhance the potential of Opdivo, for which Ono recently received manufacturing and marketing approval in Japan as the first PD-1 inhibitor approved anywhere in the world,” said Gyo Sagara, president, representative director and CEO, Ono. “By pursuing the study of investigational combination regimens of immunotherapies with BMS, we hope to bring a range of new therapeutic options to cancer patients.”