Bristol-Myers Squibb and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize 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.

BMS and Ono will jointly develop and commercialize Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor 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 and Ono will jointly develop and commercialize all collaboration products in Japan, South Korea and Taiwan. Development costs and commercial profits will be shared equally when Opdivo is used in combination with any BMS compound (Yervoy, lirilumab, urelumab, BMS-986016). For a BMS compound used as monotherapy, or two BMS compounds used in a combination regimen, BMS will fund the substantial majority of development costs and receive the substantial majority of commercial profits. When Opdivo is used as a single agent, Ono will fund the substantial majority of development costs and receive the substantial majority of commercial profits.

Previously, Ono held exclusive rights to develop and commercialize Opdivo in Japan, South Korea and Taiwan, while BMS held such rights in the rest of the world, along with sole rights to develop and commercialize Yervoy, lirilumab, urelumab and BMS-986016 worldwide. The trade name Opdivo has been proposed in the U.S. and other countries, but remains subject to health authority approval.