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Bristol-Myers, Ono and Kyowa Hakko enter immuno-oncology clinical collaboration

Bristol-Myers Squibb, Ono Pharmaceutical and Kyowa Hakko Kirin have entered into a clinical trial collaboration agreement to carry out a Phase I combination trial with Opdivo (nivolumab) and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.

Ono and Kyowa Hakko Kirin will be responsible for conducting the trial in Japan, which will focus on evaluating the safety, tolerability and anti-tumor activity of the combination in these patients.

Opdivo was launched in Japan in September 2014 to treat patients with unresectable melanoma and the drug is currently being developed in multiple tumor types in over 50 clinical trials across the world.

Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "Our collaboration with Kyowa Hakko Kirin further complements the broad clinical development program for Opdivo, will advance our understanding of the combination of Opdivo and mogamulizumab, and is an example of our commitment to develop combination immuno-oncology regimens for patients with metastatic cancer."

In May 2012, mogamulizumab was launched in Japan to treat relapsed or refractory CCR4-positive Adult T-cell Leukemia-Lymphoma (ATL).

The drug was also granted the indication expansion in March 2014 for relapsed or refractory CCR4-positive Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL).

The company said that clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.