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

Scheduled to be conducted in Japan by Ono and Kyowa Hakko Kirin, the trial will focus on evaluating the safety, tolerability and anti-tumour activity of combining Opdivo, a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody.

In September, Opdivo was launched in Japan for the treatment of patients with unresectable melanoma and the drug is currently being developed in multiple tumour types in more than 50 clinical trials worldwide.

In May 2012, mogamulizumab was launched in Japan to treat relapsed or refractory CCR4-positive Adult T-cell Leukemia-Lymphoma (ATL), and was 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 trial will focus on evaluating the safety, tolerability and anti-tumour activity of combining Opdivo and mogamulizumab."

Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.

Both opdivo and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer.

Ono Pharmaceutical member of the Board of Directors, vice-president executive officer/ executive director, Clinical Development & Clinical Development Planning Hiroshi Awata said: "Studying combination regimens of immunotherapies offers the opportunity to explore the potential of enhanced efficacy compared to current standards of care in treating cancer.

"We are delighted to be able to pursue the possibility of immunotherapies through this collaboration with Kyowa Hakko Kirin.

"We believe that there is a strong rationale to explore the combination of Opdivo and mogamulizumab with the goal of identifying a new treatment option for these cancer patients."

Opdivo binds to the checkpoint receptor PD-1 expressed on activated T-cells, blocking this pathway and allowing the immune system to attack tumours, while mogamulizumab can suppress some of the immune cells that shield the tumour from the immune system.

According to pre-clinical trials, the combination of Opdivo and mogamulizumab may lead to an improved anti-tumour immune response compared to either agent alone.

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."