Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) and Bristol-Myers Squibb Company have entered into a clinical trial collaboration agreement to conduct a phase 1/2 combination study with mogamulizumab, an anti-CCR4 antibody and Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor.

The study, which will be conducted in the US, will focus on evaluating the safety, tolerability and anti-tumour activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumours. Prior to this agreement, Kyowa Hakko Kirin, Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan.

Mogamulizumab and Opdivo 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 by targeting distinct regulatory components of the immune system.

“We are pleased to conduct a combination study with Bristol-Myers Squibb not only in Japan but also in the US,” said Yoichi Sato, director of the board managing executive officer, vice president, head of research and development division of Kyowa Hakko Kirin. “We believe that the planned combination of these two immunotherapies has the potential to deliver better outcomes in patients with advanced cancers than existing treatments.”

“Today’s agreement builds on our initial collaboration with Kyowa Hakko Kirin in Japan, which includes our partner Ono Pharmaceutical Co., Ltd., and is the latest example of our continued commitment to evaluating the potential of combination immuno-oncology regimens for patients with metastatic cancer,” stated Michael Giordano, senior vice president, head of development, oncology, Bristol-Myers Squibb.

The study will be conducted by Kyowa Hakko Kirin.

Mogamulizumab (Poteligeo) is a novel, humanized mAb directed against CC chemokine receptor type 4 (CCR4). Engineered by Kyowa Hakko Kirin's unique Potelligent technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity. Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014, and with chemotherapy-native CCR4-positive ATL in December 2014. Clinical trials with mogamulizumab are ongoing in the US, EU and other countries.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the US.Food and Drug Administration (FDA) as a monotherapy in two cancer indications. On March 5, 2015, Opdivo received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

In the US, Opdivo is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.

The most common adverse reactions (=20 per cent) reported with OPDIVO in Trial 1 were rash (21 per cent) and in Trial 3 were fatigue (50 per cent), dyspnea (38 per cent), musculoskeletal pain (36 per cent), decreased appetite (35 per cent), cough (32 per cent), nausea (29 per cent), and constipation (24 per cent).

Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology and immunology/allergy.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.