Bristol-Myers Squibb (BMS) and Kyowa Hakko Kirin Co., have formed a clinical trial collaboration agreement to conduct a Phase I/II combination study with Kyowa’s mogamulizumab, an anti-CCR4 antibody and BMS’s Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor. The study, which will be conducted in the US by Kyowa, will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. Prior to this agreement, Kyowa Hakko Kirin, BMS, and Ono Pharmaceutical Co., Ltd. formed 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.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor type 4 (CCR4). 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 and cutaneous T-cell lymphoma 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 treating metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. In the US, Opdivo is also indicated for treating unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo was first approved in July 2014 in Japan for treating unresectable melanoma. BMS has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials, as both a monotherapy or in combination with other therapies, in which more than 7,000 patients have been enrolled worldwide.

Source: Bristol-Myers Squibb