BMS, Pharmacyclics, Janssen Enter OPDIVO Clinical pact

Bristol-Myers Squibb, Pharmacyclics, Inc., and Janssen R&D, LLC have entered a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor OPDIVO (nivolumab) in combination with IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. Additional details were not disclosed.

Janssen will conduct the Phase 1/2 study evaluating the safety and anti-tumor activity of OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). BMS has proposed the name OPDIVO, which if approved, will serve as the trademark for the investigational drug, nivolumab.

OPDIVO is 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 components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials, suggesting OPDIVO and IMBRUVICA may have the potential for additive treatment effects in hematologic malignancies.

“Our collaboration to study OPDIVO in combination with IMBRUVICA is an innovative approach to accelerating Bristol-Myers Squibb’s progress in the study of immuno-oncology and hematologic malignancies, gaining further insight into promising areas of drug development and research,” said Michael Giordano, senior vice president, head of development, Oncology, Bristol-Myers Squibb. “We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas.”

“We are excited about the opportunity to understand and evaluate the potential activity of IMBRUVICA and OPDIVO together, and the benefits this combination may offer patients,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “We look forward to working with Bristol-Myers Squibb and Pharmacyclics on this study as we continue to grow the body of knowledge about IMBRUVICA in different settings and patient populations.”

“This collaboration underscores our interest in exploring the use of IMBRUVICA in combination with other therapies to address a variety of histologies in which we believe IMBRUVICA can make a meaningful clinical difference,” said Bob Duggan, chairman and chief executive officer, Pharmacyclics. “We value our strategic collaboration with Janssen and look forward to extending our relationship to Bristol-Myers Squibb for this project as our companies collectively seek to advance treatment options for patients.”