Bristol-Myers Squibb (BMS), Pharmacyclics and Janssen Research & Development have collaborated to start a Phase I/II clinical trial to assess the safety, tolerability and preliminary efficacy concerning the combination of OPDIVO (nivolumab) and IMBRUVICA (ibrutinib) in patients with non-Hodgkin’s lymphoma (NHL).
OPDIVO is BMS’s investigational PD-1 immune checkpoint inhibitor, while IMBRUVICA is an oral Bruton’s tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.
The trial is designed to evaluate the safety and anti-tumour activity of the combination therapy as a potential treatment option for patients with 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 by health authorities, will serve as the trade name for nivolumab.
BMS senior vice president Michael Giordano said: "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.
"We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas."
OPDIVO is part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system in fighting cancer. Immunotherapies target distinct regulatory components of the immune system in order to combat cancer.
In clinical trials, each agent individually demonstrated activity against hematologic malignancies.
According to pre-clinical evidence, the combination of OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies.
Janssen global oncology head Peter Lebowitz said: "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."
Janssen will be responsible for conducting the Phase I/II trial as part of the clinical trial collaboration agreement.
Pharmacyclics CEO Bob Duggan said: "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.
"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."