A new Phase I-II clinical trial for non-Hodgkin lymphoma (NHL) patients will evaluate the combination therapy of PD-1 immune checkpoint inhibitor nivolumab (Opdivo) and the oral BTK inhibitor ibrutinib (Imbruvica). The announcement was given by Bristol-Myers Squibb and Janssen Biotech, co-developing ibrutinib with Pharmacyclics.
The trial will be performed in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL).
Peter F. Lebowitz, MD, PhD, Global Oncology Head, at Janssen Biotech commented in a Bristol-Myers press release, “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. 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.”
In previous early phase clinical trials, both agents administered separately demonstrated efficacy in treating patients with hematologic malignancies, thus its combined therapy is a promising therapeutic strategy for patients suffering from this type of cancers.
Earlier this year, FDA granted nivolumab “breakthrough therapy” designation, to treat patients with Hodgkin lymphoma that failed autologous stem-cell transplant and brentuximab vedotin (commercialized as Adcetris, an immune-therapy for relapsed Hodgkin lymphoma and relapsed systemic anapaestic large cell lymphoma).
Currently, nivolumab is under evaluation in a Phase II clinical trial for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma that failed autologous stem-cell transplant. Nivolumab was also approved for treatment of patients with non-small cell lung cancer (NSCLC), melanoma and renal cell carcinoma.
Ibrutinib is an approved therapeutic for mantle cell lymphoma (MCL) and chronic lymphocytic leukemia treatment, and for CLL patients with a deleterious mutation in chromosome 17. Ibrutinib has also been evaluated to treat other blood cancers including CLL, MCL, Waldenström’s macroglobulinemia, DLBCL, FL, and multiple myeloma, either alone or in combination with other therapies.
Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb added in the press release, “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.”