Pharmacyclics and Roche have entered into a clinical drug supply agreement to evaluate the safety, tolerability and preliminary efficacy of Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) in patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
Imbruvica is an oral Bruton’s tyrosine kinase (BTK) inhibitor that is being jointly developed and commercialised by Pharmacyclics and Janssen Biotech. Gazyva is a new CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system.
Pharmacyclics will initially conduct a Phase III trial of the combination in CLL/SLL patients, and plans to evaluate the combination to treat NHL patients are currently under development.
According to the company, the two products are approved and marketed for the treatment of CLL.
Imbruvica is indicated for CLL patients who have received one prior therapy, as well as patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.
Gazyva, in combination with chemotherapy drug chlorambucil is used to treat CLL in patients with previously untreated chronic lymphocytic leukemia.
Pharmacyclics CEO Bob Duggan said: "We are committed to evaluating the potential activity of Imbruvica as a single agent and in combination with other agents to determine the benefits that Imbruvica may provide through a variety of uses across several hematologic malignancies.
"We look forward to a rewarding and productive partnership with Roche to evaluate our product with Gazyva in order to deliver new treatment options to patients with NHL and CLL."
The Phase III trial of the investigational combination of Imbruvica and Gazyva through several investigator-sponsored trials is also being considered.
Imbruvica is currently being evaluated alone and in combination with other treatments in several blood cancers including CLL, MCL, Waldenstrom’s macroglobulinemia (WM), DLBCL, FL and multiple myeloma (MM).