Bristol-Myers Squibb, Pharmacyclics, Janssen Partner To Evaluate Opdivo, Imbruvica In Non-Hodgkin Lymphoma

Bristol-Myers Squibb (BMS), Pharmacyclics, and Janssen have partnered to evaluate BMS’ drug, Opdivo (nivolumab), in combination with Pharmacyclics’ and Janssen’s Imbruvica (ibrutinib) for patients with non-Hodgkin lymphoma (NHL). The clinical trial collaboration, announced in a press release, is for a Phase 1/2 study of the anti-tumor activity of the combined agents. BMS recently announced two other collaborations to study Opdivo in hematologic malignancies and in non-small cell lung cancer (NSCLC).

Michael Giordano, senior VP at Bristol-Myers Squibb, said, “We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas.”

Bristol-Myers Squibb, Pharmacyclics, Janssen Agreement

Janssen and Pharmacyclics entered into a partnership agreement in 2011 to jointly develop and commercialize Imbruvica. The new agreement with BMS calls for Janssen to conduct the clinical trial of Opdivo and Imbruvica. The study will include patients with NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL).

Bob Duggan, Chairman and CEO of Pharmacyclics, stated that his company values its collaboration with Janssen and looks forward to an equally rewarding relationship with BMS. The companies did not disclose the financial terms of the agreement.

Opdivo

Opdivo is the proposed trade name for nivolumab, an immunotherapy that targets regulatory components of the immune system to help the body fight cancer. Opdivo is a fully-human PD-1 (programmed death-1) immune checkpoint inhibitor that helps flush out cancer cells, stopping them from hiding from the immune system. BMS is studying the investigational agent in 35 trials with 7,000 people with small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, and glioblastoma.

Imbruvica

Imbruvica (ibrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor. The oral therapy inhibits the signaling protein in the B-cell receptor signal complex that plays a role in malignant B cell proliferation. Imbruvica is approved to treat patients with chronic lymphocytic leukemia CLL and those with mantle cell lymphoma (MCL). The current development program for Imbruvica includes seven clinical trials investigating various drug combinations and their efficacy against several types of cancers.

Since both Opdivo and Imbruvica have shown efficacy against hematologic malignancies and pre-clinical evidence has indicated efficacy in combination, the upcoming Phase 1/2 trial may prove successful, or at least add to the body of knowledge about the two agents.