Phase III iLLUMINATE trial report of Imbruvica + Gazyva combination for chronic lymphocytic leukemia or small lymphocytic lymphoma.- Abbvie + Janssen Biotech

AbbVie has announced that the Phase III iLLUMINATE (PCYC-1130) trial met its primary endpoint of improvement in progression-free survival (PFS). The study evaluated Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) patients, the most common adult leukemia. Specifically, the study met its primary endpoint for a clinically and statistically significant difference in PFS for patients treated with Imbruvica plus obinutuzumab versus those who received chlorambucil plus obinutuzumab, as assessed by an Independent Review Committee (IRC). Imbruvica is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. Imbruvica has been available in the U.S. since November 2013 and is FDA-approved for treatment in six disease indications. Imbruvica has the longest follow-up data as a BTK therapy in CLL. Pharmacyclics and Janssen are sharing the primary analysis data from the study with regulatory authorities and plan to present the data in a future publication or medical congress.

Based on the data and if approved by the FDA, Imbruvica plus obinutuzumab could be the first chemotherapy-free CD20 combination in first-line CLL treatment. CLL is the most common form of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). While these cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S.3 with approximately 19,000 newly diagnosed patients every year. SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal. CLL/SLL are predominately diseases of the elderly, with a median age of 71 at diagnosis.