AbbVie issued the following announcement on May 24.
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Phase 3 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 U.S. Food and Drug Administration (FDA)-approved for treatment in six disease indications. IMBRUVICA has the longest follow-up data as a BTK therapy in CLL.1
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.
"We are optimistic about the topline results from the iLLUMINATE study and the fact that IMBRUVICA plus obinutuzumab demonstrated marked improvement in progression-free survival compared to obinutuzumab plus chlorambucil, a combination which is currently recommended by the National Comprehensive Cancer Network guidelines as a Category 1 treatment,"2 said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. "Since its introduction nearly five years ago, IMBRUVICA has been regarded as an important treatment option for patients with CLL/SLL. As well, we now have long-term, five-year data in CLL. We are committed to researching the full potential of IMBRUVICA alone and in combination therapy across a range of B-cell blood cancers."
"We're pleased to see positive results for the combination of ibrutinib plus obinutuzumab. This chemotherapy-free combination represents a potential new treatment option for patients with chronic lymphocytic leukemia," said John Gribben, M.D., leading investigator for the iLLUMINATE study and Professor of Medical Oncology, Barts Cancer Institute, London, United Kingdom. "It's exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients."
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.4 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.5 CLL/SLL are predominately diseases of the elderly, with a median age of 71 at diagnosis.
Original source can be found here.
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