Ibrutinib (IMBRUVICA) may be effective for pancreatic ductal adenocarcinoma

Ibrutinib (IMBRUVICA^®) data presented yesterday by Pharmacyclics, Inc. (NASDAQ: PCYC) at the American Association for Cancer Research (AACR) Annual Meeting suggest that ibrutinib may be an effective therapeutic option for pancreatic ductal adenocarcinoma (PDAC), as shown in both a transgenic mouse model and an in-vivo model of patient-derived xenograft (PDX) mice (grafts of tissue taken from a pancreatic cancer patient and grafted into a mouse). These early, pre-clinical data show ibrutinib was associated with potent anti-fibrotic activity and longer survival in the treated mice. PDAC is a type of pancreatic cancer that is typically characterized by a fibro-inflammatory reaction, which makes PDAC a difficult disease to treat with current therapies. These data were also published in the April 15^th edition of Cancer Research. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

"These results are very promising, particularly considering that there is an urgent need for new treatment options for people living with pancreatic adenocarcinoma, an aggressive disease with limited therapies," said Laura Soucek, Ph.D., Principal Investigator for the Mouse Models of Cancer Therapies Laboratory at the Vall d'Hebron Institute of Oncology (VHIO) in Barcelona, Spain and an investigator for the study. "These results are compelling and additional research is needed to determine the therapeutic impact of ibrutinib in patients with pancreatic cancer."

PDAC is the most common form of pancreatic cancer and is often associated with poor prognosis. PDAC is the fourth leading cause of cancer death in the United States, with an average survival time of less than one year after diagnosis. There are approximately 45,000 newly diagnosed patients every year, with the median age of 71 years at diagnosis.

"These promising preclinical data are encouraging due to the poor outcomes currently seen with available therapies," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics. "Novel treatment approaches are needed for this devastating disease and we are encouraged by these preclinical findings suggesting that ibrutinib may have a positive impact on patients with pancreatic adenocarcinoma. We are committed to continuing to investigate the potential utility of IMBRUVICA across multiple histologies, including difficult-to-treat solid tumors."

The study evaluated the use of ibrutinib versus a vehicle control in two different preclinical mouse models of PDAC and found treatment with ibrutinib not only dramatically reduced tumor cell proliferation and inflammatory cell infiltration, but also was associated with reductions in collagen deposition in the stroma of the PDAC mice. The mice treated with ibrutinib also experienced longer survival, particularly when the therapy was used in combination with gemcitabine. Additional clinical research is needed to fully understand the potential benefits of ibrutinib for patients with PDAC.