AbbVie 'RESOLVEs' to deal with pancreatic cancer

Company provides update on Phase 3 clinical trial of ibutinib in combo with chemo agents

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NORTH CHICAGO, Ill.—Pharma companies shoot for big goals in many cases, trying to fight back or cure some of the most vexing diseases, like cancer. And people often set ambitious goals on New Year’s Day, resolving to make big changes in their lives, though many tend to break those resolutions before January is even over. So it is both ironic and somehow sadly fitting that in January, AbbVie’s trial titled RESOLVE ended up falling short of expectations with regard to treating pancreatic cancer.
What the RESOLVE trial aimed for was attacking metastatic pancreatic cancer, one of the most aggressive and deadliest forms of cancer, which has an estimated five-year survival of less than 5 percent. Specifically, AbbVie was looking to do so by evaluating Imbruvica (ibrutinib) in combination with the chemotherapy agents nab-paclitaxel and gemcitabine vs. placebo in combination with these chemotherapy agents.
However, while the Bruton’s tyrosine kinase (BTK) inhibitor (jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc.) has been available in the U.S. since 2013 and is FDA-approved for nine indications in six disease areas, including five B cell blood cancers and chronic graft-versus-host-disease, it did not show statistically significant progression-free survival (PFS) or overall survival (OS) benefit in this case.
PCYC-1137 evaluated the efficacy of Imbruvica in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer. Patients were randomized 1:1 to receive ibrutinib and nab-paclitaxel and gemcitabine combination treatment arm (n=211 study patients) vs. the placebo and nab-paclitaxel and gemcitabine combination treatment arm (n=213 study patients). At conclusion, the study did not meet its primary endpoint of improving PFS or OS benefit among the study population. Safety data collected from the study were consistent with the existing safety information for the study therapies. The full results from this trial will be submitted for publication to a future scientific conference and/or a peer-reviewed medical journal.
Of course, this doesn’t mean that the company will stop looking for new ways to employ Imbruvica.
“We continue to evaluate the potential of Imbruvica as a cancer treatment alone or in combination for a variety of cancer types. We are passionately advancing our robust ibrutinib scientific development program to continue to advance cancer standards of care, particularly in areas that have unmet medical need,” said Dr. Danelle James, head of clinical science operations at Pharmacyclics.
Imbruvica is a part of more than 130 ongoing clinical trials, and is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 135,000 patients around the world have been treated with Imbruvica in clinical practice and clinical trials.
In more upbeat AbbVie news from January, the company announced a couple weeks earlier that it and Tizona Therapeutics Inc., a privately held immunotherapy company, had entered into a global, strategic collaboration to develop and commercialize CD39-targeted therapeutics, including TTX-030, a first-in-class antibody for the treatment of cancer.
According to AbbVie, the ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment (TME) by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway.
“Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment,” commented Dr. Mo Trikha, an AbbVie vice president and head of the oncology early development program at the company. “Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody.”
“Tumors employ various strategies to create a tolerogenic microenvironment, which reduces the immune system’s ability to detect and fight cancer,” added Dr. Courtney Beers, vice president of immunology at Tizona. “Preclinical research shows that inhibiting CD39 may hold the key to restoring and bolstering immune responses against tumors. In AbbVie, we have a partner who shares our passion for science and commitment to delivering breakthrough innovation to patients with cancer. We look forward to advancing this exciting program.”
Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona will lead clinical development through completion of Phase 1b studies, after which AbbVie has an exclusive option to lead global development and commercial activities. In addition, Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

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