During a planned early futility analysis, the independent Data Monitoring Committee found, based on preliminary data in an all comer population, that the addition of PEGPH20 given every two weeks to modified FOLFIRINOX would be unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to modified FOLFIRINOX alone. Halozyme is working with SWOG to verify and analyze the initial data set, including a planned analysis by hyaluronan (HA) level, following completion of retrospective determination of tumor HA levels.
“We see every clinical trial involving PEGPH20 as a possibility to advance the study and understanding of how to treat patients with some of the most difficult cancers,” said Dr. Helen Torley, president and CEO. “We will work with SWOG to better understand these data and the patients who may best benefit from the addition of PEGPH20.”
Halozyme and its collaboration partners have ongoing studies to evaluate PEGPH20 in combination with chemotherapies and immunotherapies in pancreatic, gastric, lung and breast cancers, with plans to initiate additional combination studies in pancreatic, gastric, gall bladder and bile duct cancers later this year.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies, and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.