Halozyme Therapeutics announced it has been informed by SWOG, an independent network of researchers that design and conduct cancer clinical trials, that the SWOG Phase 1b/2 trial evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed to enrollment.
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.
Filed Under: Drug Discovery