Infinity Pharmaceuticals has announced interim data from its double-blind, randomized, placebo-controlled Phase II study comparing IPI-926 (saridegib) plus gemcitabine to placebo plus gemcitabine in 122 patients with previously untreated, metastatic pancreatic cancer. The study's primary endpoint is overall survival (OS).
Although final analysis remains incomplete, an examination of the data at this point has proven disappointing to Infinity: Contrary to expectations, data analysis is revealing a difference in survival that favors the placebo plus gemcitabine arm.
A higher rate of progressive disease has been observed in the IPI-926 plus gemcitabine arm, while the median survival for patients receiving IPI-926 plus gemcitabine was less than the historical median survival for single-agent gemcitabine.
Consequently, Infinity has halted the trial.
Said Julian Adams, Ph.D., Infinity's president of research and development, “While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition. We would like to especially acknowledge the patients and caregivers who have participated in this trial and thank them for their support.”
Source: Therapeutics Daily
