After analyzing interim data, Infinity Pharmaceuticals has stopped its phase II study comparing saridegib (IPI-926) in combination with gemcitabine to a placebo plus gemcitabine as treatment for metastatic pancreatic cancer.
While final analysis is not complete, preliminary analysis of data from the study showed a difference in survival favoring the placebo plus gemcitabine arm due to a higher rate of progressive disease in the saridegib plus gemcitabine arm. The median survival for patients receiving saridegib plus gemcitabine was less than the historical median survival for single-agent gemcitabine of approximately six months, as compared to a median survival for the placebo plus gemcitabine arm of greater than six months.
The adverse events observed in both arms were consistent with the known safety profile of each agent, with no unexpected toxicities. Based on this interim analysis, Infinity is voluntarily stopping the trial. The company expects to present the final data after the analyses are complete.
“While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition,” stated Julian Adams, Ph.D., president of R&D at Infinity. “We would like to especially acknowledge the patients and caregivers who have participated in this trial and thank them for their support.”
Infinity is also conducting phase II trials of saridegib as a single agent in myelofibrosis, an incurable malignancy of the bone marrow, and in chondrosarcoma, a rare and life-threatening cancer of the cartilage. Infinity expects to report data from its single-arm, exploratory trial in patients with myelofibrosis in the second half of 2012.