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Infinity Reports Update from Phase 2 Study of Saridegib Plus Gemcitabine in Patients with Metastatic Pancreatic Cancer

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced interim data from its double-blind, randomized, placebo-controlled Phase 2 study comparing saridegib (also known as IPI-926) in combination with gemcitabine to placebo plus gemcitabine in 122 patients with previously untreated, metastatic pancreatic cancer. The primary endpoint of the Phase 2 study is overall survival.

While the final analysis is not complete, a preliminary analysis of data from the study that was completed yesterday 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 months1,2, 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. As the Hedgehog pathway plays distinctly different biological roles in myelofibrosis and chondrosarcoma, our Phase 2 trials in these disease settings are ongoing,” stated Julian Adams, Ph.D., president of research and development at Infinity. “We would like to especially acknowledge the patients and caregivers who have participated in this trial and thank them for their support.”

Posted-In: News FDA

 

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