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news.Infinity Pharmaceuticals has reported interim data from its double-blind, randomized, placebo-controlled Phase 2 study comparing saridegib (IPI-926) in combination with gemcitabine to placebo plus gemcitabine in patients with previously untreated, metastatic pancreatic cancer.
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The primary endpoint of the Phase 2 study is overall survival.
A 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 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 the interim analysis, Infinity is voluntarily stopping the trial and expects to present the final data on completion of analyses.