Infinity Pharmaceuticals, Inc. Reports Update from Phase 2 Study of Saridegib Plus Gemcitabine in Patients with Metastatic Pancreatic Cancer
January 27, 2012 at 06:45 am
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Infinity Pharmaceuticals, Inc. 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 on Jan. 26, 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 (1,2), 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. Infinity is conducting Phase 2 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 Phase 2 trial of saridegib in up to 45 patients with myelofibrosis in the second half of 2012. The company expects to complete enrollment in its double-blind, randomized, placebo-controlled trial of saridegib in approximately 140 patients with metastatic or locally advanced, unresectable chondrosarcoma in the second half of 2012 and to report data from this trial in the first half of 2013. Infinity has underway six clinical trials across three development programs, including saridegib, retaspimycin HCl (also known as IPI-504), a novel heat shock protein 90 inhibitor, and IPI-145, a potent, oral inhibitor of phosphoinositide-3-kinase delta and gamma. Infinity expects to report data from each of its three development programs in the second half of 2012.
Infinity Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that is focused on developing medicines for people with cancer. The Company is focused on advancing eganelisib, also known as IPI-549, an orally administered, clinical-stage, immuno-oncology product candidate that reprograms macrophages through selective inhibition of the enzyme phosphoinositide-3-kinase-gamma (PI3K-gamma). Its eganelisib clinical development program includes MAcrophage Reprogramming in Immuno-Oncology-3 (MARIO-3), MARIO-275 and MARIO-1. MARIO-3 is a multi-arm Phase II study designed to evaluate eganelisib in the front-line treatment for both metastatic triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC). MARIO-275 is its global, randomized, placebo-controlled Phase II study evaluating the effect of adding eganelisib to nivolumab, also known as Opdivo, in checkpoint-naive advanced urothelial cancer (UC). MARIO-1 is in the Phase I/Ib clinical study.