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Threshold Pharmaceuticals Inc Announces Data From Phase 2b Clinical Trial Of TH-302 In Combination With Gemcitabine In Advanced Pancreatic Cancer

Monday, 17 Sep 2012 03:00am EDT 

Threshold Pharmaceuticals Inc announced that data from a randomized open-label Phase 2b clinical trial of investigational hypoxia-targeted drug TH-302 in patients with advanced pancreatic cancer. The Company announced in February 2012 that study met primary endpoint demonstrating a statistically 63% improvement (p=0.005) in progression free survival (PFS) for patients treated with TH-302 and gemcitabine versus gemcitabine alone. This represented a 2-month increase in PFS for patients treated with TH-302. New findings on overall survival, which was a secondary endpoint of the study, indicate that patients treated with gemcitabine alone had a median overall survival of 6.9 months compared with 9.2 months for patients treated with 340 mg/m2 TH-302 plus gemcitabine (HR: 0.955, 95% CI: 0.67-1.37, p=0.800) and 8.7 months for patients treated with 240 mg/m2 TH-302 plus gemcitabine (HR: 0.960, 95% CI: 0.67-1.38, p=0.827). While not statistically, improvement in median overall survival is consistent with improvement in median PFS reported previously. The trial was not designed to detect a statistically improvement in overall survival and included a cross-over component. Patients receiving gemcitabine alone who crossed over to receive gemcitabine plus TH-302 upon disease progression did contribute to an increase in survival of the control arm. 

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30 Jul 2014