Currently, the company is conducting an international, randomized Phase III trial of TH-302 in these patients in partnership with the Sarcoma Alliance for Research through Collaboration (SARC) and under a Special Protocol Assessment (SPA) with the FDA.
The trial is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared with doxorubicin alone, in previously untreated patients with metastatic or locally advanced unresectable STS.
Primary endpoint of the trial is overall survival, while secondary endpoints include progression-free survival, overall response rate, pharmacokinetics and safety.
During the trial, patients were randomized to either doxorubicin alone or to receive TH-302 300 mg/m2 administered intravenously on Days 1 and 8 with doxorubicin 75mg/m2 on Day 1 of each 21-day cycle.
A total of 640 patients were enrolled in the trial at about 81 study sites in Europe, Israel, North America and the Russian Federation.
Threshold chief executive officer Barry Selick: "Currently, we anticipate the primary analysis of overall survival of the Phase 3 trial to be conducted in the first quarter of 2016."
Threshold and Merck have a global license and co-development agreement for TH-302, which includes an option for Threshold to co-commercialize the drug in the US.