Threshold Pharmaceuticals, Inc. (THLD) announced updated results from a Phase 2 study of TH-302, the company's investigational hypoxia-targeted drug, in patients with soft tissue sarcoma, including additional results from patients who were administered TH-302 as single agent maintenance therapy following induction with TH-302 in combination with doxorubicin.
In the single-arm Phase 2 component of the study, previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcomas were treated with TH-302 and doxorubicin for a maximum of six cycles. After six cycles, patients with stable disease, partial or complete responses, and with acceptable toxicity, were eligible to receive TH-302 maintenance therapy. Response was assessed using RECIST criteria.
In overall study population, results for the 91 patients in the Phase 2 component of the study include median progression free survival of 6.7 months, median overall survival of 21.5 months, one-year survival of 73% and two-year survival of 44% and overall best response of 36%.
The company also reported results for TH-302 single agent maintenance therapy population. The median number of treatment cycles with TH-302 was 4.0. Median PFS was 3.7 months. Median overall survival was 18 months. Overall best response was 54%.
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