Threshold:Two Phase 3 Studies Evaluating Evofosfamide Did Not Meet Primary Goals

(RTTNews) - Threshold Pharmaceuticals, Inc. (THLD) Monday reported the outcomes of two Phase 3 cancer studies - MAESTRO and TH-CR-406/SARC021 - of evofosfamide, previously known as TH-302, an investigational hypoxia-activated prodrug.

It was being evaluated for first-line treatment of advanced pancreatic adenocarcinoma and advanced soft tissue sarcoma, in combination with chemotherapy.

The Phase 3 studies are being conducted under Threshold's collaboration with Merck KGaA.

In the Phase 3 MAESTRO study, patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with evofosfamide in combination with gemcitabine did not demonstrate a statistically significant improvement in overall survival compared with gemcitabine plus placebo.

In the Phase 3 TH-CR-406/SARC021 study being conducted in collaboration with the Sarcoma Alliance for Research through Collaboration, patients with locally advanced unresectable or metastatic soft tissue sarcoma treated with evofosfamide in combination with doxorubicin did not demonstrate a statistically significant improvement in overall survival compared with doxorubicin alone.

Patient safety was monitored in MAESTRO and TH-CR-406/SARC021 by independent data monitoring committees throughout the conduct of each study. No new clinically significant safety findings were observed.

Detailed results from both studies will be submitted for presentation at upcoming international scientific meetings and for publication in peer-reviewed journals. Threshold will not be pursing further development of evofosfamide in soft tissue sarcoma and pancreatic cancer.