Merck commences TH-302 Phase 3 study in pancreatic adenocarcinoma patients

The commencement of the study trigered a $30m milestone payment to Threshold Pharmaceuticals from Merck under a license and co-development agreement signed between the companies.

Randomized, placebo-controlled Phase 3 MAESTRO study is designed to assess the efficacy and safety profile of TH-302 in combination with gemcitabine in pancreatic adenocarcinoma patients.

Threshold Chief Executive Officer Barry Selick said the commencement of the Phase 3 MAESTRO study has advanced the development of TH-302 to treat cancer patients.

"This marks the second Phase 3 study of TH-302 in addition to the ongoing Phase 3 pivotal trial in patients with soft tissue sarcoma," Selick added.

TH-302 in combination with gemcitabine will be compared with placebo plus gemcitabine in around 660 patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma.

The primary efficacy endpoint of the study is overall survival.

Secondary endpoints are efficacy measured by progression-free survival, overall response rate and disease control rate, as well as assessments of safety and tolerability, pharmacokinetics and biomarkers.