Merck KGaA has initiated a late-stage trial of its hypoxia-targeted agent TH-302, developed with the USA's Threshold Pharmaceuticals, as a potential treatment for pancreatic cancer.
The Phase III MAESTRO study will evaluate the drug in combination with gemcitabine in patients with previously untreated, locally advanced metastatic pancreatic adenocarcinoma. The primary endpoint of the study, which is expected to enroll 660 patients is overall survival; the trial is being conducted under a special protocol assessment with the US Food and Drug Administration.
The German group quoted Eric Van Cutsem of University Hospitals, Leuven, Belgium and coordinating investigator of the study, as saying that patients with advanced pancreatic cancer "currently have a poor prognosis and limited treatment options". He added that “investigating compounds thought to be activated under tumour hypoxic conditions offers the potential" to expand those options.
TH-302, for which Merck signed a co-development agreement that could be worth over $500 million to Threshold, is already in Phase III for soft tissue sarcoma.
News of the trial comes days after Celgene Corp presented positive but not stunning data on its oncology agent Abraxane (nab-paclitaxel) in combination with gemcitabine for pancreatic cancer. Stifel Nicolaus analyst Joel Sendek issued a research note stating that "a robust Abraxane result could have impeded enrolment" in the MAESTRO trial, but he views the latter's data as "just on the edge of what is considered a clinically meaningful benefit".