Merck

Merck has received fast-track designation from the US Food and Drug Administration (FDA) for its evofosfamide (previously known as TH-302) to treat patients with advanced pancreatic cancer.

The company has obtained fast-track status to develop evofosfamide in combination with gemcitabine to treat previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

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Evofosfamide is an investigational hypoxia-activated prodrug, which is believed to be activated under severe tumour hypoxic conditions, a feature of multiple solid tumours.

Merck biopharmaceutical business global research and development head Luciano Rossetti said: "Merck is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat."

"Merck is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat."

The compound is being developed in partnership with US-based Threshold Pharmaceuticals. With an option for Threshold to co-commercialise in the US, Merck signed a global licence and co-development agreement for evofosfamide with Threshold in February 2012.

In November 2014, Threshold obtained the first fast-track designation to develop evofosfamide in combination with doxorubicin for the treatment of advanced soft tissue sarcoma.

Threshold Pharmaceuticals CEO Dr Barry Selick said: "Evofosfamide is currently being studied in patients with pancreatic cancer in the Maestro Phase III study, and based on current projections, we expect that the number of protocol-specified events for the trial may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter."

Evofosfamide is currently being assessed in two Phase III trials, including one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial).

The other trial is assessing evofosfamide in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the Maestro trial).


Image: Merck has received fast-track status to develop evofosfamide in combination with gemcitabine to treat previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Photo: courtesy of Merck KGaA.