Pharmaceutical Business review

Merrimack begins Phase II trial of MM-141 to treat pancreatic cancer

The randomized, double-blinded, placebo-controlled trial will be conducted at sites in the US, Canada and Europe.

The trial is designed to evaluate MM-141 in combination with nab-paclitaxel and gemcitabine, versus nab-paclitaxel and gemcitabine alone to treat patients with newly-diagnosed metastatic pancreatic cancer who have high serum levels of free IGF-1.

Merrimack medical director of MM-141 Dr Chrystal Louis said: "Pancreatic cancer is the fourth leading cause of cancer death in the US and is projected to rise to the second leading cause by 2020.

"Data from our Phase 1 trial supports further clinical evaluation of MM-141 in patients with high serum levels of free IGF-1. Patients with this biomarker profile may have the greatest potential of benefit from the use of MM-141 combined with standard chemotherapies, and we look forward to further validating this in our Phase 2 trial."

In the trial, 146 front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1 will be randomized 1:1 to receive either MM-141 plus nab-paclitaxel/gemcitabine or nab-paclitaxel/gemcitabine alone.

The company said that eligible patients must have received no prior radiotherapy, surgery, chemotherapy or investigational therapy to treat metastatic disease.

The trial’s primary endpoint is progression free survival (PFS), while secondary endpoints include overall survival, objective response rate, safety and tolerability.