Gilead reports Phase II trial results of pancreatic cancer drug simtuzumab

17th September 2014 (Last Updated September 17th, 2014 18:30)

Gilead Sciences has reported results from a Phase II trial of simtuzumab in patients with previously untreated advanced pancreatic cancer.

Gilead Sciences has reported results from a Phase II trial of simtuzumab in patients with previously untreated advanced pancreatic cancer.

In this trial, simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), was evaluated in combination with gemcitabine in these patients.

LOXL2 is an enzyme that modifies the extracellular matrix by promoting the cross-linking of collagen fibers.

The trial showed that the addition of simtuzumab (200mg or 700mg) to gemcitabine did not significantly increase progression-free survival (PFS) compared to placebo plus gemcitabine.

"We continue to explore simtuzumab in other areas of unmet medical need, with ongoing clinical trials in colorectal cancer, myelofibrosis and serious fibrotic lung and liver diseases."

PFS was the primary endpoint of the randomised, double-blind, placebo-controlled Phase II trial.

In the trial, a total of 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab or placebo in cycles of 28 days.

The company said that median PFS for the simtuzumab 200mg, simtuzumab 700mg and placebo groups was 3.5 months, 3.7 months and 3.7 months, respectively.

Gilead executive vice-president of research and development and chief scientific officer Norbert Bischofberger said: "Although simtuzumab did not provide clinical benefit in difficult-to-treat advanced pancreatic cancer patients in this study, we continue to explore simtuzumab in other areas of unmet medical need, with ongoing clinical trials in colorectal cancer, myelofibrosis and serious fibrotic lung and liver diseases."

LOXL2 is expected to play a major role in tumour progression and metastasis as well as in the development of fibrotic diseases.

Currently, simtuzumab is being assessed in several ongoing Phase II trials, including in combination with FOLFIRI for advanced colorectal cancer, in combination with ruxolitinib for myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis, and for liver fibrosis caused by non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).