Gilead drug fails in pancreatic cancer

A novel cancer treatment from Gilead has failed in phase 2 trials in advanced pancreatic cancer.

The drug simtuzumab, is an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), and was being studied in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. The trial showed that adding simtuzumab (200 mg or 700 mg) to gemcitabine did not significantly increase progression-free survival (PFS) (the primary endpoint) compared to placebo plus gemcitabine.

The company will present detailed results of the trial at the forthcoming European Society for Medical Oncology Congress (ESMO 2014) in Madrid, but the news is a setback for the company's ambitions to expand into the cancer field.

The firm says it will continue to develop the drug in a number of other cancer indications.

"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," said Norbert Bischofberger, PhD, Gilead's executive vice president of Research and Development and Chief Scientific Officer.

Simtuzumab is a monoclonal antibody that is highly selective for LOXL2, an enzyme that modifies the extracellular matrix by promoting the cross-linking of collagen fibres. LOXL2 is thought to play an important role in tumour progression and metastasis and in the development of fibrotic diseases.

Simtuzumab is being evaluated in several ongoing phase 2 trials, including in combination with FOLFIRI for advanced colorectal cancer, in combination with ruxolitinib for myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis, a rare lung disease, and for liver fibrosis caused by non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

The two indications have generated interest after drugs in the pipeline from Intercept and InterMune produced promising results.

Other agents in Gilead's oncology pipeline, including momelotinib and GS-5745, are currently being evaluated in clinical trials for the treatment of pancreatic cancer.

Gilead acquired rights to simtuzumab when it bought privately held biotech Arresto Therapeutics in December 2010.