Gilead's simtuzumab fails in Ph II pancreatic cancer study

US biotech major Gilead Sciences (Nasdaq: GILD) has announced disappointing results from a Phase II study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer.

In the study, the addition of simtuzumab (200mg or 700mg) to gemcitabine did not significantly increase progression-free survival (PFS) compared to placebo plus gemcitabine. PFS was the primary endpoint of the study. Detailed results will be presented during a poster session at the European Society for Medical Oncology Congress (ESMO 2014) in Madrid, Spain, September 26-30.

In this randomized, double-blind, placebo-controlled Phase II trial, 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab (200mg, n=76; 700mg, n=79) or placebo (n=81) in cycles of 28 days. Median PFS for the simtuzumab 200mg, simtuzumab 700mg and placebo groups was 3.5 months, 3.7 months and 3.7 months, respectively. The difference in PFS between the simtuzumab and placebo arms was not statistically significant. Expected gemcitabine-related toxicities included anemia, thrombocytopenia, neutropenia and nausea. There was no difference in adverse events between patients taking simtuzumab versus placebo.