Gilead Sciences, Inc. has announced results from their phase 2 trial studying simtuzumab plus gemcitabine for the treatment of patients with previously untreated advanced pancreatic cancer. Researchers found that patients who received gemcitabine in combination with simtuzumab 200 mg or 700 mg did not have a significantly increased progression-free survival (PFS) compared with those who received gemcitabine plus placebo.
In the randomized, double-blind, placebo-controlled study, researchers administered gemcitabine plus simtuzumab 200 mg to 76 patients, simtuzumab 700 mg to 79 patients, or placebo to 81 patients. PFS was found to be 3.5 months, 3.7 months, and 3.7 months, respectively. Researchers observed expected toxicities associated with gemcitabine, including anemia, nausea, neutropenia, and thrombocytopenia. There were no adverse effects found to be associated with simtuzumab versus placebo.
Simtuzumab is an investigational lysyl oxidase-like-2 (LOXL2) inhibitor and monoclonal antibody. LOXL2 is believed to have a significant role in cancer growth and spread, as well as in the development of fibrotic diseases like idiopathic pulmonary fibrosis and myelofibrosis. Simtuzumab is currently being studied in numerous phase 2 trials for both cancer and fibrotic diseases.
Gilead Sciences, Inc. will be presenting detailed results of the study at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain, this week.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase 2 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 (200 mg or 700 mg) 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 (Abstract #5072).