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Pancreatic Cancer Drug Simtuzumab Fails Mid-Stage Study

Monoclonal antibody equivalent to placebo in improving survival

Disappointing results have been reported from a phase II trial of simtuzumab (Gilead Science), 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 with placebo plus gemcitabine. PFS was the study’s primary endpoint. Detailed results will be presented at the European Society for Medical Oncology Congress (ESMO 2014), to be held September 26–30 in Madrid, Spain.

In the randomized, double-blind, placebo-controlled trial, 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab (200 mg [n = 76] or 700 mg [n = 79]) or placebo (n = 81) in 28-day cycles.

The median PFS for the simtuzumab 200 mg, simtuzumab 700 mg, 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. Gemcitabine-related toxicities included anemia, thrombocytopenia, neutropenia, and nausea. There was no difference in adverse events between patients taking simtuzumab or placebo.

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

Simtuzumab is being evaluated in several ongoing phase II trials, including in combination with leucovorin, fluorouracil, and irinotecan (FOLFIRI) for advanced colorectal cancer; in combination with ruxolitinib for myelofibrosis; as monotherapy for idiopathic pulmonary fibrosis; and as monotherapy for hepatic fibrosis caused by non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis.

Source: Gilead Sciences; September 17, 2014.

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