September 17, 2014
Gilead Announces Data From Phase 2 Study of Simtuzumab for Previously Untreated Pancreatic Cancer
-- Data to be Presented at
In this randomized, double-blind, placebo-controlled Phase 2 trial, 236 patients with advanced pancreatic cancer received intravenous gemcitabine plus either intravenous simtuzumab (200 mg, n=76; 700 mg, n=79) or placebo (n=81) in cycles of 28 days. 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. Expected gemcitabine-related toxicities included anemia, thrombocytopenia, neutropenia and nausea. There was no difference in adverse events between patients taking simtuzumab versus placebo.
“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
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 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).
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.
Additional information about clinical studies of simtuzumab and Gilead’s other investigational cancer agents can be found at www.clinicaltrials.gov. Simtuzumab, momelotinib and GS-5745 are investigational products and their safety and efficacy have not been established.
About Gilead Sciences
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from clinical trials involving
simtuzumab in other therapeutic areas. Gilead may also experience
challenges in enrolling patients in clinical studies, requiring those
studies to be modified or delayed. Further, Gilead may make a strategic
decision to discontinue development of simtuzumab if, for example,
Gilead believes commercialization will be difficult relative to other
opportunities in its pipeline. As a result, simtuzumab may never be
successfully commercialized. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Nathan Kaiser, 650-522-1853