Gilead Sciences, Inc.'s Experimental Drug Simtuzumab Fails Mid-Stage Study
September 17, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Biopharmaceutical company Gilead Sciences, Inc. (GILD) said Wednesday that its Phase II study evaluating pancreatic drug simtuzumab in combination with gemcitabine did not significantly increase progression-free survival (PFS) but said it would continue testing the drug’s efficacy treating cancer and fibrotic diseases.
The Foster City, Calif.-based company had been comparing success rates to placebo plus gemcitabine in patients with previously untreated advanced pancreatic cancer.
The double-blind Phase II trial consisted of 236 patients with advanced pancreatic cancer, who received intravenous gemcitabine plus either 200 mg intravenous of simtuzumab, 700 mg of simtuzumab or a placebo in cycles of 28 days.
The endpoint of the study was progression-free survival, which did not differ in a statistically significant way among the three groups. The addition of simtuzumab to gemcitabine did not cause any more adverse reactions in patients compared to the addition of placebo to gemcitabine.
“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, Gilead’s executive vice president of research and development and chief scientific officer.
Simtuzumab is an inhibitor of lysyl oxidase-like-2 (LOXL2), which is thought to play an important role in tumor progression and metastasis and in the development of fibrotic diseases. The drug is still being tested in Phase II trials for patients with idiopathic pulmonary fibrosis, a rare lung disease, and for liver fibrosis caused by non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In addition, a treatment that combines simtuzumab and FOLFIRI, a chemotherapy regimen, is being evaluated for patients with advanced colorectal cancer, as is a treatment that combines simtuzumab with ruxolitinib, a Janus kinase (JAK) inhibitor, for patients with myelofibrosis.
Pancreatic cancer, one of the most lethal forms of cancer, has caused 39,590 deaths thus far in 2014, according to the National Cancer Institute. Even with early detection, pancreatic cancer has a poor prognosis. Often, symptoms do not arrive until the cancer has progressed past the point of a possible surgical treatment.
Gilead has not given up on finding an effective non-surgical treatment for pancreatic cancer, however. Other agents in Gilead’s oncology pipeline, including momelotinib and GS-5745, are currently being evaluated in clinical trials for treatment of the disease.
Detailed results of the simtuzumab plus gemcitabine Phase II trial will be presented during a poster session at the European Society for Medical Oncology Congress in Madrid, Spain, Sept. 26-30.