Gilead's oncology contender comes up short in pancreatic cancer

Gilead Sciences' ($GILD) simtuzumab failed to meet its main goal in a Phase II pancreatic cancer trial, denting the potential of a therapy the company hopes can treat a wide range of malignancies.

Simtuzumab is an antibody that blocks the LOXL2 enzyme, which is believed to play a major role in tumor progression and fibrosis. To test its mettle in pancreatic cancer, Gilead enrolled 236 treatment-naive patients, dosing half with a combination of simtuzumab and chemotherapy and the rest with standard treatment alone. After 28 weeks, simtuzumab proved no better than placebo at forestalling tumor progression, Gilead said, flunking its primary endpoint.

But that hardly spells the end for simtuzumab, as the pancreatic study was just one of 5 ongoing Phase II trials on the drug, the company said.

Gilead CSO Norbert Bischofberger

"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," Chief Scientific Officer Norbert Bischofberger said in a statement.

And analysts say those last two indications may be the drug's best bets.

On the lung disease side, Gilead is studying simtuzumab in idiopathic pulmonary fibrosis (IPF), a rare ailment with no approved treatments and potential market that helped convince Roche ($RHHBY) to pay $8.3 billion for InterMune ($ITMN). And the drug's targeted indication in liver disease is fibosis caused by non-alcoholic steatohepatitis (NASH), another unmet medical need that has jump-started the shares of Intercept Pharmaceuticals' ($ICPT), a leader in the space.

Still, the Phase II misstep is a blow for Gilead's on-the-come-up cancer department, which has largely been pieced together through M&A over the past three years. Idelalisib, a blood cancer treatment approved in July as Zydelig, came through the company's $600 million deal for Calistoga Pharmaceuticals in 2011, while momelotinib, a Phase III myelofibrosis drug, was the target of Gilead's $510 million buyout of YM Biosciences a year later. Rounding out the oncology pipeline is GS-9973, which targets blood malignancies, and GS-5745, designed to combat solid tumors.

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