Abraxane extends life of pancreatic cancer patients

Patients taking Abraxane with the chemotherapy gemcitabine survived a median of 8.5 months, compared with 6.7 months for those only on the single drug, Summit, N.J.-based Celgene said Tuesday in a statement. Based on the results, the company said it plans to file in the first half of the year for approval in the United States and Europe.

Pancreatic cancer killed an estimated 37,390 people in the U.S. last year, according to the National Cancer Institute. The disease spreads quickly and usually isn't detected until it has advanced, making it a leading cause of cancer deaths, the Mayo Clinic says. Abraxane may generate $2.1 billion in peak global sales for use in pancreatic cancer, Eric Schmidt, an analyst with Cowen & Co., estimated.

"The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is both deadly and incredibly difficult to treat with success," Daniel Von Hoff, lead investigator of the trial and chief scientific officer for Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials, said in a statement. "The fact that Abraxane plus gemcitabine demonstrated an overall survival benefit, and also did so at one and two years, is a significant step forward in offering potential new hope for our patients."

The 861-person study, from the third and final phase of clinical trials generally required for U.S. regulatory approval, showed that Abraxane helped more patients survive to one year, at 35 percent versus 22 percent in the gemcitabine-alone group. Nine percent of patients taking Abraxane survived to two years, compared with 4 percent receiving only gemcitabine.

Abraxane is a form of the chemotherapy paclitaxel that's formulated with the human protein albumin to help deliver a strong dose directly to the tumor. Celgene acquired the drug in its 2010 purchase of Abraxis BioScience for $2.9 billion. It is approved to treat breast cancer and non-small cell lung cancer and generated sales of about $386 million in 2011.

The drug was related to a higher incidence of neutropenia, or low white blood cell count, at 38 percent compared with 27 percent. More patients also experienced fatigue, at 17 percent versus 7 percent, and neuropathy, or nerve damage, at 17 percent versus 1 percent. Gemcitabine is sold by Eli Lilly & Co. as Gemzar.

Analysts had been expecting a benefit in survival of at least two months, Michael Yee, of RBC Capital Markets, wrote in a Jan. 21 research note. Yee, who recommends buying Celgene shares, also said he was looking to see safety and tolerability in the Abraxane and gemcitabine regimen, noting another combination therapy, folfirinox, has much higher toxicity than gemcitabine, limiting its use despite an improvement in survival. The treatment combines chemotherapy drugs leucovorin, fluorouracil, irinotecan and oxaliplatin.

The data will be presented later this week at the American Society of Clinical Oncology's 2013 Gastrointestinal Cancers Symposium in San Francisco.