Paclitaxel protein-bound (Abraxane) looks to be the cancer drug that keeps on giving to Celgene (NYSE: CELG). The Summit, NJ-based company reported late in the day on Tuesday that a pivotal clinical trial of the drug combined with chemotherapy kept patients with advanced pancreatic cancer alive some two months longer than those on chemotherapy alone. As a result, Celgene said it will seek Food & Drug Administration approval for the drug against pancreatic cancer in the first half of this year.
Celgene acquired paclitaxel protein-bound when it bought Abraxis Bioscience for $2.9 billion in 2010. The drug had already been approved to treat breast cancer in 2005 and last October the FDA approved the drug for non-small-cell lung cancer. At the JP Morgan conference in San Francisco earlier this month, Celgene CEO Bob Hugin forecast that Abraxane annual sales will reach $1 billion to $1.25 billion by 2015 and $1.5 billion to $2 billion in 2017.
Pancreatic cancer is extremely difficult to treat; by the time it is detected the fast-moving cancer has usually spread, and patients die within months. Consequently, although only 2.1 percent of all U.S. cancer cases each year are pancreatic cancer, it is the fourth leading cause of cancer death, killing 38,000 people a year.
The Celgene drug is a form of the widely used chemotherapy drug paclitaxel (Taxol), combined with tiny particles of the human protein albumin that are meant to increase the amount of the drug that is delivered directly to the tumor. The trial results, which will be presented in full on Friday at the American Society of Clinical Oncology’s Gastrointestinal Cancers annual meeting in San Francisco, revealed that patients on paclitaxel protein-bound survived a median of 8.5 months compared with 6.7 months for those receiving standard chemotherapy treatment.
In addition, at the end of one year 35 percent of trial participants on the Celgene drug were still alive, compared with 22 percent of those on chemotherapy alone. There were 861 patients in the study. After two years the survival figures were 9 percent and 4 percent respectively—indicative of how dire a diagnosis pancreatic cancer is.
“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 the Celgene press release. “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.”
Abraxane may have trouble breaking through in the market if it is approved for pancreatic cancer, however. An older treatment called Folfirinox, a combination of four generic chemotherapy drugs, performed even better against the disease in a clinical trial published in 2011. In that trial, the patients on Folfirinox had a median survival rate of 11.1 months, almost three months longer than with the Celgene drug. However, the Celgene drug can be easier to administer and have fewer side effects.