By Joseph Walker
Celgene Corp. (>> Celgene Corporation) said a late-stage trial of its drug Abraxane extended survival by nearly two months in pancreatic cancer patients, offering a potentially significant lifespan advancement for patients suffering from one of the deadliest and least-understood tumors.
Celgene will apply for approval with the Food and Drug Administration in the first half of 2013, and the drug could be approved by the end of this year.
If the combination therapy is approved, it could become the standard of care for the majority of patients suffering from pancreatic cancer, and eventually generate $1 billion to $2 billion annually for Celgene, according to some analysts.
The late-stage trial data, to be presented at a medical meeting Friday, comes as Celgene embarks on an ambitious long-term strategic plan to expand beyond its core blood cancer franchise. The company has said it expects Abraxane for pancreatic cancer to be one of the cornerstones of its product strategy and to help double revenue by 2017.
Growing investor optimism about Celgene has helped the company's stock rise nearly 27% since the beginning of the year.
The phase-three trial showed that patients receiving Abraxane in combination with gemcitabine, a generic chemotherapy that is the current standard of care, had a median survival rate of 8.5 months, compared with 6.7 months for patients taking gemcitabine alone.
The increased survival benefit of 1.8 months was just shy of the two-month benefit analysts had been expecting after Celgene said in November that the trial had met its primary goal.
"Many of us on Wall Street are ready to become big fans of Abraxane once we see the detailed results" of the pancreatic cancer trial, Eric Schmidt, a Cowen and Co. analyst, said before the results.
Nonetheless, while the less-than-two-month extension of life would not seem extraordinary in most cancers, it could represent a significant advancement in the field of pancreatic cancer research. A number of drug companies, including Amgen Inc. (>> Amgen, Inc.) and most recently Clovis Oncology Inc. (>> Arbinet Corporation), have tried and failed to increase survival by more than a couple of weeks.
Pancreatic cancer is one of the most difficult cancers to treat, as it is rarely detected before it has spread throughout the body. Even for patients diagnosed before their tumors metastasize, the five-year survival rate is just 22%, according to the American Cancer Society.
Some 35% of trial patients survived at least a year taking the Abraxane combination, compared with 22% of those in the gemcitabine-only group. The average one-year survival rate among all pancreatic cancer patients is 26%, according to the ACS.
Among serious side effects, the most common were neutropenia, which can make patients susceptible to infection, fatigue and the nerve damage condition known neuropathy.
Among the trial's secondary goals, patients receiving the combination therapy experienced 5.5 months without their cancers progressing, compared with 3.7 months in the control arm.
An increase in research funding in recent years has led to advancements in understanding the disease, said Daniel Alexander Laheru, an associate professor of oncology and co-director of the Skip Viragh Center for Pancreas Cancer at John Hopkins University.
In 2011, French researchers found that a cocktail of several generic drugs increased survival by 63% to 11 months in pancreatic cancer patients. The cocktail, known as Folfirinox, however, also causes serious side effects and is estimated to make up about 10% of the market, according to Cowen's Mr. Schmidt.
Threshold Pharmaceuticals Inc. (>> Threshold Pharmaceuticals, Inc.) also has an experimental pancreatic cancer drug that it hopes will show a significant survival advancement in a late-stage study.
The advancements made by Folfirinox and now Abraxane are likely to inspire further research into the disease and create bigger advancements in survival, said Dr. Laheru, who was an investigator in the Celgene trial.
"Success breeds success," he said in a recent interview. "Oncologists now have two really good choices for patients."
Celgene shares, which closed at $99.31 Tuesday, have risen sharply so far this year, largely on the strength of its pipeline. The company said it believes it has three "potential blockbuster" drugs in its late-stage pipeline, including Abraxane and apremilast, an experimental therapy to treat the severe skin-condition psoriasis.
Write to Joseph Walker at Joseph.Walker@dowjones.com
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