Celgene's Abraxane: Two Month Survival Boost In Pancreatic Cancer Trial

SUMMIT, NJ ( TheStreet) -- The addition of Celgene's ( CELG) cancer drug Abraxane to the chemotherapy drug gemcitabine prolonged the survival of patients with advanced pancreatic cancer by slightly less than two months over treatment with gemcitabine alone, according to results from a phase III study released Tuesday night.

Patients treated with the Abraxane-gemcitabine regimen reported a median overall survival of 8.5 months compared to 6.7 months for patients treated with gemcitabine. That works out to a survival benefit of 55 days, or a day shy of eight weeks.

Celgene announced the detailed Abraxane results in conjunction with the lifting of an embargo on research abstracts to be presented at an American Society of Clinical Oncology meeting focused on gastro-intestinal cancer research that starts Thursday.

The eight-week survival benefit offered by Abraxane is in line with investor expectations, according to a survey conducted last week by ISI Group analyst Mark Schoenebaum.

Celgene shares closed Tuesday down less than 1% to $99.31 ahead of the Abraxane data announcement. In after-hours trading, the stock fell another 1% to $98.25 Celgene has been the highest-flying large-cap biotech stock this year -- up 27% to date -- due to high expectations for accelerating revenue growth (from Abraxane and other drugs) plus optimism about the company's late-stage drug pipeline.

The Celgene contingent value right ( CELGZ) tied to Abraxane closed Tuesday up 3% to $7.50, an all-time high.

Abraxane sales could reach $1 billion to $1.25 billion by 2015, Celgene forecast at the J.P. Morgan Healthcare Conference on Jan. 7. Abraxane is approved currently for breast cancer but Celgene plans to seek FDA approval for an expanded label in lung cancer and pancreatic cancer. Final Abraxane sales for 2012 have yet to be released but will likely total around $400 million.

Biotech investors, click here to visit TheStreet's 2013 FDA and EMA drug approval decision calendar.

Abraxane is a novel reformulation of the old chemotherapy drug paclitaxel. In this latest study, 861 treatment-naive pancreatic cancer patients were randomized to treatment with Abraxane plus the chemotherapy gemcitabine or gemcitabine alone. Celgene designed the pancreatic cancer study to show an approximate two-month survival advantage for Abraxane plus gemcitabine over gemcitabine alone. Historically, patients treated with gemcitabine alone live about six months.

In addition to the median 8-week survival advantage, Abraxane plus gemcitabine reduced the overall risk of death by 28% compared to gemcitabine alone.

At one year, 35% of Abraxane patients were still alive compared to 22% of patients in the control arm. Abraxane doubled the two-year survival rate but still only 9% of patients were alive at that point, a testament to the difficulty in treating pancreatic cancer.

Median progression-free survival favored Abraxane-gemcitabine over gemcitabine by 55 days (5.5 months vs. 3.7 months.) Twenty-three percent patients responded to Abraxane treatment compared to 7% in the control arm.

The most commonly reported serious toxicities associated with Abraxane were neutropenia (low white blood cell counts), fatigue and neuropathy, or nerve numbness/pain, reported in 17% of Abraxane-treated patients compared to 1% of gemcitabine-treated patients.

Gemcitabine is the current standard of care for pancreatic cancer even with the 2005 approval of Astellas and Roche's ( RHHBY) Tarceva. FDA approved Tarceva in pancreatic cancer based on a study which demonstrated a short, 14-day median survival benefit over gemcitabine.

More recently, a four-drug chemotherapy regimen known as FOLFIRINOX demonstrated a 4.3-month survival benefit over gemcitabine (11.1 months versus 6.8 months) with 48% of pancreatic cancer patients treated with FOLFIRINOX alive at one year. However, the FOLFIRINOX regimen was also found to be very toxic, with 46% of patients reporting serious neutropenia, among other side effects.

Last year, Clovis Oncology ( CLVS) reported disappointing results from a phase III study of its pancreatic cancer drug while Threshold Pharmaceuticals ( THLD) moved its own product into phase III studies.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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