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

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 - Get Report) 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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