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
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.
reported disappointing results from a phase III study of its pancreatic cancer drug while
(THLD - Get Report)
moved its own product into phase III studies.
-- Reported by Adam Feuerstein in Boston.