Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Mar 17 2010

Abraxis BioScience, Inc. (NASDAQ:ABII) today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE^® (protein-bound paclitaxel) with Taxol^® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

“This is exciting news for lung cancer patients and has important implications not only in late stage cancer but also in earlier stages of the disease”

The Phase 3 trial completed enrollment of 1,052 patients in July 2009 at 102 sites globally and was led by principal investigator Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to be conducted. “This is exciting news for lung cancer patients and has important implications not only in late stage cancer but also in earlier stages of the disease,” Socinski said. The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting.

This trial is the subject of a special protocol assessment (SPA) with the FDA, which means that the design, clinical endpoints and statistical analyses of the trial have been previously agreed upon by the FDA. Specifically, the FDA agreed that the demonstration of a statistically superior response rate of the ABRAXANE and carboplatin combination over the Taxol and carboplatin combination would be sufficient to submit a supplemental new drug application (sNDA)(as a 505(b)(2) submission) for approval of ABRAXANE in combination with carboplatin for first line NSCLC.

“NSCLC is the most common form of lung cancer and is very difficult to treat. We are extremely pleased with the data from this Phase 3 combination study that demonstrated superiority of ABRAXANE over Taxol as we seek to bring new treatment options to these patients,” said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. “We anticipate filing an sNDA to the FDA during 2011 for what will be the second indication for ABRAXANE in the U.S.”

NSCLC accounts for approximately 85% of all lung cancer cases. The American Cancer Society (ACS) estimates that approximately 219,440 people will be diagnosed with lung cancer in the United States in 2009, and that approximately 159,000 deaths occur each year due to this cancer.