Abraxis BioScience, Inc. Release: Results of Phase 3 ABRAXANE(R) Combination Trial In First-Line Non-Small Cell Lung Cancer Show 31 Percent Improvement In Response Rate Compared With Taxol Combination

LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABII) announced today that findings from their phase 3 randomized trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) plus carboplatin, showed a statistically significant 31 percent improvement in overall response rate (ORR) when compared with Taxol® (paclitaxel) injection plus carboplatin in the first-line treatment of patients with non-small cell lung cancer (NSCLC). Patients in the ABRAXANE arm demonstrated an ORR of 33 percent compared with those receiving Taxol, with an ORR of 25 percent, as assessed by independent radiologic review using RECIST criteria. This difference met statistical significance at p=0.005 and achieved the primary end point agreed to with the FDA in a Special Protocol Assessment. In addition, analysis of the highly difficult-to-treat subset of squamous cell carcinoma, showed a 67 percent improvement (p<0.001) in those who received the ABRAXANE combination versus those who received the Taxol combination. Results from this randomized registrational trial (Abstract # LBA7511) will be presented for the first time as a late-breaker during an oral session on June 7 at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (6:30 PM EDT E Hall D2).

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