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>th/sup> Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (6:30 PM EDT E Hall D2).
“This is an important finding as we continue to look for new treatment options for lung cancer patients, especially those in late stage.”
Typical first-line chemotherapy treatment used in patients with NSCLC is paclitaxel in combination with platinum. Platinum-based doublet therapy in NSCLC has reached a therapeutic plateau, producing a 15-25 percent ORR, regardless of the combination used. The activity of ABRAXANE, with a 33 percent ORR, is postulated to be as a result of targeting an albumin-specific receptor (gp60), thereby activating a process known as transcytosis to create a path through the proliferating blood vessel wall allowing the administered drugs to reach the tumor cells in higher concentration. This hypothesis is the subject of ongoing pre-clinical and clinical research.
In this phase 3 study, 1,052 patients with histologically or cytologically confirmed stage IIIB or IV NSCLC who had not received prior treatment for metastatic disease were randomized 1:1 to receive six cycles of carboplatin AUC 6 on day one of a three-week treatment cycle in combination with either nab-paclitaxel (100 mg/m2) weekly or solvent-based paclitaxel (200 mg/m2) every three weeks until disease progression or unacceptable toxicity.
"The results of this phase 3 study confirmed that the nab-paclitaxel and carboplatin combination demonstrated a response to treatment that is superior to a current standard of care in advanced non-small cell lung cancer," said Mark Socinski, M.D., principal investigator, University of North Carolina Lineberger Comprehensive Cancer Center. "This is an important finding as we continue to look for new treatment options for lung cancer patients, especially those in late stage."
"These lung cancer trial results support the efficacy of ABRAXANE in advanced and difficult-to-treat cancers," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "Of particular interest to us, ABRAXANE was highly active in the squamous cell subset, which may be related to the aberrant caveolin-1 over-expression in squamous cell carcinoma. We are extremely pleased by the results of this trial, and look forward to continued advancements in the treatment of this devastating disease."
This trial is the subject of a Special Protocol Assessment with the FDA, which means that the agency has previously agreed to study design, clinical endpoints and statistical analyses. Specifically, the FDA has stipulated that demonstrating statistically superior response rate of the nab-paclitaxel and carboplatin combination over the paclitaxel and carboplatin combination with an acceptable safety profile would be sufficient to submit a supplemental new drug application (sNDA) (as a 505(b)(2) submission) for approval of nab-paclitaxel in combination with carboplatin for the first-line treatment of NSCLC.
Difficult-to-treat, NSCLC accounts for approximately 85 percent 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.