This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Results Of Phase 3 ABRAXANE® Combination Trial In First-Line Non-Small Cell Lung Cancer Show 31 Percent Improvement In Response Rate Compared With Taxol Combination

Abraxis BioScience, Inc. (NASDAQ:ABII) announced today that findings from their phase 3 randomized trial of n anoparticle a lbumin b ound ( 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 46 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (6:30 PM EDT E Hall D2).

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. 1,2,3 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/m 2) weekly or solvent-based paclitaxel (200 mg/m 2) 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.”

1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
AAPL $121.30 0.00%
FB $94.01 0.00%
GOOG $625.61 0.00%
TSLA $266.15 0.00%
YHOO $36.67 0.00%

Markets

Chart of I:DJI
DOW 17,689.86 -56.12 -0.32%
S&P 500 2,103.84 -4.79 -0.23%
NASDAQ 5,128.2810 -0.5040 -0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs