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

Synta Announces Positive One-Year Follow-up Results For The GALAXY-1 Trial Of Ganetespib In NSCLC At The 2013 World Conference On Lung Cancer

Summary of key GALAXY-1 one-year follow-up findings being presented at the WCLC Meeting

A detailed presentation of the one-year follow-up analysis results may be found on the home page of the Company’s website, www.syntapharma.com. Key findings include:

  • 65% of overall survival (OS) events in the primary adenocarcinoma population have occurred.

    • Targeting at least 70% of OS events for final analysis, expected by early 2014.
  • Consistent with previously reported results, encouraging OS improvements were observed in the prespecified chemosensitive patient population (diagnosis of advanced disease greater than 6 months; N=178), together with a lack of activity in the refractory population. These results continue to confirm the selection of the chemosensitive patient population for the GALAXY-2 Phase 3 trial.

    • Overall survival Hazard Ratio in the chemosensitive population was 0.75 (90% CI 0.56, 1.03; 1-sided p=0.065) and 0.72 (90% C.I. 0.52, 0.98; 1-sided p=0.040) in the Cox proportional hazards univariate (unadjusted) and multivariate (adjusted) models, respectively. Median overall survival was 10.7 months for ganetespib and docetaxel versus 7.4 months for docetaxel alone.
  • The trial evaluates two other potential biomarkers for use in selecting patients for the Phase 3 trial, elevated LDH (eLDH) and mutant KRAS (mKRAS). The eLDH population continued to show promising PFS and OS improvements, consistent with the hypothesis of HIF-1alpha inhibition by ganetespib, and LDH as a marker for upregulated HIF-1alpha. No evidence for enhanced activity in the mKRAS population was observed.
  • Certain differences in enrollment and treatment patterns across centers, which can confound large, global studies, were observed in GALAXY-1. These observations have allowed for further optimization of the GALAXY-2 Phase 3 trial.

“We are encouraged by these results and the implications for Phase 3,” said Dr. Vojo Vukovic, Chief Medical Officer, Synta. “In addition to confirmation of the choice of patient selection, the results give us useful information for optimizing the GALAXY-2 operational plan and statistical assumptions.”

2 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
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,960.76 -109.64 -0.61%
S&P 500 2,094.70 -19.79 -0.94%
NASDAQ 4,944.2040 -72.7250 -1.45%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs