This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Phase 3 DECISION Trial Of NEXAVAR (sorafenib) In Locally Recurrent Or Metastatic, Progressive, Differentiated Thyroid Cancer Refractory To Radioactive Iodine Published In The Lancet

Stocks in this article: AMGN

WHIPPANY, N.J. and THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., April 23, 2014 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that The Lancet published online results from the Phase 3 DECISION trial which demonstrated that NEXAVAR ® (sorafenib) tablets significantly extended the time patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment lived without their disease worsening (progression-free survival; PFS). 

Based on these data, NEXAVAR was approved by the U.S. Food and Drug Administration (FDA) in November 2013 for patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. These patients previously had limited approved treatment options.

"The Lancet publication will give healthcare providers greater insight into the DECISION trial. While the majority of differentiated thyroid cancers are treatable, patients who are no longer responding to standard therapies - including surgery and radioactive iodine - are more difficult to treat and have limited options," said Marcia Brose, M.D., Ph.D., principal investigator of the DECISION trial and Assistant Professor in the Department of Otorhinolaryngology: Head and Neck Surgery in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania. "The DECISION trial demonstrates the activity of sorafenib for this type of differentiated thyroid cancer in patients with this challenging tumor."   

About the DECISION Trial The DECISION (stu Dy of soraf Enib in lo Cally advanced or metastat Ic patient S with radioactive Iodine refractory thyr Oid ca Ncer) trial was an international, multicenter, placebo-controlled study that evaluated 417 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine treatment.  The primary endpoint of the study was progression-free survival (PFS), or the length of time patients lived without their thyroid cancer worsening, and was evaluated by an independent radiological review using modified Response Evaluation Criteria in Solid Tumors (mRECIST). Secondary endpoints included overall survival (OS), tumor response rate, and duration of response. Safety and tolerability were also evaluated.  

Results were presented in a plenary session at the American Society of Clinical Oncology Annual Meeting in June 2013.

Median PFS was 10.8 months (95% CI 9.1-12.9) among patients treated with NEXAVAR, compared to 5.8 months (95% CI 5.3-7.8) among patients receiving placebo (HR=0.59 [95% CI, 0.46, 0.76]; p<0.001).  There was no statistically significant difference in overall survival (HR= 0.80 [95% CI, 0.54–1.19]; p=0.14), a secondary endpoint of the trial.  Following investigator-determined disease progression, 157 (75%) patients randomized to placebo crossed over to open-label NEXAVAR, and 61 (30%) patients randomized to NEXAVAR received open-label NEXAVAR.

1 of 7

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,356.87 +288.00 1.69%
S&P 500 2,012.89 +40.15 2.04%
NASDAQ 4,644.3120 +96.4780 2.12%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs