WAYNE, N.J., SOUTH SAN FRANCISCO, Calif. and TOKYO, July 23, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX), and Astellas Pharma Inc. (TSE: 4503) today announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva ® (erlotinib) tablets to Nexavar ® (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone. The SEARCH ( S orafenib and E rlotinib, a r A ndomized t R ial proto C ol for the treatment of patients with H epatocellular carcinoma) trial compared Nexavar in combination with Tarceva to Nexavar alone. The safety and tolerability of the treatment combination were generally as expected based upon experience and use of the two products alone and there were no new or unexpected toxicities or changes to the respective product safety profiles observed. Data from this study will be presented at an upcoming scientific meeting. Nexavar is jointly developed by Bayer and Onyx. Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Group.
"The data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with unresectable HCC," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "The results of this trial confirm the efficacy and safety profile of Nexavar in the treatment of unresectable liver cancer."
About the Phase 3 Study
The SEARCH trial was an international multicenter placebo-controlled Phase 3 study that randomized 720 patients with advanced liver cancer. The study examined whether the addition of Tarceva to Nexavar prolongs survival as compared to Nexavar alone in patients with unresectable HCC. The primary endpoint of the study was overall survival (OS) and the secondary endpoints were safety, time to radiographic progression (TTP), disease control rate (DCR) and patient-reported outcome. Patients were randomized to receive either 400 mg of Nexavar twice daily and 150 mg of Tarceva once daily or 400 mg of Nexavar twice daily with matching placebo.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV