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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Celldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity In Patients With EGFRvIII-positive Recurrent Glioblastoma At SNO

"Expectations for a vaccine to be active in this patient population were very low," said Thomas Davis, M.D., Senior Vice President and Chief Medical Officer of Celldex. "If these multiple signals for immunologic and anti-tumor activity persist in the final data, it may establish a new perspective on the potential for immunotherapy. These early results have led to the expansion cohort and we are beginning to plan additional studies of combinations that could further improve efficacy."

ReACT is a Phase 2 exploratory study designed to determine if adding rindopepimut to standard of care bevacizumab improves the outcomes for patients with EGFRvIII-positive recurrent glioblastoma across multiple measures. As originally designed, the study included 2 groups:

  • Group 1 - bevacizumab naive, n= apx. 70, enrollment ongoing—patients randomized to receive either rindopepimut or KLH (administered as a control), each along with bevacizumab  
  • Group 2 - bevacizumab refractory, n= apx. 25, enrollment completed—patients receive rindopepimut plus bevacizumab in a single treatment arm

In August 2013, Celldex announced that enrollment had been completed in Group 2 and that, based on early evidence of anti-tumor activity, an expansion cohort of approximately 75 patients (Group 2C) would be added to better characterize the potential activity of rindopepimut in this refractory patient population. As amended, the ReACT study will enroll approximately 170 patients.

Clinical Activity Overview   

Group 1- Recurrent GBM; bevacizumab naive

Interim results are available for the first 40 patients enrolled [rindopepimut + bevacizumab (n=20); control + bevacizumab n=20)]. 12 patients continue to receive treatment and 27 continue to be followed for survival. While the data continue to mature, trends toward both an overall survival (OS) and progression-free survival (PFS) benefit have been observed on the rindopepimut arm to date. 

Interim ReACT Overall Survival and Progression-free Survival Bevacizumab-Naïve Recurrent GBM
  Rindo + Bev (n=20) Control + Bev (n=20)  
OS 12.0 months 7.9 months HR = .43 (0.13, 1.44) ; p=0.16
PFS 3.7 months 2.0 months HR= .74 (0.34, 1.61); p=0.47

The study suggests that early development of high anti-EGFRvIII titer may be predictive of improved outcomes in this patient population, as improved survival was associated with rapid generation of a robust humoral response. All 8 patients on the rindopepimut arm that developed high titers by day 57 are still alive to date (range of 3.6+ to 17.0+ months). For the remaining 10 patients who did not develop high titers by day 57, 5 remain alive (range of 3.8+ to 12.9+ months). Consistent with the premise that EGFRvIII-positive patients fare worse than the general glioblastoma population, results to date suggest that the EGFRvIII-positive patient population had a lower OS in the Control + Bevacizumab arm than was observed in the bevacizumab registration study (AVF3708g) in recurrent glioblastoma in all-comers (7.9 months OS, ReACT vs 9.3 months OS AVF3708g).

2 of 8

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG

Markets

DOW 18,132.70 -81.72 -0.45%
S&P 500 2,104.50 -6.24 -0.30%
NASDAQ 4,963.5270 -24.3630 -0.49%

Partners Compare Online Brokers

Free Reports

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