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

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

Safety

Across both Group 1 and Group 2, rindopepimut plus bevacizumab was very well tolerated (dosing up to 13+ months). There were no unexpected toxicities associated with concomitant bevacizumab administration and there were no treatment-related toxicities resulting in discontinuation of study treatment. Adverse events were consistent with prior studies of rindopepimut.

Phase 2 Frontline Long-term Overall Survival Assessments (ACT III, ACT II and ACTIVATE)

Celldex also announced today the presentation of four- and five-year survival data from the Phase 2 rindopepimut clinical program (3 studies; pooled n=105) in EGFRvIII-positive glioblastoma. Across three Phase 2 studies of rindopepimut, survival data remains consistent and suggests a substantial and continuing survival benefit in comparison to independent control datasets (see chart below) at the median and at all other time points evaluated. 

Phase 2 Frontline Long-term Overall Survival Assessments (ACT III, ACT II and ACTIVATE)
  Median, Years (95% CI) 2-year rate 3-year rate 4-year rate 5-year rate
Phase 2 Rindopepimut Studies, Pooled (n=105) 2.1 (1.8, 2.4) 51% 30% 18% 14%
Matched historical control (n=17)* 1.3 (0.9, 1.7) 6% 6% 0% 0%
*Patients treated at M.D. Anderson contemporaneously to ACTIVATE, matched for major eligibility requirements, including EGFRvIII+ GBM, GTR and no PD through CRT.

The pooled overall long-term survival results continue to be consistent with the ACT III Phase 2 study (18% for 4-years and 14% for 5-years). The Phase 3 registration study, ACT IV, is modeled after the ACT III study.

6 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
Only $9.95
14-Days Free
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 18,073.60 -6.54 -0.04%
S&P 500 2,118.33 +0.64 0.03%
NASDAQ 5,084.9490 -7.1360 -0.14%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs