This Day On The Street
Continue to site right-arrow
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

AVEO Announces Detailed Results Of Exploratory Phase 2 Study Evaluating Ficlatuzumab In First-Line Patients With Advanced Non-small Cell Lung Cancer; New Data Presented At ESMO

AVEO Oncology (NASDAQ: AVEO) today announced that detailed results from an exploratory, randomized Phase 2 study evaluating the combination of ficlatuzumab, the company’s HGF inhibitory antibody, and gefitinib compared to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung cancer (NSCLC) were presented at the 2012 Congress of the European Society for Medical Oncology (ESMO). As previously reported, the study did not achieve its primary endpoint; however, the results presented at ESMO suggest that the addition of ficlatuzumab to gefitinib may be effective in select subsets of patients.

“The insights gleaned from the Phase 2 study, along with new pharmacodynamic data, show that inhibiting the HGF ligand may be important in the treatment of cancer,” stated Tuan Ha-Ngoc, president and chief executive officer, AVEO. “We, along with our scientific advisors and clinical investigators, remain encouraged about ficlatuzumab and believe the program warrants further evaluation. Our top priority is the registration and commercialization of tivozanib, and with that in mind, we will be focusing our efforts on further ficlatuzumab development through external collaborations, including with academic institutions and cooperative groups.”

“This study has identified potential predictive biomarkers for the use of ficlatuzumab in patients with advanced NSCLC,” said Tony Mok, M.D., professor, Department of Clinical Oncology, The Chinese University of Hong Kong, and senior investigator of the study. “Based on these results, ficlatuzumab merits additional clinical investigation.”

The primary endpoint of the study was overall response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS) and correlation of biomarkers with clinical activity. In the intent to treat (ITT) population, the addition of ficlatuzumab to gefitinib did not result in statistically significant improved ORR or PFS in Asian treatment-naïve NSCLC patients. The preliminary OS hazard ratio in the ITT population for ficlatuzumab plus gefitinib versus gefitinib monotherapy was 0.84 (95% CI 0.52, 1.37). Final OS data will be presented once they are mature. The combination was well-tolerated, with no clinically meaningful differences in adverse event rates observed between the two arms.

1 of 4

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!


DOW 17,698.18 -77.94 -0.44%
S&P 500 2,059.69 -8.20 -0.40%
NASDAQ 4,880.2280 -20.6570 -0.42%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs