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!

Clovis Oncology’s CO-1686 Continues To Demonstrate Promising Clinical Activity And Safety In Updated Phase I Study Results

Stocks in this article: CLVS

Clovis Oncology (NASDAQ:CLVS) announced today updated findings from the Phase I portion of its ongoing Phase I/II clinical study of CO-1686, the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. Interim results from the Phase I dose-escalation portion of this Phase I/II study are being presented today in an oral presentation by Professor Jean-Charles Soria at the IASLC 15 th World Conference on Lung Cancer in Sydney.

Six RECIST partial responses have been observed to date in nine evaluable T790M positive patients dosed at 900mg BID of the free base formulation, for a 67 percent objective response rate. Eight of the nine evaluable patients, or 89 percent, experienced tumor shrinkage greater than 10 percent. Fifty-six patients have been treated with CO-1686 to date across all dosing cohorts, with no evidence of systemic wild-type EGFR-driven toxicities such as rash. Dose escalation is ongoing with the improved HBr formulation, currently dosing at 750mg BID, as the maximum tolerated dose (MTD) has not yet been reached.

“These results are exciting, and confirm and extend the initial data reported at ASCO 2013 for this new agent,” said Professor Jean-Charles Soria, Professor of Medicine and Medical Oncology at Paris University XI and cancer specialist at Gustave Roussy Institute. “The T790M acquired resistance mutation is a critical problem in mutant-EGFR lung cancer patients, and CO-1686 appears to be meaningfully benefiting these patients, without triggering the skin and GI toxicities typically seen with older EGFR inhibitors that are not mutant-selective.”

“CO-1686 continues to demonstrate impressive activity and is very well tolerated in these heavily pre-treated patients,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “Additionally, the initial pharmacokinetic and safety data from patients in the ongoing Phase I dose-finding study with the hydrobromide formulation are very promising. We are very optimistic about this new formulation since we are already seeing such encouraging results with an inferior formulation at a suboptimal dose. We look forward to identifying the recommended Phase II dose for CO-1686 and quickly proceeding into our first registration study.”

1 of 4

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 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

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