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!

Ibrutinib Study Results In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia Published In The New England Journal Of Medicine

Stocks in this article: PCYC

SUNNYVALE, Calif., June 19, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today announced that The New England Journal of Medicine ( NEJM) published results online of a Phase 1b/2 study evaluating the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib was shown to be safe and effective in patients with relapsed/refractory CLL or SLL, even in patients who were at high-risk due to factors such as deletion of part of chromosome 17 (del 17p).

Results of a separate study examining the safety and efficacy of ibrutinib monotherapy for the treatment of relapsed/refractory mantle cell lymphoma (MCL) has also been published online in NEJM today. Pharmacyclics sponsored both studies and is jointly developing ibrutinib with Janssen Research & Development, LLC.

The open-label study reported on 85 patients with relapsed/refractory CLL or SLL. The majority of patients had advanced disease and had previously undergone treatment with several rounds of therapies before enrollment in the study. Approximately one-third of patients enrolled in the study presented with a malignancy carrying del 17p. Patients with del17p typically respond poorly to chemoimmunotherapy, which is the current standard treatment for CLL.

"Patients with CLL and SLL have a great need for new, well tolerated and effective therapies," said lead author John C. Byrd, M.D., Director, Division of Hematology, D Warren Brown Professor of Leukemia Research, The Ohio State University Comprehensive Cancer Center. "These data are particularly exciting, as they demonstrate benefit for high risk CLL and SLL patients, with efficacy consistent across doses and continuing durable remissions lasting in excess of two years in the great majority of patients treated."  

Study participants were enrolled selected to receive either ibrutinib 420 mg (n=51) or 840 mg (n=34) as a once-daily, oral monotherapy. Both doses were associated with overall response rates of 71 percent. Del17p patients had an overall response rate of 68 percent. Two patients in the 420 mg dose arm had complete responses and 34 patients had partial responses. Across all relapsed or refractory patients, including the high risk patients, the estimated progression-free survival at 26 months was 75 percent. An additional 20 percent of patients treated with the 420 mg dose and 15 percent of patients taking the 840 mg dose achieved a partial response accompanied by lymphocytosis, an elevated blood lymphocyte count.

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 18,030.21 +6.04 0.03%
S&P 500 2,081.88 -0.29 -0.01%
NASDAQ 4,773.4720 +8.0480 0.17%

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