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
TheStreet Open House

Data Presented At American Society Of Hematology From Ibrutinib Phase 1b/2 And Phase 2 Trials Suggest High And Durable Response In Chronic Lymphocytic Leukemia

Stocks in this article: PCYC

ATLANTA, Dec. 8, 2012 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced follow-up results that its investigational oral therapy ibrutinib (PCI-32765), as a single agent, resulted in durable responses for patients over 65 years of age with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and for those with relapsed/refractory (RR) or high-risk (HR) disease.

In a study of 116 patients, the overall response rate (ORR) was 68 percent in elderly treatment-naive (TN) patients with an estimated 96 percent progression-free survival (PFS) rate at 26 months. In patients with RR CLL/SLL, including those with HR disease, the ORR was 71 percent with an estimated PFS at 26 months of 75 percent.

A second study in 40 patients with HR CLL treated with the combination of ibrutinib and rituximab therapy reported an ORR of 83 percent, with 38 of the 40 patients continuing on therapy without disease progression. Patients with HR disease have inferior responses to standard chemo-immunotherapy and shorter rates of PFS and OS.

These findings, from ongoing Phase 1b/2 and Phase 2 trials, were presented in a press briefing today at the 54 th annual meeting of the American Society of Hematology in Atlanta, GA. CLL and SLL are common B-cell non-Hodgkin lymphomas.

In describing the findings of the Phase 1b/2 ibrutinib monotherapy trial, lead investigator John C. Byrd, M.D., said, "We are very encouraged that these results with ibrutinib continue to support the possibility that we can address some of the critical unmet needs in CLL/SLL." Dr. Byrd is the D. Warren Brown Chair of Leukemia Research and Director, Division of Hematology at Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC — James).

In his presentation, Dr. Byrd noted that current therapies have a number of limitations in terms of how long they can be used in a patient and their tolerability, especially in elderly patients. "Further, virtually all patients relapse, and there are few salvage regimens that produce durable remissions," he pointed out.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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!

Markets

DOW 17,387.21 -291.49 -1.65%
S&P 500 2,029.55 -27.54 -1.34%
NASDAQ 4,681.4970 -90.2660 -1.89%

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