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!

Genmab Announces Top-Line Phase II Results For Ofatumumab Combined With Bendamustine In Untreated And Relapsed Chronic Lymphocytic Leukemia

Company Announcement

  • 95% overall response rate and 43% complete response rate in patients with previously untreated chronic lymphocytic leukemia
  • 74% overall response rate and 11% complete response rate in relapsed chronic lymphocytic leukemia
  • Treatment was well tolerated with 87% of patients completing the full treatment course

COPENHAGEN, Denmark, May 1, 2013 (GLOBE NEWSWIRE) -- Genmab A/S (Copenhagen:GEN) announced today top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).

A total of 97 patients were treated in the study and 87% of patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%.  The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%.  Treatment with ofatumumab and bendamustine was well tolerated by patients in the study . The most common adverse reactions (>20% of patients) were neutropenia, nausea, rash, pyrexia and thrombocytopenia.

"These data show encouraging clinical responses in patients treated with ofatumumab plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL.  This is only the first set of key data we expect to report for ofatumumab over the next 15 months.  Data from five pivotal studies are due during this time period, including results from a  Phase III study of ofatumumab in front line CLL during the first half of 2013," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the study

This Phase II study included patients who had untreated and  relapsed CLL.  Patients in the study were treated with a maximum of 6 cycles of study treatment. All subjects received 3 cycles of ofatumumab plus  bendamustine and were eligible for additional treatment cycles dependent upon response to treatment.  The primary objective of the study was to evaluate the investigator-assessed overall response rate according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCIWG) guidelines, in two populations: subjects with untreated CLL and subjects with relapsed CLL treated with ofatumumab plus bendamustine.

1 of 3

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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

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