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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

ASCO '14 Preview: Blood Cancer Data from Pharmacyclics, Gilead, Abbvie

Stocks in this article: GILD ABBV PCYC JNJ

NEW YORK (TheStreet) -- Here is a summary of American Society of Clinical Oncology (ASCO) annual meeting research abstracts released tonight focused on the chronic lymphocytic leukemia (CLL) drugs from Pharmacyclics (PCYC), Gilead Sciences (GILD) and Abbvie (ABBV).


Results from the phase III "RESONATE" study of Imbruvica were not disclosed tonight. The research abstract No. LBA7008 is being withheld for presentation at the ASCO meeting.

Last January, Pharmacyclics and Johnson & Johnson (JNJ) announced the early stopping of the Imbruvica RESONATE study because the primary and secondary endpoints -- progression-free survival and overall survival -- were achieved. The study compared Imbruvica to GlaxoSmithKline's  (GSK) Arzerra in CLL patients no longer responding to at least one prior therapy.

Imbruvica is already approved for use in patients with mantle cell lymphoma and CLL following progression on at least one prior treatment.

Abstract no. 7014 summarizes three-year, follow-up data from a separate study of Imbruvica in 132 CLL/SLL patients, both treatment naive and relapsed/refractory. The updated overall response rate was 78% for all-treated patients (84% for treatment naive, 76% for relapsed/refractory.) In the subgroup of harder-to-treat del(17p) patients, the response rate to Imbruvica treatment was 56%. Median duration of response was 25 months.

Abstract no. 7009 evaluates the combination of Imbruvica and GSK's Arzerra in 71 patients with relapsed/refractory CLL/SLL. Three different dosing schedules of Imbruvica and Arzerra were studied, with an overall response rate of 83%. At 12 months, progression-free survival was 89%, 85% and 90% in the three different dosing schedules; 76% of patients continued receiving Imbruvica in an extension study. Two patients moved to a bone marrow transplant.

Gilead Sciences:

The FDA is currently reviewing two approval applications for idelalisib for the following indications: 1) relapsed/refractory CLL, with a decision is expected on Aug. 6; and 2) refractory indolent non-Hodgkins lymphoma, with an approval decision expected on Sept. 11.

Abstract No. 7011 covers updated results from high-risk subgroups of CLL patients enrolled in the previously presented (and positive) phase III study of idelalisib in combination with Roche's Rituxan.

In patients with del(17p) and TP53 mutations, idelalisib+Rituxan achieved a 76.5% overall response rate and a progression-free survival hazard ratio of 0.13 (87% reduction in the risk of progression.) This compares to an 80.4% overall response rate and a PFS hazard ratio of 0.17 for patients negative for del(17p) and TP53.

Overall results from a second interim analysis of the idelalisib+Rituxan phase III study in CLL are summarized in abstract no. 7012. Treatment with idelalisib+Rituxan reduced the risk of tumor progression by 82% compared to Rituxan+placebo. The risk of death was reduced by 72% favoring the idelalisib.

Gilead also has a selective Syk inhibitor, GS-9973, in clinical development for CLL. Abstract no. 7007 summarizes a phase II study enrolling 44 patients with relapsed/refractory CLL and treated with twice-daily, 800 mg dose of GS-9793. Results: 40 of 41 evaluable patients (91%) experienced reduced tumor bulk; 64% achieved tumor reduction of 50% or more, according to the investigator review. Twenty-seven patients are still on treatment for a median of 22 weeks.

Two patients died while on the study, one from progressive disease, one from sepsis. The most common adverse events reported (all grades) were diarrhea (48%), fatigue, nausea and headache.

Abstract no. 7059 reports on a study combining GS-9793 with idelalisib in CLL and NHL patients. After 66 patients were enrolled, the study was stopped due to reports of severe, steroid-responsive pneumonitis in 9 patients. Reversible grade 3/4 liver enzyme elevations occurred in 15% of patients. Five patients died during the study -- two from disease progression, one from pneumonitis, one from pneumonia and one from sepsis.


Abstract no. 7013 reports on a phase I study of ABT-199 combined with Rituxan in relapsed/refractory CLL patients. Thirty-seven patients were treated in five dose cohorts. Eighteen patients were evaluable for efficacy, with 7 patients (39%) achieving a complete response and 7 patients (39%) achieving a partial response. Minimal residual disease (MRD) found in 6 of 7 patients, while 5 patients were MRD negative. Of 19 patients still being treated with combination therapy, 4 have confirmed partial response and 9 have unconfirmed partial response.

One patient died due to hyperkalemia in the setting of tumor lysis syndrome. The common grade 3-4 adverse events reported were neutropenia (43%), thrombocytopenia (16%) and anemia (11%.)

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

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!


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

  • 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