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

Merrimack Pharmaceuticals Announces Results From A Phase 2 Study Of MM-121 (SAR256212) In Combination With Paclitaxel In Patients With Platinum-Resistant Or Refractory Advanced Ovarian Cancers

Stocks in this article: MACK

CAMBRIDGE, Mass., Oct. 30, 2013 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) today announced results of a global, Phase 2, open-label, randomized study of MM-121 in combination with paclitaxel versus paclitaxel alone in patients with platinum-resistant or platinum-refractory advanced ovarian cancers.

This study did not meet the primary endpoint of progression free survival in the overall population.  The hazard ratio (HR) for progression free survival (PFS) was 1.0 [95% CI 0.74 - 1.4].

Ongoing analysis of a pre-specified set of biomarkers mechanistically linked to ErbB3 signaling identified a potential subpopulation of patients benefiting from MM-121 treatment in combination with paclitaxel. When using a combination of two biomarkers, the hazard ratio for PFS was 0.37 [95% CI 0.2 - 0.8] in the 34% of patients who were biomarker positive. The hazard ratio for PFS in the biomarker negative population was 1.54 [95% CI 1.0 - 2.4].

An overall increase in all grades of gastrointestinal toxicities, including diarrhea (73.6% vs. 42.5%), vomiting (31.4% vs. 18.8%) and other mucosal toxicities such as rhinitis (7.1% vs. 1.3%), epistaxis (23.6% vs. 17.5%), stomatitis (22.1% vs. 10.0%) and mucosal inflammation (22.1% vs. 1.3%), were observed in the combination as compared to paclitaxel alone, the majority of which were mild to moderate in severity. An increase in the pulmonary embolism rate was observed with the combination of MM-121 and paclitaxel (5.0% vs. 1.2%). No enhancement of paclitaxel-related peripheral neuropathy was reported with the combination.

"This unique study design lays the groundwork for future translational studies in ovarian cancer. The rapid enrollment into this study was a testament to the commitment of patients and physicians to advance our knowledge and improve upon available therapies in advanced ovarian cancers," said Dr. Akos Czibere, Clinical Director of the MM-121 program at Merrimack. "These data are a step forward for women with ovarian cancer." 

"Research at Merrimack and elsewhere has shown that ligand-driven signaling through ErbB3 is one way in which cancer cells become resistant to therapy," said Gavin MacBeath, Ph.D., Co-Founder and Vice President of Translational Research at Merrimack. "MM-121 was designed to block this pathway. We are particularly encouraged by the biomarker findings in this trial, which are consistent with our preclinical hypotheses. This gives us increased confidence in our network biology platform and in our translational program at Merrimack."

This study was designed to evaluate whether MM-121 in combination with paclitaxel is more effective than paclitaxel alone, based on progression free survival. Patients were randomized at a 2:1 ratio for MM-121 in combination with paclitaxel versus paclitaxel alone. The study was conducted in the United Stated and Europe, and 223 patients were randomized. Patients enrolled in this study had locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, had received at least one prior platinum-based chemotherapy regimen, and were platinum-resistant or refractory. The full data from the study will be presented at a future conference.

MM-121, in partnership with Sanofi, is also being evaluated in second line ER/PR+ metastatic breast cancer, ER/PR+ neoadjuvant breast cancer, triple-negative neoadjuvant breast cancer and non-small cell lung cancer.

1 of 2

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!
DOW 16,399.67 +19.26 0.12%
S&P 500 1,904.01 +17.25 0.91%
NASDAQ 4,316.0740 +57.6360 1.35%

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