Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Geron Halts Phase 2 Study Of Imetelstat In Metastatic HER2negative Breast Cancer

RELATED NEWS
Trade GERN now with 
9/10/2012 8:09 AM ET

Geron Corp. (GERN: Quote) announced that, on the basis of an unplanned interim analysis, it is discontinuing its randomized Phase 2 study of imetelstat in metastatic HER2-negative breast cancer because median progression-free survival or PFS in the imetelstat arm was shorter than in the comparator arm.

The company also announced that it is continuing its randomized Phase 2 study of imetelstat in advanced non-small cell lung cancer or NSCLC.

However, the company said that although a separate interim analysis of the NSCLC study suggested a modest trend of efficacy in favor of the imetelstat arm, the pre-specified success criteria in this trial are unlikely to be met, and, as a consequence, it is doubtful that Geron will take imetelstat forward into Phase 3 development for NSCLC.

The study in metastatic HER2-negative breast cancer was a randomized, controlled trial of 166 patients in which imetelstat was evaluated in combination with paclitaxel, compared to paclitaxel alone. The primary efficacy endpoint was an estimate of PFS.

In this trial, a scheduled periodic review conducted by Geron's Internal Safety Monitoring Committee reported a greater number of deaths and number of patients discontinuing paclitaxel in the imetelstat arm compared to the control arm.

Based on these observations, an unplanned interim analysis of efficacy was performed that showed a median PFS of 6.2 months for patients receiving treatment with imetelstat in combination with paclitaxel, compared to 8.0 months for patients receiving paclitaxel alone (hazard ratio = 1.62; p = 0.028).

The company said it is evaluating imetelstat in two hematologic malignancies: essential thrombocythemia or ET and multiple myeloma. Using biomarkers, these two studies are designed to evaluate whether inhibiting telomerase will selectively reduce the proliferation of the malignant progenitor cells responsible for these diseases. In the ET trial, the company is also evaluating clinical and hematological responses. Geron continues to expect to release top-line results from these studies in the fourth quarter of this year.

Register
To receive FREE breaking news email alerts for Geron Corporation and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Chipmaker Advanced Micro Devices Inc. said Thursday after the markets closed that its first quarter loss narrowed from last year, helped by strong revenue growth in its graphics and visual solutions business. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue. After trending higher over the past few sessions, stocks showed a lack of direction throughout the trading day on Thursday. The major averages spent the session bouncing back and forth across the unchanged line before ending the day mixed. While the major averages closed on opposite sides of the unchanged line, they all showed only modest moves. U.S. Secretary Of State John Kerry said Thursday that he and his counterparts from Russia, Ukraine and the European Union have reached an agreement on a preliminary plan for ending the ongoing crisis in Ukraine. Kerry was speaking at the end of the Ukraine contact group's first meeting, comprising the foreign ministers of Russia, Ukraine, the EU and the U.S., in the Swiss city of Geneva.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.