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

Quick Facts

Editors Pick
The Reserve Bank of New Zealand on Thursday raised its Official Cash Rate by 25 basis points, to 3.00 percent from 2.75 percent. The decision was in line with expectations, and it marks the second straight month with a rate hike following 24 straight meetings in which the rate was not changed. New Zealand's economic expansion has considerable momentum, with GDP estimated to have grown by 3.5 percent in the year to March. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter. Stocks moved mostly lower during trading on Wednesday, giving back some ground after trending higher over the past several sessions. Selling pressure was relatively subdued, however, limiting the downside for the markets. The major averages all closed in the red, although the tech-heavy Nasdaq underperformed its counterparts by a wide margin.
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.