FONT-SIZE Plus   Neg

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

Geron Corp. (GERN) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Microsoft's (MSFT) office assistant Cortana for iOS beta has arrived, but only 2000 people will be able to test the virtual assistant. Apple confirmed that it has bought face animation software firm Faceshift, although it was tight lipped about how it intends to use the new addition. The move is speculated as a bid to expand into virtual reality. Environment ministry of South Korea Thursday ordered Volkswagen Korea to recall 125,522 diesel vehicles on determining actual emissions of nitrogen oxides. The ministry has asked the German automobile maker to pay a fine of 14.1 billion Won or $12.31 million. The company has to submit a recall plan by January 6, 2016.
comments powered by Disqus
Trade GERN now with 
Follow RTT