Telik Telcyta vs. Iressa
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Telik initiates a Phase III registration trial comparing its apoptosis-inducing oncologic Telcyta to AstraZeneca's Iressa for single-agent, third-line treatment of non-small cell lung cancer. ASSIST-2 (Assessment of Survival In Solid Tumors-2) will randomize 520 patients to either Telcyta (TLK286) or Iressa (gefitinib); endpoints include survival, time to tumor progression and objective response rate. Another registration trial, in women with resistant ovarian cancer (ASSIST-1), is underway. Other ongoing studies include combination regimens in NSCLC and ovarian cancer, and a single-agent study in previously untreated metastatic breast cancer. ASSIST-1 and -2 are both under special protocol assessments with FDA, Telik notes. Telcyta has fast-track designation for both indications...