Lilly Alimta begins Phase III for small-cell lung cancer
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly is enrolling patients in a Phase III global, open-label study evaluating Alimta (pemetrexed) in extensive-stage small-cell lung cancer. The trial, known as GALES (Global Analysis of Pemetrexed in SCLC Extensive Stage) will enroll roughly 1,820 subjects to assess the antifolate in combination with carboplatin compared to etoposide in combination with carboplatin. Overall survival is the primary endpoint. The study will use pharmacogenomic analysis to assess potential biological characteristics to match possible better responders to the treatment. On Nov. 13, the U.K. National Institute for Health & Clinical Excellence recommended against the use of Alimta for non-small cell lung cancer, based upon results of survival data compared to less expensive treatment options...