Eli Lilly has signed on Almac to develop a companion diagnostic for use along with Alimta and cisplatin combination therapy for nonsquamous non-small-cell lung cancer (NSCLC). The firm will assess thymidylate synthase (TS) as a predictive marker of response.
The firm will also investigate and try to identify other predictive biomarkers. Strategies will include global gene-expression profiling from FFPE tumor samples using the Almac Diagnostics Lung Cancer DSA™ research tool. This high-density array is based on the transcriptome of an individual disease and so will maximize the data selected from the specific disease setting, allowing Lilly to obtain more reliable and relevant gene-expression information that would not be available on a generic array, according to Almac.
The project will involve a multicenter, single-arm Phase II study that will recruit patients diagnosed at stage IIIB/IV. Almac’s technical team will perform global gene-expression profiling, miRNA profiling, SNP genotyping, qPCR validation, data analysis, and project management of the study.
Alimta was originally approved in 2004 in combination with cisplatin for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curative surgery. It was also sanctioned as a single agent for the second-line treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy.
In 2008 Alimta in combination with cisplatin received the go-ahead as a first-line treatment for locally advanced or metastatic NSCLC for patients with nonsquamous histology. At the time of the first-line approval, the FDA also changed the second-line indication. Alimta is now indicated as a single agent for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC after prior chemotherapy.