Almac and Lilly to develop companion diagnostic for NSCLC drug

Published: 17-Sep-2009

Almac and Lilly UK are developing a companion diagnostic for Alimta and cisplatin as a combination therapy for non-squamous non-small cell lung cancer (NSCLC).


Almac and Lilly UK are developing a companion diagnostic for Alimta and cisplatin as a combination therapy for non-squamous non-small cell lung cancer (NSCLC).

The partners will assess thymidylate synthase (TS) as a predictive marker of response. They will also investigate other predictive biomarkers of response to the combination therapy. Work will include global gene-expression profiling from fresh and formalin fixed paraffin embedded (FFPE) tumour samples using the Almac Diagnostics Lung Cancer DSATM research tool.

The US FDA has approved Alimta in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced NSCLC when surgery is not an option. It is not indicated for patients who have squamous cell NSCLC.

The project will involve a multi-centre, single-arm Phase II study that will recruit patients diagnosed at stage IIIB/IV. Almac's technical team will perform global gene-expression profiling, microRNA profiling, SNP genotyping, qPCR validation, data analysis and project management of the study.

"The final endpoint will be the development of a companion diagnostic test that will select patients likely to benefit from treatment with Alimta," said Northern Ireland-based Almac.

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