QIAGEN and Pfizer partner on companion Dx for lung cancer
GERMANTOWN, Md.—QIAGEN announced Aug. 16 that it has entered into a partnership with Pfizer Inc. for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.
Pfizer 's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anticancer drugs.
QIAGEN's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies.
QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the U.S. Food and Drug Administration (FDA) for use with two other, separate drugs targeting metastatic colorectal cancers.
The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow.
The global partnership covers clinical trials and submissions for a PMA application in the United States and the CE mark in Europe, as well as applicable regulatory approvals in other regions.
Following clinical development of the KRAS companion diagnostic for NSCLC, QIAGEN expects to submit a premarket approval application supplement (PMAS) to FDA for full automation of the workflow to allow pathologists easy access and processing of lung tissue samples.