QIAGEN 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
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 anti-cancer drugs.
QIAGEN’s proposed companion diagnostic will be based on its
proprietary KRAS assay technology, which reliably 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 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.
QIAGEN and Pfizer will engage in collaborative efforts to
develop the KRAS companion diagnostic for use with dacomitinib (PF-00299804).
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.
“We are pleased to collaborate with Pfizer seeking to
advance personalized healthcare with a new potential tool in the fight against
non-small cell lung cancer, a major killer around the world,” commented
Dr. Stephen Little, Vice President Personalized Healthcare at QIAGEN.
“This partnership unites QIAGEN’s capabilities in companion diagnostics
with Pfizer’s scientific excellence and global presence to develop an
innovative diagnostic-therapeutic combination with the potential to improve the
standard of care for NSCLC patients.”