Pfizer Allies with Qiagen to Develop Companion Diagnostic for NSCLC Drug Candidate

Pfizer has teamed up with Qiagen to develop a companion diagnostic for use alongside its investigational compound, dacomitinib (PF-00299804), which is currently undergoing Phase III clinical development for the treatment of non-small cell lung cancer (NSCLC). Dacomitinib is an oral Her-1, Her-2, and Her-4 tyrosine kinase inhibitor. The proposed companion diagnostic, based on Qiagen’s KRAS assay technology, will be used to identify patients with wild-type KRAS who are generally most likely to respond to EGFR inhibitor therapy. 

Within the last month Qiagen has submitted PMA applications to FDA for approval of KRAS companion diagnostics alongside two separate drugs targeting metastatic colorectal cancer. The diagnostic in development for Pfizer’s dacomitinib will be designed specifically for use with lung cancer tissue. Qiagen says it will be based on the same core assay technology used in its therascreen^® KRAS RGQ kit for colorectal cancers, but adapted for lung tissue-specific sample technology in a fully automated workflow. 

Under terms of the deal with Pfizer, the firms will collaborate on development of the dacomitinib companion diagnostic including clinical trials and submissions for a PMA application in the U.S., a CE mark in Europe, and regulatory approvals in other countries. 

Earlier this month Qiagen submitted a PMA for its therascreen KRAS RGQ PCR Kit for use as a companion diagnostic with Erbitux^® (cetuximab) in the treatment of metastatic colorectal cancer. In July the firm submitted its first PMA for use of the KRAS assay alongside a separate drug for the treatment of colorectal cancer. 

Qiagen is separately working with Boehringer Ingelheim to develop a companion diagnostic for use alongside the firm’s tyrosine kinase inhibitor TomTovok® in patients with NSCLC, and has also partnered with AstraZeneca to generate a test for use in combination with the NSCLC drug Iressa®. 

In June Qiagen made a bid to acquire cancer molecular diagnostics specialist Ipsogen for about $101 million in cash. Then, in July, the firm increased by 7% a previous bid to acquire Australian diagnostics firm Cellestis from A$3.55 per share (equating to an A$341 million purchase price) to A$3.80 per share. Acquisition of Ipsogen will give Qiagen a range of assays covering 15 biomarkers for the diagnosis, prognosis, and monitoring of blood cancers. Most of Ipsogen’s tests have been granted a CE-IVD mark in Europe, and can be used on Qiagen’s Rotor-Gene Q real-time PCR system. 

Qiagen wants to buy Cellestis to get its hands on the firm’s QuantiFERON® technology for disease detection and monitoring, including its clinical-use QuantiFERON-TB Gold (QFT) blood test for diagnosing tuberculosis infection, and QuantiFERON-CMV test for cytomegalovirus infection, which has been CE marked as an IVD in Europe.