AstraZeneca Partners With QIAGEN, Roche to Develop Companion Diagnostics for Lung Cancer Drugs

AstraZeneca has announced new collaborations with QIAGEN and Roche to create 2 separate, noninvasive companion diagnostic tests to be used with 2 of its drugs for NSCLC, gefitinib (IRESSA) and AZD9291.

AstraZeneca has announced new collaborations with QIAGEN and Roche to create 2 separate, noninvasive companion diagnostic tests to be used with 2 of its drugs for non-small cell lung cancer (NSCLC), gefitinib (IRESSA) and AZD9291.

Both gefitinib and AZD9291 are inhibitors of the epidermal growth factor receptor (EGFR), a tyrosine kinase receptor that is frequently found to have abnormally high levels of activity in NSCLC cells due to an activating mutation (EGFRm+).

Gefitinib is currently approved in 65 countries, including the European Union, for patients with locally advanced or metastatic EGFRm+ NSCLC, therefore determining the presence of the EGFRm+ mutation in a patient’s tumor is necessary before beginning treatment.

Presently, the mutational status of EGFR in a patient with NSCLC is determined by testing a tissue sample from the tumor collected by needle biopsy or after surgical resection. These invasive procedures complicate patient care, and in some cases it is not possible to collect sufficient tissue for mutational testing.

QIAGEN’s new companion diagnostic will enable doctors to use a blood sample to identify those patients with EGFRm+ NSCLC, ie, those most likely to benefit from gefitinib treatment. The test uses a highly sensitive assay to detect EGFR sequences in fragments of circulating tumor DNA (ctDNA) found in plasma taken from patients’ blood samples.

“We are excited about this new partnership with AstraZeneca,” Peer M. Schatz, CEO of QIAGEN, said in a statement. “Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards.”1

Most patients that receive EGFR inhibitors will eventually develop resistance due to additional mutations. TheT790Mmutation is one of the most common and is found in about 50% of patients who no longer respond to EGFR inhibitors. There are currently no targeted therapies approved for use in cancers with this mutation.

AZD9291 is an investigational compound that irreversibly inhibits EGFR with both the activating mutation and theT790Mresistance mutation, but has no effect on wild type EGFR. There have been encouraging results in a phase I trial of AZD9291 in patients with theT790Mmutation,2and a plasma-based screening diagnostic would allow AstraZeneca to quickly enroll new patients should they embark on a larger trial.

Currently, testing for theT790Mmutation in patients who have progressed on EGFR inhibitors requires a repeat biopsy, an invasive and time-consuming procedure. The new diagnostic under development with Roche is designed to identify EGFR mutations in both tumor tissue and plasma samples, accelerating the process of identifying patients with the keyT790Mmutation.

“We are committed to developing targeted medicines that improve health outcomes for patients,” Mondher Mahjoubi, senior vice president, global product strategy for oncology at AstraZeneca, noted in a statement. “Understanding the nature of each individual’s tumor and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are diagnosed and treated.”3


  1. AstraZeneca. AstraZeneca and QIAGEN enter collaboration to develop diagnostic test for lung cancer patients suitable for treatment with IRESSA. Accessed August 5, 2014.
  2. Janne PA, Ramalingam SS, Yang JC, et al. Clinical activity of the mutant-selective EGFR inhibitor AZD9291 in patients (pts) with EGFR inhibitor—resistant non-small cell lung cancer (NSCLC).J Clin Oncol. 2014;32:5s (suppl) Abstract 8009.
  3. AstraZeneca. AstraZeneca and Roche announce partnership to develop companion diagnostic test for AZD9291. Accessed August 5, 2014.