The two companies announced plans to develop a companion diagnostic to predict whether non-squamous non-small cell lung cancer patients can benefit from combination treatment with Alimta and cisplatin based on the thymidylate synthase biomarker.
According to an editorial in the New England Journal of Medicine, two new studies suggest "that EGFR mutations represent favorable prognostic markers of survival and are predictive of tumor shrinkage, but the evidence that they can predict a differential effect of tyrosine kinase inhibitors on survival is incomplete."
In an interview with Pharmacogenomics Reporter this week, Hakan Sakul provided a snapshot of Pfizer's efforts in personalized medicine, the company's stance on regulatory issues, and its overall focus on "omics"-guided medicine.
Pfizer has previously touted PF-02341066 as "the first agent in clinical development that selectively targets a unique genetic feature of cancer cells." The drug is currently in Phase III trials, while Abbott is in the process of designing validating trials for a companion test with the capability to detect ALK gene rearrangements.
AstraZeneca is working with DxS to commercialize a EGFR mutation test kit in Europe to identify the patient population most likely to benefit from treatment with non-small cell lung cancer drug Iressa. The company has announced no such plans in the US, where the FDA has restricted any new NSCLC patients from receiving the drug.
GSK and Abbott will develop a companion diagnostic for GSK's investigational MAGE-A3 immunotherapy. After discussions with the FDA, GSK believes the drug and diagnostic will be reviewed simultaneously, and labeling language for the drug will require genetic testing prior to treatment.