"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.
Insight is developing the tests using TaqMan probes on Life Technologies' ABI 7500 Fast Dx real-time PCR system to help physicians monitor cancer patients for mutations and upregulation in the ALK gene in order to make more effective treatment decisions.
In the study, out of three patients with ALK gene rearrangements, two responded partially to Infinity's investigational drug IPI-504, and one experienced prolonged stable disease while on the treatment for 7.2 months and had a 24 percent reduction in tumor size.
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.