A new way of evaluating tumors may soon help cancer patients identify the underlying genetic link to their disease - and the best possible treatment - all in a single test.
Researchers are set to begin clinical trials using a more comprehensive testing method that looks for all of the known genes that may be active in a tumor.
The new method could guide patients to the right drug earlier, potentially replacing current tests known as companion diagnostics that only look for a specific biological trait or "biomarker." The presence of a biomarker can predict whether a new class of drugs called targeted therapies will work on particular tumors.
Results of these broader tests could even be used to quickly identify which patients might benefit from experimental drugs being tested in clinical trials. U.S. health officials see it as the future direction of cancer diagnostics.
"We really are moving away from this one drug, one biomarker, one companion diagnostic," said Dr Richard Pazdur, the U.S. Food and Drug Administration's oncology chief.
In advanced melanoma, for example, about half of patients' tumors have a mutation in the BRAF gene. Roche makes a drug called Zelboraf that blocks that pathway, at least for a time. To get Roche's drug, patients need to be evaluated with an FDA-approved companion diagnostic test. One of the tests is also made by Roche.
In many cases, the FDA requires single-biomarker companion diagnostics as part of the drug approval process, but the broader testing model opens the door to additional players in the diagnostics space, including U.S.-based Foundation Medicine Inc and Thermo Fisher's Life Technologies.
In a trial starting later this month, for example, patients with squamous cell carcinoma of the lung could be recommended for one of five experimental treatments based on which genes are active. Foundation Medicine's next-generation sequencing platform will be used to screen some 6,000 lung cancer patients over five years.
The Lung Master Protocol trial, also known as Lung-MAP, will take place in some 400 research centers. It is a public-private partnership between the National Cancer Institute, Amgen Inc , AstraZeneca Plc and its U.S.-based biotech arm MedImmune, Roche's Genentech unit and Pfizer Inc.
A similar effort called the National Lung Matrix trial being organized in Britain by AstraZeneca, Pfizer and Cancer Research UK is set to start taking patients in July or August. Pazdur said a conference this fall will also discuss plans for a trial in metastatic breast cancer.