By Turna Ray
Cancer Research UK will apply more than £5.5 million ($8.8 million) in industry funding to carve out a national system by which multi-gene diagnostics can be more readily accessible to doctors who want to use genomic data to personalize cancer treatment.
The aim of the so-called Stratified Medicine Program, funded by AstraZeneca and Pfizer, is to "establish a national service making standardized, high-quality, cost-effective genetic testing of tumors available for people with cancer," Cancer Research UK states on its website. "So, as and when targeted treatments become available, doctors will have access to the tests needed to help them decide the most suitable drugs for each individual patient."
By bringing together hospitals and genetic testing labs, Cancer Research UK is hoping to develop an improved model for genetically testing patients' tumors, which could be scaled up for use in the UK's National Health Service. Additionally, through the Stratified Medicine Program, Cancer Research UK will also develop a database linking patients' genomic profiles with their clinical information, which will allow researchers and drug developers to incorporate gene markers in drug development programs and develop personalized cancer treatments.
In the first phase of the project, from 2011 to 2013, six hospitals collaborating with Cancer Research UK in the project will collect 9,000 samples from patients who have agreed to be in the study and have the following cancer types: breast, bowel, lung, prostate, ovary, and melanoma. These samples will then be sent to centralized labs, where they will be analyzed for genetic biomarkers that have been agreed upon by Cancer Research UK's advisory group. Genetic testing results will be sent back to the hospitals and stored, creating population-level clinical and genetic data sets to inform research.
According to a Cancer Research UK spokesperson, there is no restriction on the types of technologies labs can use to analyze patient samples. Labs can indicate the type of testing they will perform in their applications to be part of the program. Applications must be submitted by March 8, at which point Cancer Research UK will select the labs and hospitals it will work with to conduct the project.
"What we're trying to demonstrate is [that] if physicians have genetic test results back in a timely fashion, then they will be able to make treatment decisions based on those results," said Alice Tuff, the project manager for the Stratified Medicine Program.
In the first phase of the project, however, doctors will not make treatment decisions based on genetic test results. In developing its model for genetic testing, Cancer Research UK "will not conduct research on drugs and participation in the program will have no effect on what treatment the patients receive," said James Peach, director of the Stratified Medicine Program. "Clinicians will receive the results of the genetic tests and may use this information to inform their patients about potential clinical trials they could be involved in."
Investigators will aim to release the data gathered from the first phase of the Stratified Medicine Program "as quickly as we can into the public domain," Tuff told PGx Reporter. "Once we get the data validated, it has to go out to the public within six months."
In the second phase, Cancer Research UK hopes to use the lessons learned from the first phase to implement a national system for providing genetic testing in the country. "Ultimately this will lead to a national standardized, high-quality and cost-effective genetic testing service and a research database that continues to grow and inform research," Cancer Research UK states on its website.
Cancer Research UK is conducting this project with input from the UK's NHS, the National Institute for Health and Clinical Excellence, and another governmental body called the Technology Strategy Board in anticipation that genomically targeted treatments will be a critical component of patient care in the UK in the coming years. "Although some hospitals in the UK already do some genetic testing, there is actually no national system for doing this that is standardized, quality assured, or cost-effective," Tuff said. "So, what we're trying to do is refine the service model behind genetic testing and demonstrate how this can be done on a national scale."
Cancer Research UK's efforts regarding genetic testing come as the UK government is developing new procedures for evaluating the clinical value of molecular diagnostics that would enable personalized treatments. For example, NICE's recently formed Diagnostics Advisory Committee recently announced it was seeking specialists to inform its clinical and cost-effectiveness review of the Randox Breast Cancer Array, a test that analyzes 23 genes to classify tumors into molecular subtypes, which can help doctors make treatment decisions.
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"The assessment of Randox BCA may be expanded during the scoping phase to include other multi-gene expression tests for the subtyping of breast cancer," NICE said in a statement. NICE evaluates the clinical and cost effectiveness of treatments and makes recommendations to NHS about which medical interventions it should pay for and make available within the UK.
Separately, the Technology Strategy Board is working with NICE, Cancer Research UK, and others to advance targeted treatments. The board has pledged £50 million ($80 million) for a five-year period to support the development of stratified medicine products.
Additionally, the Technology Strategy Board has launched a competition for industry-led groups to develop test panels that can simultaneously detect validated mutations in common cancer types. Additionally, companies can apply for funding to develop IT systems for linking clinical and genetic data. The board plans to award £5.6 million ($9 million) to support these two efforts.
The long-term goal of the Stratified Medicine Program is to develop a multi-gene cancer panel that will guide the administration of several pharmacogenomically guided cancer drugs.
“The program aims for a standardized multi-gene panel to be developed to make genetic testing more reliable, cheaper, and more efficient," said Peach. "We have consulted with cancer clinicians, researchers, and drug developers in the UK and internationally to understand which markers are the most likely to be used now and in the near future, which led to the proposed list of markers on the panel."
Furthermore, a national database linking genetic and clinical information will be an invaluable resource for drug developers, enabling stratified clinical trials and the identification of potential study participants earlier in the process. Sponsors AstraZeneca and Pfizer are both investing in developing genomically targeted personalized medicine products, and the collaboration with Cancer Research UK will likely inform their drug development efforts.
AstraZeneca sells its NSCLC drug Iressa in the UK to patients who have tumors with EGFR mutations (PGx Reporter 06/02/10). The drug maker is also working with Myriad Genetics to develop companion tests for the PARP inhibitor olaparib that it is developing in breast and ovarian cancer (PGx Reporter 06/30/10).
Pfizer, beyond its funding role in the Stratified Medicine Program, has a drug in its pipeline that it jointly developed with Newcastle University and Cancer Research Technology, the technology development and commercialization arm of Cancer Research UK. The drug giant is planning to use a methylation test developed by MDxHealth to identify best responders to the PARP inhibitor PF-01367338 in breast and ovarian cancer (PGx Reporter 02/02/11). Other oncology treatments that Pfizer is advancing with a pharmacogenomics strategy include crizontinib in NSCLC, Sutent in renal cancer, tremelimumab in melanoma, PF-04948568 in glioblastoma, and bosutinib in chronic myeloid leukemia.
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