How ASCO, Palmetto propose to use cancer genomics to choose off-label therapies
The American Society of Clinical Oncology and a group being organized by Medicare contractor Palmetto GBA plan to launch separate initiatives next year that will use registries to collect and disseminate evidence on personalized cancer treatments for rare mutations while facilitating access to off-label drugs. Success could lead to wider coverage and use of molecular diagnostics and targeted therapies, and evidence about the prevalence of tumors that are susceptible to targeted therapies.
The efforts also could provide insights into how well molecular diagnostics perform in the real world, including the ability of physicians to interpret test results.
ASCO's Targeted Agent and Profiling Utilization Registry (TAPUR) and the Molecular Evidence Development Consortium (MED-C) each will match data on tumor genetics with potentially effective targeted therapies. Both initiatives are intended to increase the diagnoses of patients with rare mutations, as well as treatment of these patients with drugs that are approved to treat other types of cancer that harbor the same mutation.
ASCO CMO Richard Schilsky and Dane Dickson, who is acting CEO of MED-C, told BioCentury efforts like TAPUR and MED-C are needed because it will take years to complete and analyze studies attempting to prospectively match tumor mutations to investigational and/or approved targeted therapies, but there is an immediate need for patients to receive effective treatments and to systematically collect real-world outcomes data.
The cost of diagnostic tools such as next-generation sequencing is declining, and inventories of diagnostics and targeted therapies are growing, but the data and tools for making clinical, reimbursement and regulatory decisions are not keeping up with the opportunities to experiment with biologically plausible off-label cancer treatments.
Additionally, data on the analytical and clinical validity of tests