According to the American Society of Clinical Oncology, TAPUR provides patients access to drugs at no cost, and is designed to evaluate FDA-approved targeted agents for indications other than those on the drug’s label.
A press release by the American Society of Clinical Oncology (ASCO) has announced initiation of recruitment for the Targeted Agent and Profiling Utilization Registry (TAPUR) study. The trial, which provides patients access to drugs at no cost, is designed to evaluate FDA-approved targeted agents for indications other than those on the drug’s label. The objective is to use real-world evidence to identify alternative options for patients with advanced disease.
With enrollment underway in Michigan, North Carolina, South Carolina, and Idaho, ASCO plans to expand recruitment across the country by the end of 2016 for patients diagnosed with advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma who have either failed available therapies or do not have a standard therapy available. With the approved targeted drugs currently made available by Bristol-Myers Squibb, Eli Lilly and Company, Genentech, and Pfizer, ASCO expects additional companies to participate following study launch.
“This trial will help evaluate whether certain targeted therapies offer benefits when no established options remain and provide access to these therapies for patients who join,” said ASCO President Julie Vose, MD, MBA, FASCO, in a statement. “With TAPUR, these patients have the potential to benefit from precision medicine strategies that have already demonstrated effectiveness in other selected cancer types. Like other clinical trial participants, they can also help tomorrow's patients.”
Innovative and Flexible Trial Design
Inclusion criteria for the TAPUR study is that the patient’s tumor should harbor at least 1 genomic variant that is potentially targeted by one or more drugs available in the study. Subsequently, the patient will be initiated on a drug included in the study protocol or an alternative option, following consultation with a Molecular Tumor Board. For each specific combination of tumor type, genetic variant, and study drug, 10 participants will initially be enrolled, and enrollment expansion to that study group will be dictated by at least 2 positive responders. An independent Data and Safety Monitoring Board will review the efficacy and safety data.
According to the press release, ASCO has established a Steering Group to oversee the trial, and all the groups, including the Tumor Board and the Data and Safety Monitoring Board, include patients and patient advocates are included in each of these groups.
Emanuel F. Petricoin III, PhD, co-director of the Center for Applied Proteomics and Molecular Medicine at George Mason University, was all praises for the study design of the TAPUR trial. During his presentation at the 4th annual meeting of Patient-Centered Oncology Care in Baltimore last year, he said that TAPUR will ensure access for patients in the community oncology setting. “We’re going to be in a position where we’re not talking about classification by location (of the cancer tumor), but classification by multi-omic analysis,” Petricoin said. “And we’re seeing this in trials like TAPUR, which are starting (in spring 2016), where any oncologist in the community can get tumor profiling and get access now to the drugs.”