Researchers have launched a new study designed to broaden access to drugs for some patients with advanced cancers and to collect and share data on individual responses to drugs that have not yet been approved for their specific cancer types. The Targeted Agent and Profiling Utilization Registry (TAPUR) study is for patients who had genomic tests that revealed their tumors have a mutation that may be treated with drugs approved for other cancers. Participants in the study will have access to those drugs at no cost, even though the drugs have not been approved by the U.S. Food and Drug Administration (FDA) for their cancer type. The trial is being spearheaded by the American Society of Clinical Oncology (ASCO).
The wave of the future
"This is the future of cancer research," says Maurie Markman, MD, President of Medicine & Science at Cancer Treatment Centers of America® (CTCA). "This ASCO-led trial focuses on what we can find within an individual patient's cancer that can help inform what might be the best therapy. Rather than base treatments on large populations of patients, we are looking at the individual patient's tumor. This will be the new paradigm as we move forward."
The goal is to improve the prognosis for patients in the study, which may lead to more FDA-approved drug treatment options for more cancers in the future. “By participating in the TAPUR trial, we hope to learn how well drugs work by targeting mutations in other cancers—types that they are not currently approved for," says Dr. Glen Weiss, Director of Clinical Research and Phase I & II Clinical Trials at our Phoenix-area hospital. "If we see exceptional success, this could lead to new indications for approval and broader access to these drugs, using a path that would likely take longer with traditional clinical trial designs."
TAPUR is a “non-randomized” study, meaning that every eligible participant will be treated with a drug match to his or her tumor, and no participants will receive a placebo. The study is designed to allow for broader participation than most clinical trials, but all patients will be screened to determine if they are healthy enough to participate and meet other eligibility criteria.
Who qualifies for TAPUR?
Qualifying patients must have an advanced solid tumor, multiple myeloma or B-cell non-Hodgkin lymphoma, and have exhausted standard treatments or have no options available to them. Also, because this trial will study only treatments used outside of their FDA-approved indication, patients qualify only if the drugs matched to their mutation have not been approved to treat their cancer type. For example, adult patient "Judy" has lung cancer with a specific mutation identified by a genomic test and she is out of standard treatment options. There is a drug available in the TAPUR study that is designed to target her mutation, but the drug is approved only to treat melanoma, not lung cancer. In TAPUR, she may have access to that drug, but a melanoma patient with the same mutation will not quality for the study.
Seven pharmaceutical companies— Bayer, Merck Sharp & Dohme, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Genentech and Pfizer—are participating in the study, providing a total of 17 drugs. Hospitals around the country, including all five CTCA® hospitals, are enrolling qualified patients.
"What we have here is not just one drug or one molecular abnormality," Dr. Markman says. "We have multiple molecular abnormalities, multiple drugs, multiple companies participating in this trial. This trial changes the entire language of clinical research in cancer. It changes the thought processes for how oncologists treat cancer."
