Multiple pharmaceutical companies for the first time are teaming up to provide therapies for a novel study that may help cancer patients benefit from drugs already approved for other indications.
Precision medicine is entering a new era. Multiple pharmaceutical companies for the first time are teaming up to provide therapies for a novel study that may help cancer patients benefit from drugs already approved for other indications.
The American Society of Clinical Oncology (ASCO) on March 14, 2016, announced it has begun recruiting patients with advanced cancer for its first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR) study. This trial will evaluate molecularly-targeted cancer drugs and collect data on clinical outcomes to help learn additional uses of these drugs outside of indications already approved by the US Food and Drug Administration (FDA).
"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 in an ASCO press release. "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."
The trial will initially enroll participants at 30 clinical sites located in Michigan, North Carolina, South Carolina, and Idaho. Dr. Vose said ASCO plans to expand to other areas of the country by the end of the year. A unique feature of TAPUR is that it will include a broader patient population than in most clinical trials. Eligible participants include those who have an advanced solid tumor, multiple myeloma, or B-cell non-Hodgkin lymphoma that become treatment refractory or no other treatment options are available.
TAPUR will enroll participants whose tumor has at least one genomic variant that is potentially targeted by one or more drugs available in the study. Physicians will select from a set of drugs that is defined in the study protocol or they can consult a Molecular Tumor Board for information about possible treatment options. For each specific combination of tumor type, genetic variant and study drug, 10 participants will initially be enrolled. In groups where at least two participants respond to therapy, enrollment will expand by an additional 18 participants.
An independent Safety and Data Monitoring Board will collect patient data as it pertains to treatment response and treatment-related toxicity associated with the study.
This study is unique because it involves a novel collaboration among different drug companies and will be conducted at various clinical sites: Michigan Cancer Research Consortium, the Cancer Research Consortium of West Michigan, the University of Michigan, and the Carolinas HealthCare System's Levine Cancer Institute. Bristol-Myers Squibb, Eli Lilly and Company, Genentech, and Pfizer will provide the targeted drugs at no cost to participants, as well as additional resources to support the TAPUR study. Additional companies are planning to participate after the study launch.