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TAPUR trial has potential to be ‘a win–win’
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The TAPUR trial, the first clinical trial launched by ASCO, is underway at 38 centers in five states.
The nonrandomized trial — the acronym for which stands for Targeted Agent and Profiling Utilization Registry — is designed to investigate the use of FDA–approved, molecularly targeted cancer therapies in patients with advanced cancers that have actionable genomic variants.
The trial is open to patients with solid tumors, multiple myeloma or B-cell non-Hodgkin lymphoma who either are no longer responding to standard therapies or for whom standard treatments do not exist.
As of June, 49 participants had registered.
“Each site has been actively genomic testing and enrolling patients into treatment,” Edward S. Kim, MD, chair of the department of solid tumor oncology at Levine Cancer Institute at Carolinas HealthCare System and chair of the TAPUR steering committee, told HemOnc Today. “The enrollment thus far has been very good. ... Our physicians believe the study is an important one for patients.”
Kim, a HemOnc Today Editorial Board member, discussed the goals of the trial and its potential impact on patients.
Q: How many sites are involved?
A: The TAPUR study has been activated at 38 centers at four sites across the country. Three are in Michigan — the Cancer Research Consortium of West Michigan, the Michigan Cancer Research Consortium and the University of Michigan — and one, Levine Cancer Institute at Carolinas HealthCare System, is in North Carolina.
Q: What are short-term plans?
A: Richard L. Schilsky, MD, FASCO, FACP, chief medical officer of ASCO and principal investigator of the study, has received a lot of positive feedback about the study and its objectives. There has been a lot of interest from multiple centers across the country. The short-term plan is to continue to activate additional sites. We really like the study because it offers patients an opportunity to be treated with an approved drug based upon a biomarker, but not approved in the setting of disease that they have. It really is a trial that allows for options both for the treating physician and the patient. It is based not only on a general nontargeted drug, but adding at least some basic rationale into using biomarkers to direct therapy. We live in the era of precision medicine and TAPUR helps us practice this.
Q: What are long-term plans?
A: We anticipate that, with enrollment and the additional sites, there will be certain cohorts with a specific treatment and patients with certain biomarkers to be evaluated for any type of efficacy. If we do see a signal, where a certain patient population that is biomarker enriched is benefitting with treatment, then those cohorts will expand into the next phase. It is our hope to find a drug and a biomarker that may benefit a patient population currently out there.
Q: What cancer types are the focus of the trial?
A: In general, the trial is inclusive of most solid tumors, as well as lymphoma and multiple myeloma. Numerous treatments have been supplied by partners in the pharmaceutical industry. These are all FDA–approved treatments and they are paired with biomarkers specified in the protocol. This is truly a collaborative effort by ASCO, industry, regulatory officials, and oncologists and providers at these various cancer sites.
Q: When do you anticipate the earliest data to become available?
A: I would assume that there will be an update at next year’s ASCO Annual Meeting regarding more in-depth details of the protocol and some potentially early results. But, the trial is designed to continue to enroll patients. We are constantly looking for additional drugs to add to the protocol, with their accompanying biomarkers to give patients a broad range of treatments for which they can potentially be eligible.
Q: How excited are you about the progress to date and the ultimate potential of the trial?
A: As chair of the steering committee, I feel very privileged to be involved with the study. The reception really has been great. I know that our providers ... have really been enthusiastic about performing broad molecular testing and using those results to find matches in the TAPUR study. I believe that any trial that can help to empower our providers, especially with the complexities of the number of biomarkers that are being tested, and give potential treatment after receiving those results for our patients is a win–win.
Q: Is there anything else that you would like to mentio n?
A: I think it is great that ASCO is leading such an effort. This is the society’s first-ever clinical trial. The enthusiasm generated around the TAPUR trial will certainly help us move forward as we try to identify patients who may benefit from therapies that we have today. – By Jennifer Southall
For more information:
Edward S. Kim, MD, can be reached at Levine Cancer Institute at Carolinas HealthCare System, 1021 Morehead Medical Drive, Charlotte, NC 28204; email: edward.kim@carolinas.org.
Disclosure: Kim reports no relevant financial disclosures.