ASCO Expands TAPUR Sites; Inks Collaborations to Investigate Precision Oncology Globally
Posted: Tuesday, June 06, 2017
ASCO Expands TAPUR Sites; Inks Collaborations to Investigate Precision Oncology Globally
CHICAGO (GenomeWeb) – The American Society of Clinical Oncology has expanded the Targeted Agent and Profiling Utilization Registry (TAPUR) study to around 100 sites in the US, and inked collaborations that will also bolster other countries' ability to explore precision oncology hypotheses.
At the ASCO annual meeting here yesterday, the oncology group said that as of May 31, more than 300 patients had enrolled in TAPUR ― a non-randomized basket study investigating the safety and efficacy of commercially available cancer drugs when they are given off label and based on the genomic characteristics of patients' tumors.
When the study launched over a year ago, TAPUR was enrolling patients into 35 sites. But in the coming months eight new centers at 36 locations will begin to recruit patients, increasing the number of study sites to more than 100 in 20 US states. These sites will offer patients the chance to enroll in study arms investigating 15 targeted treatment options that seven drug companies have provided.
As part of its strategy to expand recruitment efforts, ASCO lowered the eligibility age from 18 years down to 12 years, so that adolescent patients with advanced cancer could join the study. Additionally, ASCO partnered with the Canadian Cancer Trials Group and the WIN Consortium, which are developing studies based on the TAPUR basket design. ASCO, WIN, and CCTG will share study results to improve understanding of genomically defined treatment strategies.
So far, TAPUR has matched 60 percent to 65 percent of patients to treatment arms, ASCO Chief Medical Officer Richard Schilsky said.
Basket trials have found it difficult to match patients to treatment arms. For example, the NCI-MATCH trial had to go on a hiatus last year because the interest in the study far outpaced the number of patients that matched to the 10 treatment arms that were initially available. The study reopened on May 31, 2016 with 24 treatment arms, and still there is a wide gap between the number of patients getting genetically tested and the proportion of patients getting on a matching treatment.
As of April 30, out of 4,800 patients who had genetic testing with NCI-MATCH, around 860 patients had a gene abnormality matching available therapy, and around 580 patients enrolled in a treatment arm. The study organizers estimate that 72 percent of patients assigned to a treatment arm ultimately enroll.
Some of the challenge is due to the state and complexity of the science, and some experts believe that matching rates within basket studies will improve as researchers identify more targetable alterations. Access to targeted treatments and the ability to standardize genomic testing are two other factors that have challenged basket studies to date, and Cure-One, an organization previously called MED-C, is hoping to help TAPUR with the latter.
“Two of TAPUR's largest challenges were getting patient[s] access to molecular testing and not being able to standardize the testing,” according to Cure-One CEO Dane Dickson, and this has raised questions about how variability in testing would impact the ability to interpret the effectiveness of the precision oncology approach on patient outcomes.
Cure-One runs the so-called N1 Registry, which aims to provide patients access to quality NGS testing, collects data that can improve understanding of genetic markers in cancer, and tracks how genetic testing is being used in the real world and impacting patient outcomes. The organization has partnered with ASCO to help enroll patients into TAPUR through its registry.
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WIN History -
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Diversity of Stakeholders - WIN Members -
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Sharing information to promote use of personalized, targeted cancer therapy: WIN Symposia
WIN was created to accelerate the pace and reduce the cost of translating novel cancer treatments to the bedside by developing and applying, through worldwide clinical trials and research projects, the most promising advances in genomic-based cancer research. WIN aims to initiate research projects each year in a global consortium guided by an independent scientific advisory board.
WIN now includes 39 institutional members. These stakeholders have come together from all parts of the world to address the challenge of increasing the efficacy of cancer diagnostics and therapeutics by understanding the genetics and biology of each individual’s tumor and accounting for genetic differences across diverse populations—from North and South America, Europe, Asia, Middle East and Australia.
Our goal is to significantly improve outcomes for patients around the globe. We aim to increase the number of patients worldwide that have access to innovative, global clinical trials in the area of genomic-based cancer therapeutics. Global diversity and inclusion of all stakeholders is WIN’s most important and differentiating asset.
Our members include leading academic, life science, not-for-profit, health, patient advocacy and IT organizations.