The TRACK Study has opened to enrollment for people in the U.S. diagnosed with rare cancers, including those with cancer of unknown primary (CUP)
Open-label, non-randomized, pragmatic study to address access issues for genomic testing with remote enrollment and consent process and provide patients with information on molecular biomarkers to inform treatment recommendations
With support from Bayer and in partnership with Foundation Medicine and academic investigators, TRACK integrates an innovative service delivery model within the research study to provide biomarker testing and genomically-informed treatment decision-making resources to patients and their healthcare providers, within their own communities
TargetCancer Foundation, with support from Bayer and in partnership with Foundation Medicine, Inc. and investigators from leading academic institutions, announced the first patients enrolled in the TCF-001 TRACK (Target Rare Cancer Knowledge) Study. TRACK aims to provide individualized treatment recommendations to patients with rare cancers, defined as cancers with an incidence of six per 100,000 people per year in the U.S., informed by genomic analysis and in consultation with field-leading rare cancer clinicians and researchers. An expert virtual molecular tumor board (VMTB) will share these recommendations with patients and their healthcare providers (HCPs), ensuring the widest range of options are considered. To learn more about TRACK and how to enroll, visit www.targetcancerfoundation.org/track.
For people diagnosed with cancer, it is important that they discuss genomic testing with their HCPs. Genomic testing can identify DNA alterations, or changes, within cancer cells that determine how a tumor behaves or why it grows.1 The results of genomic testing may help HCPs match patients to approved or investigational therapies based on the specific alteration identified.
"It wasn't until years after my initial diagnosis that I learned a genomic tumor test might help identify what was driving my cancer and which therapy would be appropriate for me," said Susan, thyroid cancer patient and advisor on the TRACK Patient and Caregiver Advisory Council. "Ultimately, the testing identified an NTRK gene fusion, a rare genomic driver of multiple tumor types. I’m hopeful TRACK will enable patients like me with rare cancers to gain access to testing and make better informed decisions throughout their treatment journey."
TRACK participants’ subsequent treatments and responses will be prospectively tracked for at least one year, observing participant outcomes based on molecularly-informed treatment decisions. Through a remote consenting process, participants can fully enroll in the study from home without travelling to a clinical trial site. Beyond potentially informing treatment options, the data produced through TRACK will also contribute to the field’s understanding of genomics in rare cancers, addressing a critical unmet need where such knowledge is otherwise lacking. Studies show rare cancers generally receive less scientific consideration and financial support than trials of more common tumors.2
As a company dedicated to new and innovative approaches to treat cancer and broader access to genomic testing, Bayer’s financial support of the TRACK Study is another key initiative it has undertaken along with various laboratory and patient advocacy groups to advance patient care.
"People with rare cancers deserve better informed, individualized and targeted treatment choices, and we look forward to having these patients enrolled in TRACK," said Jim Palma, Executive Director, TargetCancer Foundation. "We are making significant strides in shifting clinical practice norms by challenging traditional methods of clinical trial enrollment and introducing virtual care into the treatment continuum, and we are grateful for Bayer’s longstanding support of these efforts."
"Those with rare cancers are especially vulnerable to reductions in research and limited access to treatments, especially during these uncertain times," said Joseph Germino, M.D., Vice President of Medical Affairs, Oncology at Bayer. "Bayer’s recent initiatives, including the support of TRACK, encourage genomic testing and subsequent tailored treatment approaches for patients to ensure optimal care."
TRACK is sponsored and managed by TargetCancer Foundation, in partnership with Foundation Medicine. In addition, the research team for TRACK includes Principal Investigator Razelle Kurzrock, M.D. (University of California San Diego), as well as co-Principal Investigators Vivek Subbiah, M.D. (University of Texas MD Anderson Cancer Center), James Cleary, M.D., Ph.D. (Dana-Farber Cancer Institute), and Roman Groisberg, M.D. (Rutgers Cancer Institute of New Jersey).
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.
About TargetCancer Foundation
TargetCancer Foundation is a patient-founded nonprofit organization dedicated to supporting rare cancer patients and researchers, based in Cambridge, MA. Since 2009, TargetCancer Foundation has fostered the development of comprehensive rare cancer research programs through long term commitments to basic research funding, the development of research tools such as cell lines, and innovative scientific meetings. In addition, TargetCancer Foundation serves patients facing the unique challenges of rare cancers through direct guidance and clinical trial navigation, as well as the development of impactful patient-focused research studies. For more information, please visit www.targetcancerfoundation.org.
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Cancer Treatment Centers of America. Advanced genomic testing. https://www.cancercenter.com/treatment-options/precision-medicine/advanced-genomic-testing. Accessed September 2020.
Miller RC. Problems in rare tumor study: A call for papers. Rare Tumors. 2010;2:e16. https://journals.sagepub.com/doi/full/10.4081/rt.2010.e16.
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