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ASCO makes headway to advance national cancer moonshot initiative
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ASCO members can play a key role in advancing the vision and aims of the national cancer moonshot initiative, according to representatives of society leadership.
“We are actively engaged with the vice president’s office, and our staff has met with his staff on numerous occasions to provide input,” Richard L. Schilsky, MD, FASCO, FACP, chief medical officer of ASCO, said during a press conference. “We just completed the NCI blue ribbon panel listening session. ... The discussion was engaging and brought forth interesting and provocative ideas for the panel to consider. We are in the thick of this and are certainly happy to be here.”
On June 28, ASCO submitted a letter with recommendations to the NCI blue ribbon panel for how it could best engage in the cancer moonshot initiative.
The recommendations included the need for enhanced access to clinical outcomes databases — such as ASCO’s CancerLinQ platform — to allow researchers and clinicians to learn from all patients with cancer, not just those treated on clinical trials.
ASCO also outlined the importance of having a national cancer research system.
“CancerLinQ is only one project,” the letter said. “A successful cancer moonshot will need a sustained and well-funded national cancer research system, and a clinical research infrastructure that extends beyond our current National Clinical Trials Network and brings trials to patients as they are identified at the point of care.”
Examples of trials that can benefit patients across tumor types include ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study and the NCI-Molecular Analysis for Therapy Choice trial.
“[These trials] leverage rapid advances in tumor genomic sequencing and broadening availability of such testing to facilitate participation in studies at more sites,” the letter said.
Key research areas
Limitation of financial resources remains one key challenge.
“The moonshot initiative will generate terrific ideas and a great vision for the future of cancer research,” Schilsky said. “However, an important element that is in parallel with the moonshot is President Barack Obama’s call for incremental funding for cancer research. Limited resources demand a sharp focus.”
Although the budget of NCI and NIH has increased in recent years — with a $2 billion funding increase proposed for NIH in the fiscal year 2017 — it has not kept pace with inflation. Since 2003, the purchasing power of NIH declined 18%, and NCI’s purchasing power declined 21%, according to statistics provided by One Voice Against Cancer.
In response to this deficit, the president’s budget proposal for fiscal year 2017 included $755 million in mandatory funds for new cancer-related research at NIH and the FDA.
“Eight hundred million will not make up for the multibillion-dollar shortfalls, but it will certainly help,” Schilsky said.
Several key research areas have been identified as part of the moonshot initiative. They include cancer vaccine development, pediatric cancers, early detection of cancer, genomic profiling of tumors and surrounding cells, and enhanced data sharing.
One purpose of the blue ribbon panel — composed of 28 experts in oncology — is to offer solutions for how to best invest cancer research funding within these areas.
“The time for creating evidence for change in practice to be implemented currently takes up to 17 years. I do not think any industry is as slow as we are in adopting new ideas and changes,” Deborah Mayer, PhD, RN, professor at University of North Carolina School of Nursing and director of cancer survivorship at UNC Lineberger Comprehensive Cancer Center, said during the press conference. “With the implementation of working groups, we hope to look at ways to identify and test methods to more effectively disseminate and implement information about new approaches for cancer prevention, risk assessment, screening, prognosis, treatment and survivorship through the rest of life after a cancer diagnosis.”
The blue ribbon panel’s first report will be submitted to the National Cancer Advisory Board, and its recommendations will be made public this summer.
TAPUR study
The TAPUR clinical trial — the first conducted by ASCO — is designed to identify new uses for targeted therapies outside of their FDA–approved indications.
“We know that it takes a long time to launch a clinical trial, enroll participants and obtain data,” Schilsky said. “Meanwhile, the science moves on and the impact of the clinical trial can be in many ways blunted if there are new data that come out that make the clinical trial questioned.”
Researchers involved with TAPUR are enrolling adults with advanced cancer for whom standard treatment has not been effective, has stopped working, or does not exist. Patients must have at least one genomic variation detected so they can be matched with therapy.
There are 37 clinical sites accruing patients across Michigan, North Carolina, South Carolina and Idaho. As of early June, 47 patients consented to participate and eight pharmaceutical companies had provided 17 marketed therapies.
An independent data safety monitoring board will review the outcomes to determine when the results will be released.
“Our goal is to make the study results widely available,” Schilsky said. “We have a plan in place to rapidly expand the number of sites across the country where the study will be available.
“TAPUR is a major collaborative effort, and we think it will leverage the platform for a number of different initiatives that will be informative for the moonshot initiative.” he added. “We also have a goal to extend TAPUR to pediatric cancer research, and we hope it will facilitate many of the overall goals of the cancer moonshot initiative.”
CancerLinQ
As of early June, 58 practices — representing 1,000 physicians across 39 states and Washington, D.C. — had joined CancerLinQ, ASCO’s “big-data” initiative.
“When I spoke about CancerLinQ during last year’s [ASCO Annual Meeting], I said we would hopefully have 15 practices enrolled in CancerLinQ by the time of the 2016 ASCO Annual Meeting,” Allen S. Lichter, MD, FASCO, former CEO of ASCO, said. “We now have 58 practices enrolled and we have another 200 practices in queue.”
CancerLinQ has pooled data on approximately 750,000 patient records across the United States. The data will be securely processed and analyzed to provide immediate quality feedback and personalized insights on a scope previously unattainable.
“Today, we are focused on quality improvement. Tomorrow, we are focused on empowering the oncology community through a powerful shared data ecosystem so that the future will be fueled by data,” Lichter said. “We envision a world that is powered using real-world data to fill evidence gaps in cancer research.” – by Jennifer Southall
Reference:
Hayes, DF. ASCO letter to NCI blue ribbon panel members. Available at: www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/June-2016-ASCO-Submissions-to-Cancer-Moonshot.pdf. Accessed July 13, 2016.
Disclosure: Lichter, Mayer and Schilsky report no relevant financial disclosures.