The Newest Members of CancerLinQ's Community—FDA and NCI

REAL-WORLD EVIDENCE HAS far-reaching potential to transform cancer care if we are able to appropriately gather, analyze, and learn from it. Millions of patients receive a diagnosis each year, yet most insights that drive improvements in cancer care and treatment have come from a tiny subset of the patient population. Traditionally, the cancer community has not been able to tap into 97% of this group because these individuals are not involved in standard clinical trials.¹ This system must be revolutionized.

With this in mind, the American Society of Clinical Oncology (ASCO) is leading the development of CancerLinQ, a health information technology (IT) platform designed to harness big data for a single purpose: to rapidly improve the quality of care for people with cancer. CancerLinQ powerfully aggregates and analyzes real-world cancer care data from almost any electronic record source and has the tools to evaluate quality of care in real time, offer insights from de-identified health information based on millions of data points, and visualize patients’ medical histories in novel ways—all to enable the cancer community to more effectively understand what is taking place with patients in the real-world setting.

This is an ambitious undertaking—and one that we cannot do alone. At the June 2016 ASCO Annual Meeting, we announced that CancerLinQ was up and running and rapidly expanding, with participants ranging from small private practices to some of the nation’s leading cancer centers.² As of June 2017, the rapidly expanding CancerLinQ network included a growing number of patient records amassed from more than 90 oncology practices and institutions from 40 states and the District of Columbia. This makes CancerLinQ one the largest and most robust sources of real-world evidence in oncology. Participants range from small private practices to large academic institutions, from safety net hospitals to integrated delivery networks and the nation’s leading cancer centers.

This year, our guiding theme for our ever-growing CancerLinQ database has been “CancerLinQ is community.” We have spent the past year cultivating strategic alliances and formalizing a series of collaborative initiatives that accelerate the expansion of CancerLinQ’s reach and impact across the broader healthcare community. Not only do we have a growing network of oncology practices and providers, but CancerLinQ is proud to partner with entities across the public, private, and not-for-profit sectors that care about our mission to improve care for every patient.

The power of partnership is of paramount importance to us, and our goal is to continue to convene collaborators across the oncology community. We encourage efforts that make resources more accessible so that providers can make informed and timely decisions while caring for patients. Welcoming ideas and support from all types of stakeholders, we have forward-thinking leaders and organizations joining us as change agents. Together, we are a community movement of committed, collaborative partners from across the healthcare ecosystem working to improve the quality of cancer care for every patient.

Developed by CancerLinQ LLC, the health IT platform provides ASCO members an opportunity to improve quality of care, and every collaboration represents another positive step in that direction. The idea is that each new entity furthers CancerLinQ’s capacity to improve patient care and helps us collectively accelerate outcomes that are larger and more effective than what any one of us can achieve alone.

NCI

CancerLinQ LLC recently launched its very first partnerships with federal agencies. In June 2017, a partnership was announced between CancerLinQ LLC and the National Cancer Institute (NCI)³ to bring an exchange of information between CancerLinQ-participating oncology practices and NCI’s Surveillance, Epidemiology, and End Results (SEER) program, one of the primary sources of data on cancer incidence and survival in the United States. The goal is to provide oncologists easy access to valuable population- level cancer data while strengthening the nation’s cancer surveillance efforts through a national data-sharing collaboration.

The new partnership includes 2 major phases. Initially, NCI and CancerLinQ will incorporate national SEER data on patients diagnosed with cancer into CancerLinQ’s core quality improvement and data-sharing platform. SEER is composed of 18 central cancer registries, which currently cover approximately 30% of the US population and include de-identified, population-level data on:

• Patient demographics
• Cancer diagnosis, including tumor morphology and stage at diagnosis
• First course of treatment
• Laboratory data
• Follow-up for vital status

The integrated access to SEER data in an easy-to-visualize format will allow CancerLinQ participants to view and draw comparisons between regional- and national-level SEER data and their own practice data, enhancing their ability to inform clinical care and decision making for their patients.

In a second phase, NCI and CancerLinQ will pilot a system for care providers in select geographic regions to quickly and seamlessly upload and transmit their practice data to the SEER program directly through the CancerLinQ portal. In the United States, healthcare facilities and providers who diagnose or treat patients with cancer are legally mandated by each state to report cancer case information to their respective cancer registries. This data-sharing effort holds the promise to make legally mandated cancer surveillance reporting activities more timely, efficient, and complete, while enhancing the richness of SEER databases for population-level research with longitudinal, real-world data and insights from CancerLinQ.

FDA

CancerLinQ LLC also announced a long-term partnership with the FDA⁴ to harness cancer patient information and big data analytics to examine the real-world use of emerging and newly approved cancer therapies. Real-world data from CancerLinQ will be used to expand the knowledge base about patterns of care across all cancer types and therapies, accelerate development of novel insights that could otherwise be challenging to obtain through standard research initiatives and data collection means, and inform future FDA regulatory strategy, frameworks, and decision-making processes.

Initially, the FDA and CancerLinQ project will focus on treatments for advanced melanoma, aiming to characterize the real-world experience of these patients, inform the clinical use of approved therapies, and provide data-driven guidance for future FDA regulatory review of targeted drugs and immunotherapies. The partnership will address some of the most important and talked-about advances of the last decade, including checkpoint inhibitors, the groundbreaking class of immunotherapies, and several molecularly targeted therapies. Although these treatments have collectively transformed care for advanced melanoma and extended many patients’ lives, questions remain about their use and adoption in real-world settings. For example, relatively little is known about the specific benefits and risks of immune checkpoint inhibitors in elderly patients or those with serious health problems because such patients are often excluded from participation in studies due to the strict criteria of most clinical trials.

CancerLinQ and FDA investigators will explore a variety of issues related to the use of newly approved therapies, including the optimal sequence of treatments, the impact of comorbidities on treatment tolerability and cancer outcomes, and the experience with immunotherapy combinations versus single agents. They will share their learnings with the cancer community to help guide the use of these treatments as well as inform the development of future clinical trials and other innovative approaches for the care delivery system. The FDA may also apply the findings to future drug reviews or labeling refinements.

Under this new partnership, the FDA will be able to utilize CancerLinQ LLC’s latest offering, CancerLinQ Discovery—anonymized, statistically de-identified, fit-for-purpose clinical data sets derived from the rapidly expanding CancerLinQ platform—to support hypothesis-based research. Physicians, researchers, and analysts in oncology may submit requests to the CancerLinQ Discovery Research & Publications Committee to explore insights on cancer care questions they intend to use in creating new clinical knowledge for improving patient outcomes. In November 2016, AstraZeneca joined CancerLinQ Discovery as a founding enterprise partner.⁵

FDA and NCI are also invited to participate in the CancerLinQ Oncology Leadership Council (OLC), the official body of strategic advisors comprising member representatives from CancerLinQ’s official partner organizations and advisory groups (see photo). This is the first time that a coalition of this nature has been created and convened. As we create this community of learning in cancer, these foundational partners of CancerLinQ offer us incredible thought leadership and represent the importance of a team-based approach to delivering high quality care. The OLC embodies our commitment to value via the voices and expertise of the many stakeholders that span the care continuum, all of whom impact key decision points in a patient care. The OLC includes professional medical specialty societies that are CancerLinQ LLC partners, such as the American Academy of Physician Assistants,⁶ American Society for Radiation Oncology,⁷ Cancer Informatics for Cancer Centers,⁸ College of American Pathologists,⁹ Hematology/Oncology Pharmacy Association,¹⁰ Oncology Nursing Society,¹¹ and Society of Gynecologic Oncology.¹²

In late May, CancerLinQ LLC announced a collaboration with the National Comprehensive Cancer Network (NCCN)¹³ to provide a link to the NCCN website for easy access to the NCCN Drugs & Biologics Compendium (NCCN Compendium) within CancerLinQ. For a fee, CancerLinQ participants can access the NCCN Compendium, which will provide evidence-based guidance regarding appropriate uses of drugs and biologics in patients with cancer. The compendium includes recommendations on the appropriate use of drugs and biologics to support decision making for patients with cancer that are derived from relevant NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) along with their clinical context, route of administration, recommended use, and NCCN category of evidence. In addition to NCCN Guidelines-specific indication and use, NCCN adds relevant information, such as pharmacologic class, relevant classification codes, and FDA indication, to the searchable database.

CancerLinQ, the only effort of its kind being driven by a nonprofit organization, leverages the combined expertise of more than 40,000 of the world’s leading oncologists who make up ASCO’s membership. We are humbled by the level of engagement thus far and look forward to continuing the acceleration and expansion of CancerLinQ’s community in the coming years.AUTHOR INFORMATION

Kevin Fitzpatrick is CEO, CancerLinQ LLC.

ADDRESS FOR CORRESPONDENCE

Kevin Fitzpatrick, CEO

CancerLinQ LLC

American Society of Clinical Oncology

2318 Mill Rd.

Alexandria, VA 22314

E-mail: kevin.fitzpatrick@cancerlinq.orgREFERENCES

1. JM Unger, E Cook, E Tai, et al. The role of clinical trial participation in cancer research: Barriers, evidence, and strategies [. Alexandria, VA: American Society of Clinical Oncology Educational Book, 2016; 35:185—198. http://meetinglibrary.asco.org/record/50813/edbook#fulltext. Accessed July 18, 2017.

2. ASCO’s CancerLinQ extends its reach—58 oncology practices, 750,000 patient records, 1,000 providers under contract, new partnership launch with the nation’s leading cancer informatics association [press release]. Chicago, IL: American Society of Clinical Oncology; June 5, 2016. asco.org/advocacy-policy/asco-in-action/ascos-cancerlinq-extends-its-reach-58-oncology-practices- 750000. Accessed July 11, 2017.

3. CancerLinQ and National Cancer Institute announce partnership to enhance patient care and strengthen cancer surveillance [press release]. Chicago, IL: American Society of Clinical Oncology; June 1, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-and-national-cancer-institute-announce-partnership. Accessed July 10, 2017.

4. CancerLinQ partners with FDA to study real-world use of newly approved cancer treatments [press release]. Chicago, IL: American Society of Clinical Oncology; June 1, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-partners-fda-study-real-world-use-newly-approved. Accessed July 10, 2017.

5. Newly developed CancerLinQ discovery translates big data into practical knowledge for cancer community—AstraZeneca joins CancerLinQ Discovery as founding enterprise partner [press release]. Alexandria, VA: American Society of Clinical Oncology; Nov. 30, 2016. asco.org/advocacy-policy/asco-in-action/cancerlinq-discovery-announcement-november-2016. Accessed July 11, 2017.

6. CancerLinQ LLC and the American Academy of Physicians Assistants partner to improve cancer care—CancerLinQ platform will benefit from the expertise of those in the physician assistants’ community [press release]. Alexandria, VA: American Society of Clinical Oncology; May 18, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-llc-and-american-academy-physicians- assistants. Accessed July 11, 2017.

7. CancerLinQ partners with premier radiation oncology society—partnership with American Society for Radiation Oncology expands CancerLinQ’s database and insights to include key cancer specialty [press release]. Alexandria, VA: American Society of Clinical Oncology; Feb. 22, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-partners-premier-radiation-oncology- society. Accessed July 11, 2017.

8. CancerLinQ LLC and CI4CC launch collaboration to transform cancer data [press release]. Alexandria, VA: American Society of Clinical Oncology; June 5, 2016. asco.org/advocacy-policy/asco-in-action/cancerlinq-llc-and-ci4cc-launch-collaboration-transform-cancer-data. Accessed July 11, 2017.

9. CancerLinQ LLC and the College of American Pathologists launch partnership to improve cancer knowledge base for physicians and patients—joint work on CancerLinQ is latest in series of collaborative efforts between ASCO and the leading professional society for board-certified pathologists [press release]. Alexandria, VA: American Society of Clinical Oncology; May 9, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-llc-and-college-american-pathologists-launch. Accessed July 11, 2017.

10. CancerLinQ LLC partners with pharmacy professionals—CancerLinQ now combines the expertise of oncologists, nurses, and pharmacists to improve patient care [press release]. Alexandria, VA: American Society of Clinical Oncology; March 29, 2017. asco.org/about-asco/press-center/news-releases/ cancerlinq-llc-partners-pharmacy-professionals. Accessed July 11, 2017.

11. CancerLinQ partners with Oncology Nursing Society—collaboration builds on current efforts to support CancerLinQ practices in multidisciplinary, teambased approaches to quality care [press release]. Alexandria, VA: American Society of Clinical Oncology; May 4, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-partners-oncology-nursing-society. Accessed July 11, 2017.

12. CancerLinQ LLC and Society of Gynecologic Oncology partner to improve quality in women’s oncology care—leading professional society for comprehensive management of gynecologic cancers is the latest organization to join CancerLinQ’s growing coalition [press release]. Alexandria, VA: American Society of Clinical Oncology; May 24, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-llc-and-society-gynecologic-oncology-partner. Accessed July 11, 2017.

13. CancerLinQ and NCCN collaborating to provide evidence-based, decision- making resources to physicians—new collaboration will grant CancerLinQ subscribers streamlined access to the NCCN Compendium [press release]. Alexandria, VA: American Society of Clinical Oncology; May 31, 2017. asco.org/about-asco/press-center/news-releases/cancerlinq-and-nccn-collaborating-provide-evidence-based. Accessed July 11, 2017.

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