Alexandria, Va. — CancerLinQ LLC, a wholly-owned nonprofit subsidiary of the American Society of Clinical Oncology (ASCO), has brought on technology collaborators Concerto HealthAI and Tempus to accelerate its joint research effort with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) aimed at understanding the real-world use, tolerability, and effectiveness of immune checkpoint inhibitors. Concerto HealthAI and Tempus have begun to assist in the analysis of a de-identified data set that CancerLinQ has provided to the FDA, representing more than 10,000 patients who have been treated with immune checkpoint inhibitors for both approved and unapproved indications.

In June 2017, CancerLinQ LLC and the FDA announced a long-term partnership to explore the real-world use of emerging and newly approved therapies, including optimal sequencing of treatments, the impact of non-cancer health issues on treatment tolerability and cancer outcomes, and use of immunotherapy combinations versus single agents. 

"These types of research efforts need to span across the cancer community because one organization cannot accomplish them alone," said CancerLinQ LLC CEO Cory Wiegert. "We are excited that Concerto HealthAI and Tempus are bringing their technical capacity and analytic expertise to this important effort in support of the FDA's evaluation of these therapies outside of clinical trials." 

Through this research agreement, the collaborators will study a de-identified data set of patients who have received any of the following immune checkpoint inhibitor medications: atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi), ipilimumab (Yervoy), nivolumab (Opdivo), or pembrolizumab (Keytruda). Concerto HealthAI and Tempus are providing analytic support through their existing agreement with CancerLinQ LLC, announced late last year, in which both companies will curate CancerLinQ® data into high-quality datasets to be used to improve quality of cancer care and for research.

The FDA will then evaluate the incidence of immune-related adverse events in patients receiving these therapies. CancerLinQ® data will also enable the FDA to examine the use of immune checkpoint inhibitors in patients who are poorly represented in clinical trials, including older patients, racially diverse populations, and individuals with autoimmune diseases.

CancerLinQ and the FDA will then share their findings with the cancer community to help guide the use of these treatments and inform the development of future clinical trials. The FDA may also apply the findings to future drug reviews or labeling refinements.

CancerLinQ LLC entered into an agreement with Concerto HealthAI (formerly: Precision HealthAI Solutions) and Tempus, announced in December 2017, to accelerate the development and delivery of high-quality, de-identified clinical databases for use by CancerLinQ®, its oncologist subscribers, partners, and the broader cancer community. Through the agreement, Concerto HealthAI and Tempus are curating information into high-quality, HIPAA-compliant datasets to be used to improve quality of cancer care. These datasets will be made available through the core CancerLinQ® quality improvement platform and CancerLinQ Discovery®, a service that provides access to high-quality, de-identified datasets for non-profit organizations, health care providers, academic researchers, and government agencies.  

CancerLinQ® is supported in part through Conquer Cancer, the ASCO Foundation, whose generous donors have helped make the system possible. Major supporters include Amgen; Astellas; AstraZeneca; Bayer HealthCare Pharmaceuticals Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cancer Treatment Centers of America®; Chan Soon-Shiong Family Foundation; Genentech BioOncology™; HELSINN; Janssen Oncology; Lilly; Raj Mantena, RPh; Novartis Oncology; Pfizer Oncology; Thomas G. Roberts, Jr., MD and Susan M. DaSilva; and Susan G. Komen®.

CancerLinQ® and CancerLinQ Discovery® are projects of CancerLinQ LLC. For more information on how to participate or partner with CancerLinQ, please visit CancerLinQ.org.