The research is being presented at 2019 ASCO Annual Meeting;
Application of ConcertAI’s unique tech-enabled structured and abstracted datasets derived from ASCO’s CancerLinQ Discovery®

Boston, MA, May 30, 2020 – ConcertAI announced today that it is a first author and co-author in a series of four Real-World Evidence research abstracts on cancer patients with autoimmune disease which will be presented between June 1-3, at the 2019 ASCO Annual Meeting, in Chicago. This RWE research seeks to better understand real-world uses of immune checkpoint inhibitors (ICIs) and outcomes and effects of the current treatment landscape for this patient population which is frequently excluded from clinical trials. ConcertAI provided RWD and analysis to ASCO’s CancerLinQ to support the research collaboration between ASCO and FDA.ConcertAI provided its definitive oncology RWD — a set of structured, tech-enabled and deeply abstracted data products – for this body of research that looked at the real-world outcomes of cancer patients with autoimmune disorders who are being treated with ICIs. This RWE research will help advance clinical trial design and post-approval studies.These research abstracts demonstrate the utility of ConcertAI’s technology-enabled RWD – using machine learning, natural language-processing and machine-assisted human abstraction to create robust, rapid query datasets – for powerful RWE solutions that bring an understanding of patients to clinical researchers at a speed not possible with traditional methods.

“By combining Concerto’s analytic capabilities with FDA’s vision and CancerLinQ’s medical informatics expertise, we help address deficits in the external validity of clinical trials by revealing how ICIs have been used since their introduction in 2011 in patients with a wide variety of cancers, and show the interplay between autoimmune disease, immune-related adverse events and efficacy,” said Wendy Rubinstein, M.D., Ph.D., CancerLinQ’s Deputy Medical Director, who is a lead author on these studies and a driving force in forming this collaboration.

The four abstracts feature a retrospective observational analysis of a de-identified CancerLinQ Discovery® dataset of more than 12,000 patients who have been treated with ICIs and a subset of patients with advanced NSCLC. The analysis details patient characteristics, demographics and outcomes among patients stratified by autoimmune disease status; these patients are excluded from prospective randomized controlled trials. The data provide an opportunity to better understand the real-world patient population receiving these treatments as well as analyze any potential variances in outcomes among patients with a pre-existing autoimmune disease.

“Examination of treatment patterns with real world data found that a large number of patients treated with new immuno-oncology agents had a history of autoimmune disease,” said Edward Stepanski, Ph.D., a co-author on all four abstracts and Chief Operating Officer of Concerto

HealthAI’s Outcomes Science group. “We are able to evaluate the effectiveness and safety of these IO agents in this sub-population and fill a gap in what has been learned from prospective clinical trials.”

“The significance of this research to clinical researchers, regulators and patients cannot be understated,” said Jeff Elton, Ph.D. and CEO of ConcertAI. “As the study of cancer becomes more specialized, clinically-validated, highly-precise RWE insights are becoming ever more necessary. ConcertAI is honored to be a part of this research effort with CancerLinQ and bring our highly precise, rapid-query RWD to bear on RWE research that will ultimately improve outcomes by getting patients into the right clinical trials and by bringing more effective therapies to market faster.”

Abstract and Session Details:

1. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs)

Clinical Science Symposium
Track: Using Real-World Data to Advance Research and Care
First Author: Sean Khozin, MD, MPH; The U.S. Food and Drug Administration
Date/Time: June 3, 10:33-10:45AM
Location: McCormick Place, Hall D1
Abstract: #110

2. Characteristics of patients receiving immune checkpoint inhibitors (ICI) in ASCO’s CancerLinQ

Poster Session, Poster Board #210
Track: Developmental Immunotherapy and Tumor Immunobiology
First Author: Wendy S. Rubinstein, MD, PHD; ASCO CancerLinQ
Date/Time: Sat, June 1, 8:00 AM – 11:00 AM
Location: McCormick Place, Hall A
Abstract: #2566

3. Real-world prevalence of autoimmune disease (AD) among patients receiving immune checkpoint inhibitors (ICI) in ASCO’s CancerLinQ database.

Poster Session, Poster Board #274
Track: Health Services Research, Clinical Informatics, and Quality of Care
First Author: Li Chen; ConcertAI
Date/Time: Sat, June 1, 1:15 PM – 4:15 PM
Location: McCormick Place, Hall A
Abstract: #6583

4. Real-world characteristics and outcomes of patients with advanced non-small cell lung cancer (aNSCLC) receiving immune checkpoint inhibitor.

Poster Session, Poster Board #433
Track: Lung Cancer—Non-Small Cell Metastatic
First Author: Sean Khozin, MD, MPH; FDA
Date/Time: Sun, Jun 2, 8:00 AM – 11:00 AM
Location: McCormick Place, Hall A
Abstract: #9110