July 23, 2019
Real-World Data Enables Study of ICIs in Patients Frequently Excluded from Traditional Clinical Trials
Patients with evidence of autoimmune disease are frequently excludedfrom clinical trials for new immuno-oncology drugs. An innovative research collaboration between ASCO and the FDA sought to better understand the outcomes of patients with evidence of autoimmune diseases being treated with immune checkpoint inhibitors (ICIs) in real world settings.
Concerto HealthAI collaborated in this research initiative by providing a robust, population-scale real-world dataset and analyzed treatment patterns of patients. In a series of four abstracts, researchers found that a large number of patients with a history of autoimmune disease were being treated by ICIs.
This kind of analysis helps address – and fill – important gaps in what can be learned from traditional, prospective clinical trials when it comes to the effectiveness and safety of IO agents in this sub-population of cancer patients with a history of autoimmune diseases.
The definitive oncology RWD provided by Concerto HealthAI is a set of structured, tech-enabled, deeply abstracted data products. The four abstracts, which we presented at ASCO 2019, featured 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 non-small cell lung cancer. The data includes patient characteristics, demographics and outcomes among patients with evidence of autoimmune disease.
This research provides an opportunity to better understand the real-world patient population receiving these treatments, while looking at any potential differences in outcomes among patients with evidence of pre-existing autoimmune disease.