On June 3, 2022 Medidata, a Dassault Systèmes company, reported that new research on predicting cytokine release syndrome (CRS) resulting from longitudinal CAR T-cell therapy (CAR T) at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7 in Chicago (Press release, Medidata, JUN 3, 2022, View Source [SID1234615534]).
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"CAR T therapy has been a significant innovation in cancer care – but as with any new and complex therapy, it has brought its own challenges and problems to solve. CRS – a life-threatening toxic immune reaction to CAR T therapy – has been seen in a meaningful number of patients and has led to at least 15 clinical trial failures for new therapies since 2016," said Jacob Aptekar, MD, vice president at Medidata. "Many known physiological markers that could indicate risk for severe CRS are difficult to measure but the study presented at ASCO (Free ASCO Whitepaper) is an important step in demonstrating how commonly collected laboratory tests – like a complete blood count (CBC) – can be used to assess CRS risk in a large number of patients across multiple clinical trials, indications, and CAR T products."
Titled "Predictors of severe CRS in longitudinal CAR T-cell clinical trial data," the study used the company’s Medidata Acorn AI platform to analyze 542 patients pooled from multiple clinical trials. These are significantly more patients than previous CRS studies, which have traditionally used a limited number of patients from a single clinical trial or clinical site. The Medidata study demonstrated notable differences in commonly measured biomarkers including platelet counts, serum albumin concentration, creatinine levels, and neutrophil counts between patients who experience severe CRS versus those who do not.
The Medidata study includes a conclusion that a Risk Evaluation and Mitigation Strategy for CRS may be warranted for CAR T therapy, both during clinical trials and in real-world use, using periodic monitoring of common lab markers to assess the risk level and enable early intervention when warranted.
"The trend across oncology is towards precision treatment and research. This Medidata study is a critical piece of that puzzle for CAR T therapy, empowering both researchers and health care providers to better understand the safety and efficacy of treatments in specific patients," said Michael Kattan, PhD, the Dr. Keyhan and Dr. Jafar Mobasseri Endowed Chair for Innovations in Cancer Research and chairman, Department of Quantitative Health Sciences at the Cleveland Clinic. "By understanding where the warning signs for CRS are, we can design safer trials, avoid and better understand trial failures, and get better and safer innovative treatments to more patients in more care settings."
Medidata Acorn AI leverages the company’s rich, regulatory grade clinical data, machine learning and AI capabilities, and pharmaceutical product development expertise to drive value for the life sciences community. Built upon the Medidata platform, comprising more than 28,000 trials and more than eight million patients and healthy volunteers across 140-plus countries, Acorn AI solutions feature the industry’s largest structured, standardized clinical trial data repository connected with real-world, translational, and other datasets.
To learn more about this study and about Medidata Acorn AI, please visit Medidata’s booth (#3037) or visit its show website.
Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.