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Project Data Sphere Leads Unique Meeting of Regulators, Industry and Academia to Address Adverse Events for Serious Complications of New Cancer Therapies

June 6, 2018

CARY, N.C.--(BUSINESS WIRE)--Jun 6, 2018--, an independent, not-for-profit initiative of the CEO Roundtable on Cancer, Inc.’s Life Sciences Consortium, announced the first in a series of publications addressing the emerging concern of myocarditis associated with immune checkpoint inhibitor (ICI) cancer treatments.

Published in and co-authored by leading cardiologists and oncologists, the manuscript incorporates expert input from key stakeholders from academia, industry, and regulatory agencies who seek to minimize the risk of myocarditis, a potentially fatal inflammation of the heart muscle in cancer patients treated with ICIs (a class of drugs that trigger the patient’s immune system to recognize and combat cancer cells).

In December 2017, Project Data Sphere coordinated a multidisciplinary ICI-associated myocarditis workshop. This Checkpoint Inhibitor Safety Working Group included leading clinicians, academic researchers, pharmaceutical companies and regulatory agencies, including the U.S. and Chinese Food and Drug Administrations and the European Medicines Agency. The Group shared information, identified knowledge gaps, posed research questions to increase awareness, defined patients who may be at risk, and developed approaches for early diagnosis and effective treatment.

“ICIs hold great promise for extending the lives of patients with cancer,” said Martin Murphy, DMedSc, PhD, chief executive officer for Project Data Sphere, LLC. “However, rare but serious adverse events, like myocarditis, represent risk that is currently difficult to mitigate. By bringing together industry, regulators and clinicians for this face-to-face workshop, Project Data Sphere created a unique opportunity to advance our understanding, diagnosis and subsequent treatment of ICI-associated myocarditis.”

Tomas G. Neilan, MD, MPH, Associate Professor of Medicine, Harvard Medical School, Director, Cardio-Oncology Program, Division of Cardiology, Department of Medicine, Massachusetts General Hospital, and lead author of the paper commented, “Given Project Data Sphere ’s record of success accumulating datasets from traditionally competitive research organizations to pool knowledge and leverage big data for patient benefit, the organization was uniquely positioned to bring this group together. Assembling these global clinical, regulatory and industry experts to reach a consensus and sharing the available data will lead to improved care, especially for those patients that may be at risk for myocarditis.”

The impact of ICI-associated myocarditis is expected to grow as the use of ICI’s in real-world and additional clinical trial settings increases. In 2015, an estimated 600,000 patients with metastatic cancer in the United States were eligible for ICI treatment. 1 This number is anticipated to increase across all cancer types; in 2017, there were 940 immuno-oncology agents being tested in 3,042 clinical trials with a target enrollment of 577,076 patients. 2

The research to more thoroughly understand, accurately diagnose and effectively treat ICI-associated myocarditis is expected to be supported by a single, integrated database of de-identified, patient-level data within the Project Data Sphere cancer research platform. Industry sponsors, National Cancer Trial Network organizations and high-volume cancer centers will contribute to the repository.

As an open-access, data sharing platform, Project Data Sphere provides researchers with a venue to analyze large clinical datasets of ICI-treated patients that could provide a more accurate estimate of the true incidence of ICI-associated myocarditis, define its clinical characteristics, identify risk factors, and refine diagnostic and treatment algorithms. Future efforts could expand this framework to include ICI-associated myocarditis events observed in patients in the real-world setting, as well as other ICI-related rare but serious adverse events.

A free digital library-data laboratory, the Project Data Sphere cancer research platform ( www.ProjectDataSphere.org ) was launched in April 2014. The platform has grown to include patient-level data representing more than 121,000 clinical trial cancer patients. The registered user community has increased to more than 1,900 authorized users who have performed more than 11,000 downloads of data for research purposes for various cancer tumor types including bladder, breast, colorectal, gastric, kidney, lung, melanoma, pancreatic and prostate.

About Project Data Sphere, LLC

is an independent, not-for-profit initiative of the CEO Roundtable on Cancer Inc.’s Life Sciences Consortium. The , Inc. is a 501(c)(3) nonprofit corporation founded by President George H.W. Bush in 2001 to develop and implement initiatives that reduce the risk of cancer, enable early diagnosis, facilitate access to the best available treatments, and hasten the discovery of novel and more effective anti-cancer therapies. For more information, visit ProjectDataSphere.org, or follow the Project Data Sphere initiative on Twitter @ProjDataSphere.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180606006041/en/

CONTACT: Project Data Sphere, LLC

John Bluth

john.bluth@ProjectDataSphere.org

+1 650 799 6612

or

Cary Conway

cary@conwaycommunication.com

+1 972.649.4707

KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA

INDUSTRY KEYWORD: TECHNOLOGY DATA MANAGEMENT SOFTWARE HEALTH BIOTECHNOLOGY CARDIOLOGY ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Project Data Sphere, LLC

Copyright Business Wire 2018.

PUB: 06/06/2018 12:08 PM/DISC: 06/06/2018 12:08 PM

http://www.businesswire.com/news/home/20180606006041/en

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