Network for Biomarker Immunoprofiling for Cancer Immunotherapy: Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC)
Helen X. Chen, Minkyung Song, Holden T. Maecker, Sacha Gnjatic, David R. Patton, J. Jack Lee, Stacey J. Adam, Radim Moravec, Xiaole Shirley Liu, Ethan Cerami, James Lindsay, Ming Tang, F. Stephen Hodi, Catherine J. Wu, Ignacio I. Wistuba, Gheath Alatrash, Chantale Bernatchez, Sean C. Bendall, Stephen M. Hewitt, Elad Sharon, Howard Streicher, Rebecca A. Enos, Melissa Bowman, Valérie Tatard-Leitman, Beatriz Sánchez‐Espiridión, Srinika Ranasinghe, Mina Pichavant, Diane M. Del Valle, Joyce E. Yu, Sylvie Janssens, Jenny Peterson-Klaus, Cathy Rowe, Gerold Bongers, Robert R. Jenq, Chia‐Chi Chang, Jeffrey S. Abrams, Margaret Mooney, James H. Doroshow, Lyndsay N. Harris, Magdalena Thurin
Abstract
PURPOSE: Immunoprofiling to identify biomarkers and integration with clinical trial outcomes are critical to improving immunotherapy approaches for patients with cancer. However, the translational potential of individual studies is often limited by small sample size of trials and the complexity of immuno-oncology biomarkers. Variability in assay performance further limits comparison and interpretation of data across studies and laboratories. EXPERIMENTAL DESIGN: Initiative of the National Cancer Institute (NCI) and the Partnership for Accelerating Cancer Therapies (PACT) with industry partners via the Foundation for the NIH. RESULTS: The CIMAC-CIDC Network is composed of four academic centers with multidisciplinary expertise in cancer immunotherapy that perform validated and harmonized assays for immunoprofiling and conduct correlative analyses. A data coordinating center (CIDC) provides the computational expertise and informatics platforms for the storage, integration, and analysis of biomarker and clinical data. CONCLUSIONS: This overview highlights strategies for assay harmonization to enable cross-trial and cross-site data analysis and describes key elements for establishing a network to enhance immuno-oncology biomarker development. These include an operational infrastructure, validation and harmonization of core immunoprofiling assays, platforms for data ingestion and integration, and access to specimens from clinical trials. Published in the same volume are reports of harmonization for core analyses: whole-exome sequencing, RNA sequencing, cytometry by time of flight, and IHC/immunofluorescence.