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| IMI PRECISE4Q | |
|---|---|
| Name | PRECISE4Q |
| Sponsor | Innovative Medicines Initiative |
| Phase | Observational/Interventional |
| Status | Completed |
| Start date | 2021 |
| Completion date | 2024 |
IMI PRECISE4Q IMI PRECISE4Q was a multinational clinical research initiative that evaluated precision oncology strategies across solid tumors, integrating biomarkers, imaging, and digital health tools. The project convened stakeholders from pharmaceutical industry leaders, academic centers, regulatory agencies, and patient advocacy groups to harmonize protocols and accelerate translational research.
The program was initiated under the aegis of the Innovative Medicines Initiative and drew expertise from partners including the European Commission, European Medicines Agency, and national research institutes like Institut Pasteur, Karolinska Institutet, and University College London to address challenges exemplified by earlier consortia such as The Cancer Genome Atlas, International Cancer Genome Consortium, and the Precision Medicine Initiative. Core objectives were to validate predictive biomarkers, standardize next-generation sequencing workflows, and evaluate integrated care pathways informed by precedents set by the National Institutes of Health, Wellcome Trust, and Fondation ARC. The effort aimed to align methodological standards used by the European Organisation for Research and Treatment of Cancer, American Society of Clinical Oncology, and the National Comprehensive Cancer Network while engaging regulatory science discussions involving the Food and Drug Administration and European Commission.
PRECISE4Q employed a multi-arm, adaptive platform design drawing on statistical frameworks from the I-SPY trials, Basket trial methodologies used in SHIVA, and umbrella trial concepts exemplified by Lung-MAP and NCI-MATCH. Central laboratories coordinated molecular profiling using protocols referenced by the College of American Pathologists, European Society for Medical Oncology, and Association for Molecular Pathology. Imaging harmonization followed standards from the Radiological Society of North America, European Society of Radiology, and Quantitative Imaging Biomarkers Alliance, while digital endpoints leveraged platforms developed by Roche, Novartis, AstraZeneca, and academic partners such as MIT and ETH Zurich. Data governance referenced FAIR principles promoted by CERN, EMBL-EBI, and the Global Alliance for Genomics and Health, with statistical oversight informed by guidance from the International Committee of Medical Journal Editors and CONSORT.
Enrollment targeted adults with advanced solid tumors, recruiting across comprehensive cancer centers such as Institut Curie, Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, and Gustave Roussy, with trial sites spanning countries represented by Charité – Universitätsmedizin Berlin, University of Amsterdam, and Hospital Clínic de Barcelona. Inclusion and exclusion criteria were aligned with prior oncology studies by the European Organisation for Research and Treatment of Cancer, Dana-Farber Cancer Institute, and Royal Marsden Hospital to ensure comparability to cohorts in studies like KEYNOTE, CheckMate, and IMpassion trials. Patient consent workflows involved advocacy groups including Cancer Research UK, American Cancer Society, and European Cancer Patient Coalition.
Treatment arms combined targeted therapies sourced from industry partners such as Pfizer, Merck, GlaxoSmithKline, and Bristol Myers Squibb with companion diagnostics developed alongside Illumina, Thermo Fisher Scientific, and Roche Diagnostics. Arms included kinase inhibitors, immune checkpoint inhibitors, and combination regimens inspired by trials from Janssen, Bayer, and Eli Lilly, while some cohorts received biomarker-directed off-label therapies following approaches used by ASCO TAPUR. Ancillary interventions included radiologic response assessment protocols from SNMMI and cooperative group supportive care standards from EORTC and SWOG.
Primary endpoints included objective response rate and progression-free survival as defined by RECIST criteria used by the European Medicines Agency and FDA oncology guidance, while secondary endpoints encompassed overall survival, quality-of-life measures using instruments validated by the European Organisation for Research and Treatment of Cancer and the Patient-Reported Outcomes Measurement Information System, and biomarker concordance metrics benchmarked against standards from the International Organization for Standardization and Clinical Laboratory Improvement Amendments. Exploratory endpoints assessed circulating tumor DNA dynamics with methods harmonized to protocols from the Broad Institute, Sanger Institute, and Fred Hutchinson Cancer Research Center.
PRECISE4Q reported that biomarker-driven allocation improved objective response rates in selected cohorts, corroborating signals observed in NCI-MATCH and I-SPY trials, with concordant ctDNA dynamics predicting outcomes in analyses analogous to studies by Dana-Farber, Memorial Sloan Kettering, and University of Texas MD Anderson. Imaging biomarker harmonization reduced inter-site variability comparable to results from the Quantitative Imaging Network and Radiological Society of North America initiatives. Subgroup analyses showed differential benefit for actionable alterations identified by assays from Illumina and Thermo Fisher, aligning with regulatory observations from the European Medicines Agency and FDA. Safety profiles mirrored class effects reported in pivotal trials from Pfizer, Merck, and Bristol Myers Squibb.
The consortium influenced guideline discussions at European Society for Medical Oncology, American Society of Clinical Oncology, and national health technology assessment bodies such as NICE and IQWiG by providing evidence for scalable precision oncology workflows. Implementation activities included technology transfer to regional cancer centers including Institut Curie, Gustave Roussy, and Charité, and policy dialogues involving the European Commission, World Health Organization, and OECD on data sharing and evidence standards. Future directions proposed integration with national genomic initiatives like Genomics England, All of Us Research Program, and Genome Canada, expanded public–private partnerships involving Wellcome Trust and Gates Foundation, and prospective confirmatory trials coordinated with cooperative groups such as EORTC, SWOG, and ECOG-ACRIN.
Category:Clinical trials