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Defining precision: The precision medicine initiative trials NCI-MPACT and NCI-MATCH
Geraldine O'Sullivan Coyne1, Naoko Takebe2, Alice P Chen1
1Division of Cancer Treatment and Diagnosis, Developmental Therapeutics Clinic, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Abstract:
"Precision" trials, using rationally incorporated biomarker targets and molecularly selective anticancer agents, have become of great interest to both patients and their physicians. In the endeavor to test the cornerstone premise of precision oncotherapy, that is, determining if modulating a specific molecular aberration in a patient's tumor with a correspondingly specific therapeutic agent improves clinical outcomes, the design of clinical trials with embedded genomic characterization platforms which guide therapy are an increasing challenge. The National Cancer Institute Precision Medicine Initiative is an unprecedented large interdisciplinary collaborative effort to conceptualize and test the feasibility of trials incorporating sequencing platforms and large-scale bioinformatics processing that are not currently uniformly available to patients. National Cancer Institute-Molecular Profiling-based Assignment of Cancer Therapy and National Cancer Institute-Molecular Analysis for Therapy Choice are 2 genomic to phenotypic trials under this National Cancer Institute initiative, where treatment is selected according to predetermined genetic alterations detected using next-generation sequencing technology across a broad range of tumor types. In this article, we discuss the objectives and trial designs that have enabled the public-private partnerships required to complete the scale of both trials, as well as interim trial updates and strategic considerations that have driven data analysis and targeted therapy assignment, with the intent of elucidating further the benefits of this treatment approach for patients.
Insights
Precision cancer therapy trials are exploring if targeted treatments based on genomic alterations improve patient outcomes. These studies, like the National Cancer Institute
Area of Science:
- Oncology
- Genomics
- Clinical Trials
Background:
- Precision medicine aims to tailor cancer treatments to individual molecular profiles.
- Traditional clinical trials face challenges in integrating genomic characterization for therapy selection.
- The National Cancer Institute (NCI) Precision Medicine Initiative addresses these challenges through large-scale collaborative efforts.
Purpose of the Study:
- To evaluate the effectiveness of precision oncotherapy by matching molecular aberrations with targeted anticancer agents.
- To discuss the design and objectives of genomic-guided clinical trials within the NCI Precision Medicine Initiative.
- To present interim updates and strategic considerations for data analysis and targeted therapy assignment.
Main Methods:
- Utilizing next-generation sequencing (NGS) for comprehensive genomic profiling of tumors.
- Implementing genomic to phenotypic trials (e.g., NCI-Molecular Profiling-based Assignment of Cancer Therapy and NCI-Molecular Analysis for Therapy Choice).
- Leveraging large-scale bioinformatics processing for data analysis and treatment selection.
Main Results:
- Interim trial updates and data analysis strategies are being employed.
- Public-private partnerships have been crucial for the scale of these trials.
- The focus is on elucidating the benefits of targeted therapy assignment based on genetic alterations.
Conclusions:
- Precision cancer therapy, guided by molecular profiling, holds promise for improving clinical outcomes.
- The NCI Precision Medicine Initiative demonstrates the feasibility of large-scale genomic-guided trials.
- Continued research and strategic partnerships are essential for advancing precision oncology.