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Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2
Brian M Alexander1, Patrick Y Wen, Lorenzo Trippa
1Department of Radiation Oncology, Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, MA, USA. bmalexander@lroc.harvard.edu
Abstract:
The traditional clinical trials infrastructure may not be ideally suited to evaluate the numerous therapeutic hypotheses that result from the increasing number of available targeted agents combined with the various methodologies to molecularly subclassify patients with glioblastoma. Additionally, results from smaller screening studies are rarely translated to successful larger confirmatory studies, potentially related to a lack of efficient control arms or the use of unvalidated surrogate endpoints. Streamlining clinical trials and providing a flexible infrastructure for biomarker development is clearly needed for patients with glioblastoma. The experience developing and implementing the I-SPY studies in breast cancer may serve as a guide to developing such trials in neuro-oncology.
Insights
Glioblastoma clinical trials need modernization to test new targeted therapies effectively. Adapting adaptive trial designs, like those used in breast cancer, could accelerate drug development for brain tumors.
Area of Science:
- Neuro-oncology
- Clinical trial design
- Translational research
Background:
- Traditional clinical trials struggle to evaluate numerous targeted agents for glioblastoma due to molecular subclassification complexities.
- Limited success in translating smaller screening studies to larger confirmatory trials suggests issues with control arms and surrogate endpoints.
Purpose of the Study:
- To highlight the need for streamlined clinical trials and flexible biomarker development infrastructure for glioblastoma.
- To propose the I-SPY adaptive trial model as a potential framework for neuro-oncology studies.
Main Methods:
- Review of challenges in current glioblastoma clinical trial infrastructure.
- Examination of the I-SPY (Platform for Early-Phase Clinical Trials) adaptive study model in breast cancer.
Main Results:
- Current infrastructure is ill-equipped for the pace of targeted glioblastoma therapies and molecular subtyping.
- Adaptive trial designs offer a more efficient model for evaluating multiple agents and biomarkers.
Conclusions:
- Glioblastoma research requires innovative clinical trial designs to accelerate therapeutic development.
- The I-SPY model provides a valuable blueprint for creating more agile and effective neuro-oncology trials.
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