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Basket Trials: Past, Present, and Future
Yonina R Murciano-Goroff1, Manik Uppal1,2, Monica Chen1
1Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Abstract:
Large-scale tumor molecular profiling has revealed that diverse cancer histologies are driven by common pathways with unifying biomarkers that can be exploited therapeutically. Disease-agnostic basket trials have been increasingly utilized to test biomarker-driven therapies across cancer types. These trials have led to drug approvals and improved the lives of patients while simultaneously advancing our understanding of cancer biology. This review focuses on the practicalities of implementing basket trials, with an emphasis on molecularly targeted trials. We examine the biologic subtleties of genomic biomarker and patient selection, discuss previous successes in drug development facilitated by basket trials, describe certain novel targets and drugs, and emphasize practical considerations for participant recruitment and study design. This review also highlights strategies for aiding patient access to basket trials. As basket trials become more common, steps to ensure equitable implementation of these studies will be critical for molecularly targeted drug development.
Insights
Disease-agnostic basket trials test targeted therapies across cancer types, accelerating drug approvals and understanding of cancer biology. Implementing these trials requires careful biomarker selection and equitable patient access for effective molecularly targeted drug development.
Area of Science:
- Oncology
- Translational Medicine
- Clinical Trial Design
Background:
- Tumor molecular profiling reveals common cancer pathways and biomarkers exploitable for therapy.
- Disease-agnostic basket trials are increasingly used to test biomarker-driven therapies across diverse histologies.
- These trials have led to drug approvals and advanced cancer biology understanding.
Purpose of the Study:
- To review the practical implementation of molecularly targeted basket trials.
- To examine biomarker and patient selection, study design, and recruitment strategies.
- To highlight methods for improving patient access to basket trials.
Main Methods:
- Review of existing literature on basket trial design and implementation.
- Analysis of successes and challenges in molecularly targeted drug development via basket trials.
- Discussion of novel targets, drugs, and practical considerations for trial execution.
Main Results:
- Basket trials facilitate drug development by targeting common molecular pathways across histologies.
- Successful implementation hinges on precise genomic biomarker and patient selection.
- Strategies for participant recruitment and equitable access are crucial for trial success.
Conclusions:
- Basket trials are effective for developing biomarker-driven therapies across cancer types.
- Careful planning regarding molecular targets, patient selection, and study logistics is essential.
- Ensuring equitable access to basket trials is critical for advancing molecularly targeted drug development.
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