Table 1 Examples of successful biomarker-driven, tumor agnostic oncology trials

Broad programs

NCI-MATCH

Multi-arm; assigned treatment based on specific genetic changes

NCT02465060

Specific trials resulting in drug approvals

Trial(s)

Design

Drug

Biomarker

Outcome

KEYNOTE-158 (NCT02628067)

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pembrolizumab

Genetic (MSI-H, dMMR, TMB-H)^a

FDA approval 6/2020

LOXO-TRK-14001 (NCT02122913)

SCOUT (NCT02637687)

NAVIGATE (NCT02576431)

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larotrectinib

Genetic (NTRK1/2/3 alterations)

FDA approval 11/2018

STRTRK-2 (NCT02568267)

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entrectinib

Genetic (NTRK, ROS1, or ALK fusions)

FDA approval 8/2019