David M. Hyman
大卫·海曼
MD
Chief Medical Officer, Oncology肿瘤学首席医学官
👥Biography 个人简介
David M. Hyman, MD is Chief Medical Officer for Oncology at AstraZeneca, having previously served as Chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center. He is one of the world's foremost experts on tissue-agnostic oncology drug development and has played a central role in the clinical programs that led to the first two tissue-agnostic FDA approvals: larotrectinib and entrectinib for NTRK fusion-positive solid tumors. Hyman led LOXO-101 (larotrectinib) early-phase trials at MSKCC, demonstrating unprecedented response rates of approximately 75% across 17 tumor histologies harboring NTRK gene fusions, irrespective of tumor type. His work fundamentally redefined the regulatory paradigm for oncology drug approval, shifting the focus from histology-based indications to molecularly defined biomarker populations. He has also contributed to the clinical development of drugs targeting FGFR alterations and has published over 250 peer-reviewed articles on genomic biomarkers and targeted therapy.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
Larotrectinib and the Tissue-Agnostic NTRK Approval
Led early-phase clinical development of larotrectinib (LOXO-101) at MSKCC, demonstrating ~75% overall response rate across 17 NTRK fusion-positive tumor types regardless of histology, enabling the first histology-agnostic FDA approval based on a single molecular biomarker (NTRK gene fusions) and establishing the tissue-agnostic regulatory paradigm.
NTRK Fusion Detection: Clinical and Molecular Framework
Established clinical and molecular criteria for NTRK fusion testing across tumor types, defined the prevalence and distribution of NTRK1/2/3 fusions in different cancer histologies, and provided recommendations for integrating pan-cancer NTRK testing into comprehensive genomic profiling workflows.
FGFR Alterations as Actionable Biomarkers
Contributed clinical evidence for the actionability of FGFR1-4 alterations (fusions, mutations, amplifications) across tumor types including bladder cancer, cholangiocarcinoma, and myeloid neoplasms, informing companion diagnostic development for erdafitinib and infigratinib.
Representative Works 代表性著作
Efficacy of Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children
New England Journal of Medicine (2018)
Pivotal pooled analysis of three larotrectinib trials demonstrating 75% overall response rate across 55 patients with 17 different TRK fusion-positive cancer types, supporting FDA approval of the first tissue-agnostic targeted therapy.
AKT inhibition in solid tumors with AKT1 mutations
Journal of Clinical Oncology (2017)
Early tissue-agnostic biomarker-driven trial demonstrating clinical activity of AKT inhibitor capivasertib in AKT1 E17K-mutant solid tumors, establishing proof-of-concept for pan-tumor AKT targeting.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-01-15 | All information from publicly available academic sources
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