Clinical trial design in the era of precision medicine

E Fountzilas, AM Tsimberidou, HH Vo, R Kurzrock - Genome medicine, 2022 - Springer
Recent rapid biotechnological breakthroughs have led to the identification of complex and
unique molecular features that drive malignancies. Precision medicine has exploited next …

The emerging clinical relevance of genomics in cancer medicine

MF Berger, ER Mardis - Nature reviews Clinical oncology, 2018 - nature.com
The combination of next-generation sequencing and advanced computational data analysis
approaches has revolutionized our understanding of the genomic underpinnings of cancer …

Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors

CA Milbury, J Creeden, WK Yip, DL Smith, V Pattani… - PLoS …, 2022 - journals.plos.org
FoundationOne® CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-
approved companion diagnostic test to identify patients who may benefit from treatment in …

Molecular profiling of cancer patients enables personalized combination therapy: the I-PREDICT study

JK Sicklick, S Kato, R Okamura, M Schwaederle… - Nature medicine, 2019 - nature.com
Cancer treatments have evolved from indiscriminate cytotoxic agents to selective genome-
and immune-targeted drugs that have transformed the outcomes of some malignancies …

Real-world data from a molecular tumor board demonstrates improved outcomes with a precision N-of-One strategy

S Kato, KH Kim, HJ Lim, A Boichard… - Nature …, 2020 - nature.com
Next-generation sequencing (NGS) can identify novel cancer targets. However, interpreting
the molecular findings and accessing drugs/clinical trials is challenging. Furthermore, many …

Tumor mutational burden as an independent predictor of response to immunotherapy in diverse cancers

AM Goodman, S Kato, L Bazhenova, SP Patel… - Molecular cancer …, 2017 - AACR
Immunotherapy induces durable responses in a subset of patients with cancer. High tumor
mutational burden (TMB) may be a response biomarker for PD-1/PD-L1 blockade in tumors …

Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial

J Rodon, JC Soria, R Berger, WH Miller, E Rubin… - Nature medicine, 2019 - nature.com
Precision medicine focuses on DNA abnormalities, but not all tumors have tractable
genomic alterations. The WINTHER trial (NCT01856296) navigated patients to therapy on …

Assessment of clinical benefit of integrative genomic profiling in advanced solid tumors

EF Cobain, YM Wu, P Vats, R Chugh, F Worden… - JAMA …, 2021 - jamanetwork.com
Importance Use of next-generation sequencing (NGS) to identify clinically actionable
genomic targets has been incorporated into routine clinical practice in the management of …

Analysis of NTRK Alterations in Pan-Cancer Adult and Pediatric Malignancies: Implications for NTRK-Targeted Therapeutics

R Okamura, A Boichard, S Kato, JK Sicklick… - JCO precision …, 2018 - ascopubs.org
Purpose Fusions that involve neurotrophic-tropomyosin receptor kinase (NTRK) genes are
known drivers of oncogenesis. Therapies that target these ultra-rare, constitutionally active …

[HTML][HTML] Whole-genome and transcriptome analysis enhances precision cancer treatment options

E Pleasance, A Bohm, LM Williamson, JMT Nelson… - Annals of …, 2022 - Elsevier
Background Recent advances are enabling delivery of precision genomic medicine to
cancer clinics. While the majority of approaches profile panels of selected genes or hotspot …