Cited by 780HER2/EGFR in Cancer ResearchLung Cancer Treatments and MutationsCancer Genomics and Diagnostics

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HER kinase inhibition in patients with HER2- and HER3-mutant cancers

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Hyman, David M., Piha-Paul, Sarina A., Won, Helen, Rodon, Jordi, Saura, Cristina, Shapiro, Geoffrey I., Juric, Dejan, Quinn, David I., Moreno, Victor, Doger, Bernard, Mayer, Ingrid A., Boni, Valentina, Calvo, Emiliano, Loi, Sherene, Lockhart, Albert C., Erinjeri, Joseph P., Scaltriti, Maurizio, Ulaner, Gary A., Patel, Juber, Tang, Jiabin, Beer, Hannah, Selcuklu, S. Duygu, Hanrahan, Aphrothiti J., Bouvier, Nancy, Melcer, Myra, Murali, Rajmohan, Schram, Alison M., Smyth, Lillian M., Jhaveri, Komal, Li, Bob T., Drilon, Alexander, Harding, James J., Iyer, Gopa, Taylor, Barry S., Berger, Michael F., Cutler Jr, Richard E., Xu, Feng, Butturini, Anna, Eli, Lisa D., Mann, Grace, Farrell, Cynthia, Lalani, Alshad S., Bryce, Richard P., Arteaga, Carlos L., Meric-Bernstam, Funda, Baselga, José, Solit, David B.·2018·Nature

DOI 10.1038/nature25475PMC PMC5808581

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Abstract

Somatic mutations of ERBB2 and ERBB3 (which encode HER2 and HER3, respectively) are found in a wide range of cancers. Preclinical modelling suggests that a subset of these mutations lead to constitutive HER2 activation, but most remain biologically uncharacterized. Here we define the biological and therapeutic importance of known oncogenic HER2 and HER3 mutations and variants of unknown biological importance by conducting a multi-histology, genomically selected, 'basket' trial using the pan-HER kinase inhibitor neratinib (SUMMIT; clinicaltrials.gov identifier NCT01953926). Efficacy in HER2-mutant cancers varied as a function of both tumour type and mutant allele to a degree not predicted by preclinical models, with the greatest activity seen in breast, cervical and biliary cancers and with tumours that contain kinase domain missense mutations. This study demonstrates how a molecularly driven clinical trial can be used to refine our biological understanding of both characterized and new genomic alterations with potential broad applicability for advancing the paradigm of genome-driven oncology.

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Authors: Hyman, D. M., Piha-Paul, S. A., Won, H., Rodon, J., Saura, C., Shapiro, G. I., Juric, D., Quinn, D. I., Moreno, V., Doger, B., Mayer, I. A., Boni, V., Calvo, E., Loi, S., Lockhart, A. C., Erinjeri, J. P., Scaltriti, M., Ulaner, G. A., Patel, J., Tang, J., Beer, H., Selcuklu, S. D., Hanrahan, A. J., Bouvier, N., Melcer, M., Murali, R., Schram, A. M., Smyth, L. M., Jhaveri, K., Li, B. T., Drilon, A., Harding, J. J., Iyer, G., Taylor, B. S., Berger, M. F., Cutler Jr, R. E., Xu, F., Butturini, A., Eli, L. D., Mann, G., Farrell, C., Lalani, A. S., Bryce, R. P., Arteaga, C. L., Meric-Bernstam, F., Baselga, J., & Solit, D. B.
Affiliations: Memorial Sloan Kettering Cancer Center (US)
The University of Texas MD Anderson Cancer Center (US)
Vall d'Hebron Hospital Universitari (ES)
Dana-Farber Cancer Institute (US)
USC Norris Comprehensive Cancer Center (US)
Vanderbilt University (US)
Peter MacCallum Cancer Centre (AU)
Washington University in St. Louis (US)
Puma Biotechnology (United States) (US)
Corresponding author: Hyman, David M.
ORCID: Hyman, David M.
Piha-Paul, Sarina A.
Won, Helen
Rodon, Jordi
Saura, Cristina
Shapiro, Geoffrey I.
Juric, Dejan
Quinn, David I.
Mayer, Ingrid A.
Boni, Valentina
Calvo, Emiliano
Loi, Sherene
Lockhart, Albert C.
Erinjeri, Joseph P.
Scaltriti, Maurizio
Ulaner, Gary A.
Patel, Juber
Bouvier, Nancy
Murali, Rajmohan
Schram, Alison M.
Smyth, Lillian M.
Jhaveri, Komal
Li, Bob T.
Drilon, Alexander
Harding, James J.
Iyer, Gopa
Taylor, Barry S.
Berger, Michael F.
Xu, Feng
Eli, Lisa D.
Lalani, Alshad S.
Bryce, Richard P.
Arteaga, Carlos L.
Solit, David B.
Venue: Nature
Publisher: Springer Science and Business Media LLC
Published: 2018-01-31
Volume: 554
Issue: 7691
Pages: 189-194
ISSN: 0028-0836 (ISSN-L)
1476-4687
DOI: 10.1038/nature25475
PMC: PMC5808581
OpenAlex: W2785610956
Cited by: 780
References: 54
Citations by year: 2026: 40 · 2025: 64 · 2024: 89 · 2023: 99 · 2022: 113 · 2021: 103 · 2020: 113 · 2019: 86 · 2018: 69
FWCI: 34.53
Type: journal article
Language: en
Update notices: correction (2019-02-12)
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.springer.com/tdm (tdm)
Locations: Nature (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
RePEc: Research Papers in Economics (submittedVersion)
Minerva Access (University of Melbourne) (submittedVersion)
Funders: Puma Biotechnology
National Institutes of Health (UL1TR000371)
National Cancer Institute (R01CA204749, U01CA180964, R01CA080195, P50CA098131, P30CA008748, P30CA016672, T32CA009207, R25CA020449, P30CA014089)
National Center for Advancing Translational Sciences
Topics: Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Keywords: HER2 mutation, ERBB2, HER3, neratinib, basket trials, breast cancer, biliary tract cancer, cervical cancer, targeted therapy
MeSH terms: Adult, Aged, Aged, 80 and over, Alleles, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Mutation, Neoplasms, Quinolines, Cohort Studies, Treatment Outcome, Erb-b2 Receptor Tyrosine Kinases, Mutation, Missense, Receptor, ErbB-3, Protein Kinase Inhibitors, Molecular Targeted Therapy

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HER kinase inhibition in patients with HER2- and HER3-mutant cancers

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