Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA
Issued Date
2024-01-01
Resource Type
ISSN
09237534
eISSN
15698041
Scopus ID
2-s2.0-85197599521
Journal Title
Annals of Oncology
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Oncology (2024)
Suggested Citation
Felip E., Cho B.C., Gutiérrez V., Alip A., Besse B., Lu S., Spira A.I., Girard N., Califano R., Gadgeel S.M., Yang J.C.H., Yamamoto S., Azuma K., Kim Y.J., Lee K.H., Danchaivijitr P., Ferreira C.G., Cheng Y., Sendur M.A.N., Chang G.C., Wang C.C., Prabhash K., Shinno Y., Stroyakovskiy D., Paz-Ares L., Rodriguez-Cid J.R., Martin C., Campelo M.R.G., Hayashi H., Nguyen D., Tomasini P., Gottfried M., Dooms C., Passaro A., Schuler M., Gelatti A.C.Z., Owen S., Perdrizet K., Ou S.H.I., Curtin J.C., Zhang J., Gormley M., Sun T., Panchal A., Ennis M., Fennema E., Daksh M., Sethi S., Bauml J.M., Lee S.H. Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA. Annals of Oncology (2024). doi:10.1016/j.annonc.2024.05.541 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/99646
Title
Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA
Author(s)
Felip E.
Cho B.C.
Gutiérrez V.
Alip A.
Besse B.
Lu S.
Spira A.I.
Girard N.
Califano R.
Gadgeel S.M.
Yang J.C.H.
Yamamoto S.
Azuma K.
Kim Y.J.
Lee K.H.
Danchaivijitr P.
Ferreira C.G.
Cheng Y.
Sendur M.A.N.
Chang G.C.
Wang C.C.
Prabhash K.
Shinno Y.
Stroyakovskiy D.
Paz-Ares L.
Rodriguez-Cid J.R.
Martin C.
Campelo M.R.G.
Hayashi H.
Nguyen D.
Tomasini P.
Gottfried M.
Dooms C.
Passaro A.
Schuler M.
Gelatti A.C.Z.
Owen S.
Perdrizet K.
Ou S.H.I.
Curtin J.C.
Zhang J.
Gormley M.
Sun T.
Panchal A.
Ennis M.
Fennema E.
Daksh M.
Sethi S.
Bauml J.M.
Lee S.H.
Cho B.C.
Gutiérrez V.
Alip A.
Besse B.
Lu S.
Spira A.I.
Girard N.
Califano R.
Gadgeel S.M.
Yang J.C.H.
Yamamoto S.
Azuma K.
Kim Y.J.
Lee K.H.
Danchaivijitr P.
Ferreira C.G.
Cheng Y.
Sendur M.A.N.
Chang G.C.
Wang C.C.
Prabhash K.
Shinno Y.
Stroyakovskiy D.
Paz-Ares L.
Rodriguez-Cid J.R.
Martin C.
Campelo M.R.G.
Hayashi H.
Nguyen D.
Tomasini P.
Gottfried M.
Dooms C.
Passaro A.
Schuler M.
Gelatti A.C.Z.
Owen S.
Perdrizet K.
Ou S.H.I.
Curtin J.C.
Zhang J.
Gormley M.
Sun T.
Panchal A.
Ennis M.
Fennema E.
Daksh M.
Sethi S.
Bauml J.M.
Lee S.H.
Author's Affiliation
Siriraj Hospital
School of Medicine
Ehime University Hospital
Moscow Healthcare Department
Yonsei Cancer Hospital
Ankara Yildirim Beyazit University
Chungbuk National University Hospital
Seoul National University Bundang Hospital
Shanghai Chest Hospital
Chung Shan Medical University Hospital
National Taiwan University Hospital
Janssen Research & Development
Chang Gung Memorial Hospital
Kindai University School of Medicine
KU Leuven– University Hospital Leuven
Istituto Europeo di Oncologia
Université de Versailles Saint-Quentin-en-Yvelines
Universiti Malaya
The Christie NHS Foundation Trust
Chung Shan Medical University
Institut de Cancerologie Gustave Roussy
Centre de Recherche en Cancérologie de Marseille
Universidade da Coruña
Universitat Autònoma de Barcelona
Meir Medical Center
Samsung Medical Center, Sungkyunkwan university
Tata Memorial Hospital
National Cancer Center Hospital
Pontifícia Universidade Católica do Rio Grande do Sul
Hospital Regional Universitario Carlos Haya
UCI School of Medicine
Universitätsklinikum Essen
City of Hope National Med Center
Hospital Universitario 12 de Octubre
The University of Manchester
Kurume University School of Medicine
Oncoclinicas&CO/MedSir
Institut du thorax Curie-Montsouris
CDMX
Alexander Fleming Cancer Institute
Henry Ford Cancer Institute
Jilin Cancer Hospital
William Osler Health System
Virginia Cancer Specialists
School of Medicine
Ehime University Hospital
Moscow Healthcare Department
Yonsei Cancer Hospital
Ankara Yildirim Beyazit University
Chungbuk National University Hospital
Seoul National University Bundang Hospital
Shanghai Chest Hospital
Chung Shan Medical University Hospital
National Taiwan University Hospital
Janssen Research & Development
Chang Gung Memorial Hospital
Kindai University School of Medicine
KU Leuven– University Hospital Leuven
Istituto Europeo di Oncologia
Université de Versailles Saint-Quentin-en-Yvelines
Universiti Malaya
The Christie NHS Foundation Trust
Chung Shan Medical University
Institut de Cancerologie Gustave Roussy
Centre de Recherche en Cancérologie de Marseille
Universidade da Coruña
Universitat Autònoma de Barcelona
Meir Medical Center
Samsung Medical Center, Sungkyunkwan university
Tata Memorial Hospital
National Cancer Center Hospital
Pontifícia Universidade Católica do Rio Grande do Sul
Hospital Regional Universitario Carlos Haya
UCI School of Medicine
Universitätsklinikum Essen
City of Hope National Med Center
Hospital Universitario 12 de Octubre
The University of Manchester
Kurume University School of Medicine
Oncoclinicas&CO/MedSir
Institut du thorax Curie-Montsouris
CDMX
Alexander Fleming Cancer Institute
Henry Ford Cancer Institute
Jilin Cancer Hospital
William Osler Health System
Virginia Cancer Specialists
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Amivantamab-lazertinib significantly prolonged progression-free survival (PFS) versus osimertinib in patients with epidermal growth factor receptor (EGFR)-mutant advanced non-small-cell lung cancer [NSCLC; hazard ratio (HR) 0.70; P < 0.001], including those with a history of brain metastases (HR 0.69). Patients with TP53 co-mutations, detectable circulating tumor DNA (ctDNA), baseline liver metastases, and those without ctDNA clearance on treatment have poor prognoses. We evaluated outcomes in these high-risk subgroups. Patients and methods: This analysis included patients with treatment-naive, EGFR-mutant advanced NSCLC randomized to amivantamab-lazertinib (n = 429) or osimertinib (n = 429) in MARIPOSA. Pathogenic alterations were identified by next-generation sequencing (NGS) of baseline blood ctDNA with Guardant360 CDx. Ex19del and L858R ctDNA in blood was analyzed at baseline and cycle 3 day 1 (C3D1) with Biodesix droplet digital polymerase chain reaction (ddPCR). Results: Baseline ctDNA for NGS of pathogenic alterations was available for 636 patients (amivantamab-lazertinib, n = 320; osimertinib, n = 316). Amivantamab-lazertinib improved median PFS (mPFS) versus osimertinib for patients with TP53 co-mutations {18.2 versus 12.9 months; HR 0.65 [95% confidence interval (CI) 0.48-0.87]; P = 0.003} and for patients with wild-type TP53 [22.1 versus 19.9 months; HR 0.75 (95% CI 0.52-1.07)]. In patients with EGFR-mutant, ddPCR-detectable baseline ctDNA, amivantamab-lazertinib significantly prolonged mPFS versus osimertinib [20.3 versus 14.8 months; HR 0.68 (95% CI 0.53-0.86); P = 0.002]. Amivantamab-lazertinib significantly improved mPFS versus osimertinib in patients without ctDNA clearance at C3D1 [16.5 versus 9.1 months; HR 0.49 (95% CI 0.27-0.87); P = 0.015] and with clearance [24.0 versus 16.5 months; HR 0.64 (95% CI 0.48-0.87); P = 0.004]. Amivantamab-lazertinib significantly prolonged mPFS versus osimertinib among randomized patients with [18.2 versus 11.0 months; HR 0.58 (95% CI 0.37-0.91); P = 0.017] and without baseline liver metastases [24.0 versus 18.3 months; HR 0.74 (95% CI 0.60-0.91); P = 0.004]. Conclusions: Amivantamab-lazertinib effectively overcomes the effect of high-risk features and represents a promising new standard of care for patients with EGFR-mutant advanced NSCLC.