دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Felip E; Medical Oncology Service, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: efelip@vhio.net., Cho BC; Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Gutiérrez V; Medical Oncology Department, Hospital Regional Universitario de Málaga y Virgen de la Victoria, IBIMA, Málaga, Spain., Alip A; Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia., Besse B; Paris-Saclay University, Gustave Roussy, Villejuif, France., Lu S; Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China., Spira AI; Virginia Cancer Specialists, Fairfax, VA, USA., Girard N; Institut du Thorax Curie-Montsouris, Paris, France; Paris Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France., Califano R; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, The University of Manchester, Manchester, UK., Gadgeel SM; Department of Internal Medicine, Henry Ford Cancer Institute, Detroit, MI, USA., Yang JC; National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan., Yamamoto S; Ehime University Hospital, Toon, Ehime., Azuma K; Kurume University School of Medicine, Kurume, Japan., Kim YJ; Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea., Lee KH; Medical Department, Chungbuk National University Hospital, Cheongju, Republic of Korea., Danchaivijitr P; Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand., Ferreira CG; Oncoclinicas&CO/MedSir, Rio de Janeiro, Brazil., Cheng Y; Jilin Cancer Hospital, Changchun, China., Sendur MAN; Department of Medical Oncology, Ankara Bilkent City Hospital and Ankara Yıldırım Beyazıt University, Ankara, Turkey., Chang GC; School of Medicine and Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan; Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan., Wang CC; Division of Pulmonary & Critical Care Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan., Prabhash K; Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India., Shinno Y; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan., Stroyakovskiy D; Healthcare Department, Moscow City Oncology Hospital No. 62, Moscow, Russia., Paz-Ares L; CNIO-H120 Lung Cancer Unit, University Hospital 12 de Octubre, Universidad Complutense de Madrid and CIBERONC, Madrid, Spain., Rodriguez-Cid JR; Médica Sur, Ciudad de México, CDMX, Mexico., Martin C; Thoracic Oncology Unit and Clinical Research Unit, Department of Medical Oncology, Alexander Fleming Cancer Institute, Buenos Aires, Argentina., Campelo MRG; Medical Oncology, Hospital Universitario A Coruña, A Coruña, Spain., Hayashi H; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan., Nguyen D; City of Hope National Medical Center, Duarte, CA, USA., Tomasini P; Aix Marseille University, APHM, INSERM, NCRS, CRCM, Hôpital de la Timone, Multidisciplinary Oncology & Therapeutic Innovations Department, Marseille, France., Gottfried M; Meir Medical Center, Kfar-Sava, Israel., Dooms C; Respiratory Oncology Unit, University Hospitals Leuven, Leuven, Belgium., Passaro A; Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan, Italy., Schuler M; West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen, Germany., Gelatti ACZ; Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS, Porto Alegre-RS, Brazil., Owen S; Department of Oncology, McGill University, Montréal, QC, Canada., Perdrizet K; William Osler Health System, Brampton, ON, Canada., Ou SI; Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA, USA., Curtin JC; Janssen Research & Development, Spring House, PA, USA., Zhang J; Janssen Research & Development, Spring House, PA, USA., Gormley M; Janssen Research & Development, Spring House, PA, USA., Sun T; Janssen Research & Development, Raritan, NJ, USA., Panchal A; Janssen Research & Development, High Wycombe, UK., Ennis M; Janssen Research & Development, Spring House, PA, USA., Fennema E; Janssen Research & Development, San Diego, CA, USA., Daksh M; Janssen Research & Development, Raritan, NJ, USA., Sethi S; Janssen Research & Development, Spring House, PA, USA., Bauml JM; Janssen Research & Development, Spring House, PA, USA., Lee SH; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. |
| المصدر: | Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2024 Jun 26. Date of Electronic Publication: 2024 Jun 26. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : London : Elsevier Original Publication: Dordrecht ; Boston : Kluwer Academic Publishers, c1990- |
| مستخلص: | 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. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: NSCLC; TP53; amivantamab; biomarkers; ctDNA; lazertinib |
| تواريخ الأحداث: | Date Created: 20240628 Latest Revision: 20240628 |
| رمز التحديث: | 20240629 |
| DOI: | 10.1016/j.annonc.2024.05.541 |
| PMID: | 38942080 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1569-8041 |
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| DOI: | 10.1016/j.annonc.2024.05.541 |