Amivantamab in advanced non–small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations: Real‐world data from the Italian ATLAS Registry

BACKGROUND: The treatment landscape for metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) is rapidly evolving, with the development of specific targeted therapies. The bispecific antibody amivantamab is the new standard of care for this population but real-world safety and efficacy data are lacking. METHODS: This is a multicenter, retrospective, observational study conducted on advanced NSCLC patients harboring EGFRex20ins who were included within the ATLAS Italian real-world registry between January and December 2024. Clinical-pathological features, treatment effectiveness, and safety outcomes were retrospectively collected and analyzed. RESULTS: A total of 119 advanced NSCLC patients harboring EGFRex20ins mutations were included. Seventy-six (63.9%) and 24 (20.2%) received first-line platinum-based chemotherapy with or without immunotherapy, respectively. Overall 64 of 119 patients received single agent amivantamab in the subsequent lines. Treatment-related adverse events (TRAEs) of any grade and grade 3-4 were reported in 68.8% and 10.9%, respectively, including skin rash (56%, G3 9.4%), asthenia (9%), peripheral edema (8%), and infusion-related reactions (9.4%, G3 1.5%). Dose interruptions, reductions, and discontinuations due to TRAEs occurred in 20.3%, 12.5%, and 3.1% patients, respectively. The objective response rate was 37.5%, the DCR was 66.2%, the median progression-free survival (mPFS) was 9.6 months, and the median overall survival was 16.9 months under amivantamab. Among the 23 patients with brain metastasis, 13% achieved a partial intracranial (ic) response and 43.5% a stable disease. The ic mPFS was 11.6 months. CONCLUSION: This data confirms the efficacy and safety profile of amivantamab observed in the CHRYSALIS trial, showing a meaningful clinical benefit in a heavily pretreated real-world population.

Authors

Institutions

Publication Details

Journal
Cancer
Published
2026-05-29
DOI
https://doi.org/10.1002/cncr.70476
Primary Topic
Lung Cancer Treatments and Mutations
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Amivantamab in advanced non–small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations: Real‐world data from the Italian ATLAS Registry

Gabriele Minuti, Luca Toschi, Rita Chiari, Fabrizio Citarella et al.
Cancer
Lung Cancer Treatments and Mutations
article

Amivantamab in advanced non–small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations: Real‐world data from the Italian ATLAS Registry

Gabriele Minuti, Luca Toschi, Rita Chiari, Fabrizio Citarella, Gaetano Lacidogna, Silvia Catanese, Luca Tondulli, Francesco Grossi, Lucia Anna Muscarella, M Tiseo, Alessandra Bulotta, Giulia Meoni, D. Cortinovis, Chiara Bennati, Daniele Pozzessere, Maria Lucia Reale, Giacomo Pelizzari, Brigida Stanzione, Federica Biello, Matteo Ramundo, Tiziana Vavalà, Anna Bettini, Claudio Sini, Giulia Pasello, Alberto Pavan, Giulio Cerea, Concetta Sergi, Eleonora Gariazzo, Adolfo Favaretto, Hector Soto Parra, Sara Pilotto, Michele Montrone, Giuseppe Lo Russo, Francesco Passiglia, Elisa Roca, Vieri Scotti, Marco Russano, Silvia Novello, Antonello Veccia, Salvatore Grisanti, Stefania Gori, Umberto Malapelle, Alessandro Russo, Francesco Leone, Carlo Genova, Emilio Bria, Antonio Passaro, Diana Giannarelli, Maria Pagano
article en

Abstract

BACKGROUND: The treatment landscape for metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) is rapidly evolving, with the development of specific targeted therapies. The bispecific antibody amivantamab is the new standard of care for this population but real-world safety and efficacy data are lacking. METHODS: This is a multicenter, retrospective, observational study conducted on advanced NSCLC patients harboring EGFRex20ins who were included within the ATLAS Italian real-world registry between January and December 2024. Clinical-pathological features, treatment effectiveness, and safety outcomes were retrospectively collected and analyzed. RESULTS: A total of 119 advanced NSCLC patients harboring EGFRex20ins mutations were included. Seventy-six (63.9%) and 24 (20.2%) received first-line platinum-based chemotherapy with or without immunotherapy, respectively. Overall 64 of 119 patients received single agent amivantamab in the subsequent lines. Treatment-related adverse events (TRAEs) of any grade and grade 3-4 were reported in 68.8% and 10.9%, respectively, including skin rash (56%, G3 9.4%), asthenia (9%), peripheral edema (8%), and infusion-related reactions (9.4%, G3 1.5%). Dose interruptions, reductions, and discontinuations due to TRAEs occurred in 20.3%, 12.5%, and 3.1% patients, respectively. The objective response rate was 37.5%, the DCR was 66.2%, the median progression-free survival (mPFS) was 9.6 months, and the median overall survival was 16.9 months under amivantamab. Among the 23 patients with brain metastasis, 13% achieved a partial intracranial (ic) response and 43.5% a stable disease. The ic mPFS was 11.6 months. CONCLUSION: This data confirms the efficacy and safety profile of amivantamab observed in the CHRYSALIS trial, showing a meaningful clinical benefit in a heavily pretreated real-world population.

CancerVol. 132(11)
Università Cattolica del Sacro Cuore (IT), University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Parma (IT), Humanitas University (IT), University of Padua (IT), Cardinal Health (Australia) (AU), Casa Sollievo della Sofferenza (IT), Agostino Gemelli University Polyclinic (IT), University of Catania (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Santa Chiara (IT), Azienda Ospedaliera di Perugia (IT), Azienda Sanitaria Unità Locale di Reggio Emilia (IT), Ospedale di Bolzano (IT), Ospedale degli Infermi (IT), Ospedale "Santa Maria delle Croci" di Ravenna (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), AULSS 2 Marca Trevigiana (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Ospedale Sacro Cuore Don Calabria (IT), Surgical Specialties (Canada) (CA), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Ospedale Garibaldi (IT), Ospedale Papa Giovanni XXIII (IT), Casa di Cura Villa Garda (IT), Istituto Oncologico Veneto (IT), Azienda Ospedaliera San Gerardo (IT), ATS Sardegna (Italy) (IT), Azienda Sanitaria Locale di Asti (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), Ospedale Santa Maria della Misericordia di Udine (IT), Centro di Riferimento Oncologico (IT), A. O. Ordine Mauriziano di Torino (IT), Istituto Tumori Bari (IT), IRCCS Ospedale San Raffaele (IT), National Cancer Institute (MY), Ospedale Misericordia - Grosseto (IT), Campus Bio Medico University Hospital (IT), Ospedale dell' Angelo (IT), Azienda Ospedaliera Ospedale Maggiore (IT), Tumori Foundation (US), Ospedale Policlinico San Martino (IT), Ospedale degli Infermi (IT), Ospedale Vito Fazzi (IT), Ospedale San Luigi Gonzaga (IT), Ospedale di Prato Santo Stefano (IT), Azienda Usl Toscana Centro (IT), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" (IT), IRCCS Humanitas Research Hospital (IT), European Institute of Oncology (IT), University of Milano-Bicocca (IT), University of Brescia (IT), University of Genoa (IT)
Good health and well-being
Openalex Percentile: Top 5%
Lung Cancer Treatments and Mutations
DOISourceOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.