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
Year: 2026
Type: article
Study design: Observational Study
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.
Source: Cancer
DOI: 10.1002/cncr.70476
Authors: Francesco Passiglia, Antonio Passaro, Eleonora Gariazzo, Michele Montrone, Giulia Pasello, Marcello Tiseo, Marco Russano, Fabrizio Citarella, Lucia Anna Muscarella, Daniele Pozzessere, Emilio Bria, Elisa Roca, Giulio Cerea, Alessandro Russo, Salvatore Grisanti, Alessandra Bulotta, Antonello Veccia, Federica Biello, Giuseppe Lo Russo, Sara Pilotto, Carlo Genova, Diego Cortinovis, Gabriele Minuti, Giulia Meoni, Stefania Gori, Maria Lucia Reale, Alberto Pavan, Matteo Ramundo, Francesco Grossi, Hector Soto Parra, Vieri Scotti, Tiziana Vavalà, Claudio Sini, Concetta Sergi, Giacomo Pelizzari, Rita Chiari, Brigida Stanzione, Adolfo Favaretto, Francesco Leone, Anna Cecilia Bettini, Maria Pagano, Luca Tondulli, Luca Toschi, Gaetano Lacidogna, Chiara Bennati, Silvia Catanese, Umberto Malapelle, Diana Giannarelli, Silvia Novello
Institutions: Ospedale San Luigi Gonzaga, University of Turin, European Institute of Oncology, Azienda Ospedaliera di Perugia, Istituto Tumori Bari, University of Padua, Istituto Oncologico Veneto, University of Parma, Campus Bio Medico University Hospital, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Casa Sollievo della Sofferenza, Ospedale di Prato Santo Stefano, Azienda Usl Toscana Centro, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Ospedale P. Pederzoli – Casa di Cura Privata S.p.a., Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Humanitas University, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Brescia, IRCCS Ospedale San Raffaele, Ospedale Santa Chiara, Azienda Ospedaliero Universitaria Maggiore della Carita, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Ospedale Policlinico San Martino, University of Genoa, University of Milano-Bicocca, Instituto Nazionale Tumori Regina Elena, Nuovo Ospedale San Giovanni di Dio, Ospedale Sacro Cuore Don Calabria, Ospedale Vito Fazzi, Ospedale dell' Angelo, Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card. G. Panico", Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, Ospedale Garibaldi, Azienda sanitaria universitaria Friuli Centrale, Centro di Riferimento Oncologico, AULSS 2 Marca Trevigiana, Ospedale degli Infermi, Ospedale Papa Giovanni XXIII, Ospedale di Bolzano, IRCCS Humanitas Research Hospital, A. O. Ordine Mauriziano di Torino, Ospedale "Santa Maria delle Croci" di Ravenna, Ospedale Misericordia - Grosseto, University of Naples Federico II, Istituti di Ricovero e Cura a Carattere Scientifico
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7162859771