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