Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-world data from the Italian expanded access program
Francesco Passiglia, Maria Lucia Reale, Giuseppe Lo Russo, Giulia Pasello, Gabriele Minuti, Alessandra Bulotta, Domenico Galetta, Giacomo Pelizzari, Claudio Sini, Emilio Bria, Elisa Roca, Sara Pilotto, Carlo Genova, Giulio Metro, Fabrizio Citarella, Rita Chiari, Diego Cortinovis, Angelo Delmonte, Alessandro Russo, Marcello Tiseo, Giulio Cerea, Annamaria Carta, Vieri Scotti, Tiziana Vavalà, Marta Brambilla, L Buffoni, Roberta Buosi, Chiara Catania, Stefania Gori, Salvatore Grisanti, Francesco Agustoni, Edoardo Garbo, Umberto Malapelle, Silvia Novello
Abstract
BACKGROUND: Sotorasib showed a significant improvement of progression free survival (PFS), safety and quality of life over docetaxel in patients with KRASp.G12C-mutated advanced non-small-cell lung cancer (NSCLC) within the CodeBreak-200 study. Here we report real-world efficacy and tolerability data from NSCLC patients who received sotorasib within the Italian expanded access program (EAP). METHODS: Sotorasib (960 mg, orally, once daily) was available on physician request for KRASp.G12C mutant advanced NSCLC patients. Clinical-pathological and molecular data were collected from the Italian ATLAS real-world registry. Patients underwent CT-scan and responses were evaluated by RECIST criteria. Efficacy and tolerability outcomes have been assessed. RESULTS: A total of 196 advanced NSCLC patients were treated across 30 Italian centers. Median age was 69 years old (range 33-86). Most patients were male (61 %), former (49 %) or current smokers (43 %), with ECOG-PS 0/1 (84 %) and adenocarcinoma subtype (90 %). 45 % and 32 % of patients received sotorasib in 2nd and 3rd line, respectively. Overall, response rate was 26 % and the median duration of response was 5.7 months (95 % CI: 4.4-7.0). Median PFS and OS were 5.8 months (95 % CI: 5 - 6.5) and 8.2 months (95 % CI: 6.3 - 9.9). Grade 3-4 TRAEs occurred in 16.5 % of patients, with Grade ≥ 3 liver enzyme increase and TRAEs-related discontinuation reported in 12 % and 4.6 % of cases. CONCLUSION: Real-world data from the Italian EAP confirm the tolerability and effectiveness of sotorasib in patients with KRASp.G12C-mutated advanced NSCLC and highlight the value of the national ATLAS network as source of real-world evidence driving the clinical management of NSCLC patients.