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. 2024 Jan:187:107444.
doi: 10.1016/j.lungcan.2023.107444. Epub 2023 Dec 15.

Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-world data from the Italian expanded access program

Francesco Passiglia  1 , Maria Lucia Reale  2 , Giuseppe Lo Russo  3 , Giulia Pasello  4 , Gabriele Minuti  5 , Alessandra Bulotta  6 , Domenico Galetta  7 , Giacomo Pelizzari  8 , Claudio Sini  9 , Emilio Bria  10 , Elisa Roca  11 , Sara Pilotto  12 , Carlo Genova  13 , Giulio Metro  14 , Fabrizio Citarella  15 , Rita Chiari  16 , Diego Cortinovis  17 , Angelo Delmonte  18 , Alessandro Russo  19 , Marcello Tiseo  20 , Giulio Cerea  21 , Annamaria Carta  22 , Vieri Scotti  23 , Tiziana Vavalà  24 , Marta Brambilla  3 , Lucio Buffoni  25 , Roberta Buosi  26 , Chiara Catania  27 , Stefania Gori  28 , Salvatore Grisanti  29 , Francesco Agustoni  30 , Edoardo Garbo  1 , Umberto Malapelle  31 , Silvia Novello  32
Affiliations
Free article

Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-world data from the Italian expanded access program

Francesco Passiglia et al. Lung Cancer. 2024 Jan.
Free article

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.

Keywords: KRASp.G12C; Non-small cell lung cancer; Sotorasib; Targeted therapy.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.