Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-word data from the Italian Expanded Access Program
Menée en Italie à partir de données portant sur 196 patients atteints d'un cancer du poumon présentant la mutation p.G12C au niveau du gène KRAS (âge médian : 69 ans), cette étude évalue l'efficacité, du point de vue du taux de réponse, de la durée de la réponse, de la survie sans progression et de la survie globale, et la toxicité du sotorasib en deuxième ou troisième ligne
Background: Sotorasib showed a significant improvement of progression free survival (PFS), safety and quality of life over docetaxel in patients with KRAS p.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 KRAS p.G12C mutant advanced NSCLC patients. Clinical-pathological and molecular data were collected from the Italian ATLAS real-word 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 G≥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 KRAS p.G12C-mutated advanced NSCLC and highlight the value of the national ATLAS network as source of real-word evidence driving the clinical management of NSCLC patients.
Lung Cancer 2023