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

Area of Science:

• Oncology
• Medical Oncology
• Pharmacology

Background:

• The CodeBreak-200 study demonstrated sotorasib's efficacy over docetaxel in KRAS G12C-mutated advanced NSCLC.
• Real-world data are crucial for understanding treatment outcomes in diverse patient populations.

Purpose of the Study:

• To evaluate the real-world efficacy and tolerability of sotorasib in KRAS G12C-mutated advanced NSCLC patients.
• To assess the utility of the Italian ATLAS real-world registry for generating evidence in NSCLC management.

Main Methods:

• Sotorasib (960 mg orally once daily) was administered to KRAS G12C-mutated advanced NSCLC patients.
• Data were collected from the Italian ATLAS real-world registry, including clinical, pathological, and molecular information.
• Tumor response was assessed using RECIST criteria via CT scans.

Main Results:

• 196 patients were treated across 30 Italian centers; median age was 69 years.
• Overall response rate was 26%, with a median duration of response of 5.7 months.
• Median progression-free survival (PFS) was 5.8 months, and median overall survival (OS) was 8.2 months. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 16.5% of patients.

Conclusions:

• Real-world data confirm sotorasib's tolerability and effectiveness in KRAS G12C-mutated advanced NSCLC.
• The Italian ATLAS network serves as a valuable source of real-world evidence for clinical management.
• These findings support the use of sotorasib in this patient population.