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Real-world Experience with Sotorasib in KRAS G12C-Mutated Advanced Non-small Cell Lung Cancer: Clinical Outcomes and
Aim:
Sotorasib is an oral, potent, selective inhibitor. It is approved for the treatment of patients with KRAS G12C mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). Real-world safety and efficacy data are essential to understand the clinical potential of sotorasib.
Materials And Methods:
Retrospective real-world evidence (RWE) was collected for UK patients with KRAS G12C mutation positive, locally advanced or metastatic NSCLC who had received sotorasib (n = 150) at 20 hospitals. Demographics, histopathology stage, PD-L1 status, metastatic disease including central nervous system (CNS) disease, Eastern Cooperative Oncology Group scale (ECOG) performance status (PS), and toxicity markers were reviewed. Progression free survival (PFS), overall survival (OS), and response rates were calculated.
Results:
Patients were aged 41-93 years (median age: 68 years; 15/150 were >80 years); 21% had an ECOG PS of 2. Most (79%) were former smokers. Ninety-eight percent had adenocarcinoma, and 83% had metastatic disease. UK RWE was compared with data from the open-label, phase 3 sotorasib trial (CodeBreaK 200). In the UK RWE, the median rwPFS was 7.0 months (95% confidence interval [CI]: 5.76-8.30); in CodeBreaK 200, median PFS was 5.6 months (95% CI: 4.3-7.8). The median real-world overall survival (rwOS) in the UK RWE was 9.54 months (95% CI: 8.47-10.60) versus 10.6 months (95% CI 8.9-10.4) for mOS in CodeBreaK 200. Treatment cessation due to AEs occurred in 20/131 UK patients (15.3%) versus 16/169 (10%) in CodeBreaK 200.
Conclusion:
The shorter median rwOS and higher rate of treatment cessation may reflect the higher proportion of older and frail patients in the UK RWE dataset compared with CodeBreaK 200. The UK RWE aligns with the results of CodeBreaK 200.