1116P United Kingdom real-world experience of sotorasib in KRAS G12C mutant non-small cell lung cancer: A British thoracic oncology group review

Abstract

Sotorasib has recently been licensed in Europe and USA for locally advanced and metastatic KRAS G12C mutant non-small cell lung cancer (NSCLC), following platinum chemotherapy and/or immunotherapy, based on the CodeBreaK 100 phase I/II trial. Given the small sample size and that patients in clinical trials are rarely representative of those in routine practice, it is vital to compare clinical trial data with real world experience. Under the auspices of the British Thoracic Oncology Group, retrospective data was collected on patients prescribed sotorasib as per license, including those on compassionate access schemes. Data included patient demographics, diagnostic and prior treatment information, as well as outcomes of therapy. 89 patients were treated from 22 sites across the UK. Objective response rate was 34.8% with a median progression-free survival of 185 days. The most common adverse event was diarrhoea (34%). One patient had a grade 4 event: thrombocytopenia. Comparison of efficacy and toxicity to the CodeBreak 100 trial is shown in the table.Table: 1116PCodeBreaK 100Real World DataBaseline DataN. of Patient12689Female (%)6366.1Median Age (Yrs; Range)63.5 (37 – 80)66 (42 – 88)Performance Score 0-1 (%)10071.9Median (range) previous therapies2 (1 – 3)2 (1-5)Brain Metastases (%)20.613.4Sotorasib Efficacy DataDisease Control Rate (%)80.662.9Objective Response Rate (%)37.134.8Overall Survival (Days)380 (95% CI 304 – NA)262 (95% CI 210 - NA)Progression Free Survival (days)206 (95% CI 155 – 249)185 (95% CI 171 – NA)Grade 3 and above adverse events (%)20.69Dose Reductions (%)22.219.1 Open table in a new tab Although immature, real world data matches that of the CodeBreaK 100 study, confirming sotorasib as an effective treatment for relapsed KRAS G12C mutant NSCLC. Updated response and survival data will be presented.