WCLC 2025 - Posters & ePosters-P3.12.13 Long-Term Real-World Outcomes of Sotorasib in Second-Line and Beyond Treatment of KRAS G12C-Mutated Advanced NSCLC

P3.12.13 Long-Term Real-World Outcomes of Sotorasib in Second-Line and Beyond Treatment of KRAS G12C-Mutated Advanced NSCLC

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This real-world study evaluates long-term outcomes of sotorasib, a first-in-class KRAS G12C inhibitor, in patients with previously treated advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. Sotorasib is approved for second-line (2L) and beyond treatment in this population. The analysis included data from 461 patients who initiated sotorasib between May 28, 2021, and September 30, 2023, drawn from the Flatiron Health Enhanced Datamart. Of these, 210 received sotorasib as second-line therapy, and 338 received it as second-line or later.<br /><br />Patients had a mean age of approximately 68 years, with roughly 57% female and over 70% white. Most had non-squamous histology and a history of smoking. Nearly 25% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or higher, indicating some with poor baseline function. Prior treatments commonly included anti-PD-(L)1 agents and chemotherapy, often combined in the same line of therapy.<br /><br />The primary endpoint was overall survival (OS) from the start of sotorasib treatment. Median OS was similar across 2L and 2L+ groups and aligned with outcomes from pivotal CodeBreaK 1003 and 2004 clinical trials and prior retrospective studies. Specifically, median OS ranged around 10.2 months, demonstrating durable survival benefits in a real-world setting over up to 28 months of follow-up, even in patients with poorer ECOG PS.<br /><br />These results support sotorasib’s clinical efficacy for KRAS G12C-mutated advanced NSCLC beyond clinical trials and highlight the need for further research to explore survival differences by patient subgroups, such as PD-L1 expression levels and functional status. The study was funded by Amgen Inc., and findings contribute valuable, longer-term real-world evidence supporting sotorasib’s role in advanced NSCLC management.

Asset Subtitle

Enriqueta Felip

Meta Tag

Speaker Enriqueta Felip

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

sotorasib

KRAS G12C inhibitor

non-small cell lung cancer

NSCLC

second-line therapy

overall survival

real-world study

ECOG performance status

anti-PD-(L)1 agents

advanced cancer treatment