2024 World Conference on Lung Cancer (WCLC) - Posters-P3.12E.04 Long-Term Outcomes with Sotorasib in KRAS G12c-Mutated Advanced NSCLC from the Global Expanded Access Program (EAP) Study-436

P3.12E.04 Long-Term Outcomes with Sotorasib in KRAS G12c-Mutated Advanced NSCLC from the Global Expanded Access Program (EAP) Study-436

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The study detailed the long-term outcomes of sotorasib in treating KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC), a first-in-class selective inhibitor, from the Expanded Access Program (EAP) under Study-436. Including 150 patients across six countries, the study observed those typically excluded from clinical trials, such as individuals with poor prognostic indicators like ECOG PS 2 and brain metastases.<br /><br />Key findings over more than two years of follow-up showed a median real-world progression-free survival (rwPFS) of 6.3 months and a median overall survival (OS) of 9.5 months. The Kaplan-Meier estimated 1-year OS stood at 41.9%, while 2-year OS was 27.1%. Subgroup analysis revealed consistent efficacy in patients with CNS metastases and varying baseline health statuses.<br /><br />Safety data showed that 64.7% of patients experienced treatment-related adverse events (TRAEs), predominantly Grade 1 or 2, with a discontinuation rate of 6.7% due to TRAEs, primarily linked to gastrointestinal issues and elevated transaminases. Despite the diverse patient population, the safety profile aligned with previous clinical trial findings.<br /><br />The study concluded that sotorasib demonstrated efficacy across various challenging patient subgroups, maintaining a safety profile similar to controlled clinical settings. Notably, over a quarter of the patients were alive after two years, showcasing its potential as a sustainable treatment option for this hard-to-treat population.<br /><br />This investigation was supported by Amgen Inc. and acknowledged important contributions from patients, their families, and clinical teams, reflecting broadly on trials outside traditional constraints and emphasizing sotorasib's role in real-world cancer treatment efficacy.

Asset Subtitle

Silvia Novello

Meta Tag

Speaker Silvia Novello

Topic Metastatic NSCLC – Targeted Therapy

Keywords

sotorasib

KRAS G12C

non-small cell lung cancer

NSCLC

Expanded Access Program

Study-436

real-world outcomes

treatment-related adverse events

Kaplan-Meier survival

Amgen Inc.