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Sotorasib in Advanced KRAS G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients

Silvia Novello1, Natalie Maimon Rabinovich2, Jin-Yuan Shih3

  • 1Department of Oncology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy.

JTO Clinical and Research Reports
|April 20, 2026
PubMed
Abstract

Insights

Sotorasib demonstrated comparable safety and efficacy in advanced KRAS G12C-mutated NSCLC patients, even with ECOG PS 2 or CNS metastases. Real-world data showed median progression-free survival of 6.3 months and overall survival of 9.5 months.

Area of Science:

  • Oncology
  • Medical Genetics

Background:

  • Non-small cell lung cancer (NSCLC) with KRAS G12C mutation presents a therapeutic challenge.
  • Targeted therapies like sotorasib offer new treatment avenues.
  • Expanded access programs provide real-world data beyond clinical trials.

Purpose of the Study:

  • To evaluate the safety and efficacy of sotorasib in a broad patient population with advanced KRAS G12C-mutated NSCLC.
  • To assess sotorasib's outcomes in patients with specific baseline characteristics, including ECOG performance status (PS) 2 and central nervous system (CNS) metastases.

Main Methods:

  • Data collected from two global protocols (Study-436 and Study-442) under an expanded access program.
  • Descriptive statistical analysis of baseline characteristics, safety, and efficacy data.
  • Oral sotorasib administered at 960 mg daily.

Main Results:

  • 268 patients received sotorasib; 21.3% had ECOG PS 2 and 31.0% had prior CNS metastases.
  • Treatment-related adverse events occurred in 64.9% of patients, most commonly diarrhea (31.3%).
  • Median real-world progression-free survival was 6.3 months; median overall survival was 9.5 months, with similar outcomes regardless of ECOG PS or CNS metastases history.

Conclusions:

  • Sotorasib's safety and efficacy were consistent in patients with ECOG PS 2 and/or CNS metastases compared to the general study population.
  • Outcomes were comparable to those reported in pivotal clinical trials.
  • Real-world data support sotorasib's use in a broader NSCLC patient population.
Keywords:
CNS metastasesEastern Cooperative Oncology Group performance status 2 (ECOG PS 2)Expanded access program (EAP)KRAS G12C-mutated advanced non–small cell lung cancer (NSCLC)Sotorasib

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