Sotorasib

(Lumakras®)

Sotorasib

Drug updated on 9/5/2024

Dosage FormTablet (oral; 120 mg)
Drug ClassRAS GTPase family inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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Summary
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  • Lumakras (sotorasib) is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • The pooled Objective Response Rate (ORR) for KRASG12C inhibitors (sotorasib and adagrasib) in patients with KRASG12C-mutated solid tumors was 31% (95% CI, 25-37%).
  • The pooled Disease Control Rate (DCR) for KRASG12C inhibitors was 86% (95% CI, 82-89%).
  • In KRASG12C-mutated NSCLC patients with a KEAP1 co-mutation, the ORR was significantly lower (OR: 0.35, 95% CI: 0.16-0.77) compared to those with wild-type KEAP1.
  • The pooled incidence rate of grade ≥3 adverse events (AEs) for KRASG12C inhibitors in patients with KRASG12C-mutated solid tumors was 29% (95% CI, 23-36%).
  • The population included 1224 patients with KRASG12C-mutated solid tumors, with a specific focus on NSCLC patients having a KEAP1 co-mutation; this subgroup exhibited a significantly worse ORR (OR: 0.35, 95% CI: 0.16-0.77) compared to those with wild-type KEAP1, indicating a potentially inferior therapeutic outcome.

Product Monograph / Prescribing Information

Document TitleYearSource
Lumakras (sotorasib) Prescribing Information.2023Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines