Sotorasib

(Lumakras®)

Lumakras®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 320 mg, 240 mg, 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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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • The pooled objective response rate (ORR) for KRAS (G12C) inhibitors, including sotorasib, was 28.6% (95 % confidence interval (CI), 21.2-36.6%), with a disease control rate (DCR) of 85.5% (95% CI, 82.2-88.6%). Sotorasib showed effectiveness in heavily pretreated patients with advanced KRAS(G12C)-mutated solid tumors.
  • Progression-free survival (PFS) at 6 and 12 months was 49.6% (95% CI, 41.4-57.9%) and 26.7% (95% CI, 19.8-34.1%), respectively. The median duration of response (DoR) was 10.54 months (95% CI, 7.72-13.36 months), indicating sustained benefit in responding patients.
  • In a specific subgroup with KRAS(G12C)-mutated non-small cell lung cancer (NSCLC) and KEAP1 co-mutation, the ORR was worse compared to patients with wild-type KEAP1 (odds ratio (OR): 0.35, 95% CI: 0.16-0.77), suggesting reduced effectiveness in this subgroup.
  • The pooled incidence of any grade treatment-related adverse events (trAEs) for sotorasib was 79.3% (95% CI, 66.2-90.0%), with 24.4% (95% CI, 16.7-32.9%) experiencing grade three or more trAEs.
  • Compared to adagrasib, sotorasib had significantly lower incidences of both any grade trAEs (OR, 0.07, 95% CI, 0.03-0.14) and grade three or more trAEs (OR, 0.34, 95% CI, 0.24-0.49).

Product Monograph / Prescribing Information

Document TitleYearSource
Lumakras (sotorasib) Prescribing Information.2024Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines