Drug updated on 9/5/2024
Dosage Form | Tablet (oral; 120 mg) |
Drug Class | RAS 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
- 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 Title | Year | Source |
---|---|---|
Lumakras (sotorasib) Prescribing Information. | 2023 | Amgen Inc., Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Outcomes following KRASG12C inhibitor treatment in patients with KRASG12C-mutated solid tumors: a systematic review and meta-analysis. | 2024 | Pharmacological Research |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Canadian Consensus Recommendations on the Management of KRAS G12C-Mutated NSCLC. | 2023 | Current Oncology |