Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 120 mg) |
| Drug Class | RAS GTPase family inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Sotorasib (Lumakras) is a specific, irreversible inhibitor of the GTPase protein, KRASG12C.
- Two randomized controlled trials were reviewed that focused on the use of sotorasib for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.
- The first trial compared sotorasib to docetaxel in previously treated NSCLC patients and found that it significantly increased progression-free survival from 4.75 months to 5.76 months and had fewer grade 3 or worse treatment-related adverse events than docetaxel.
- In terms of safety profile, common severe side effects associated with sotorasib included diarrhea, increase in alanine aminotransferase levels and aspartate aminotransferase levels while those associated with docetaxel included neutropenia, fatigue and febrile neutropenia.
- The second trial was single-group phase-2 study which showed an objective response rate of 37% among enrolled participants majority of whom had previously received both platinum-based chemotherapy and inhibitors programmed death ligand-1(PD-L1).
- Subgroup analysis revealed responses across different subgroups defined according to PD-L1 expression level, tumor mutational burden, and co-occurring mutations in STK11, KEAP1, or TP53 genes suggesting potential effectiveness irrespective these factors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lumakras (sotorasib) Prescribing Information. | 2023 | Amgen Inc., Thousand Oaks, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. | Data not availableSubjects F: null% M: null% | 2023 | Lancet |
| Sotorasib for lung cancers with KRAS p.G12C mutation. | 126Subjects F: 50% M: 50% | 2021 | The New England Journal of Medicine |
Sex Distribution:
Year:
2023
Source:Lancet
Document Title
Sex Distribution:
F:50%
M:50%
126Subjects
Year:
2021
Source:The New England Journal of Medicine
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Canadian Consensus Recommendations on the Management of KRAS G12C-Mutated NSCLC. | 2023 | Current Oncology |