Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 200 mg) |
| Drug Class | RAS GTPase family inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- As a single agent, indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cance (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
- In combination with cetuximab, indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecanbased chemotherapy.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The pooled Objective Response Rate (ORR) for Kirsten Rat Sarcoma (KRAS)(G12C) inhibitors was 28.6% (95% confidence interval (CI), 21.2-36.6%) and 31% (95% CI, 25-37%).
- The pooled Disease Control Rate (DCR) was 85.5% (95% CI, 82.2-88.6%) and 86% (95% CI, 82-89%).
- The Progression-Free Survival (PFS) rate at 6 months was 49.6% (95% CI, 41.4-57.9%) and at 12 months, 26.7% (95% CI, 19.8-34.1%).
- The pooled analysis of treatment-related adverse events (trAEs) showed an incidence of 79.3% (95% CI, 66.2-90.0%) for any grade trAEs, with 24.4% (95% CI, 16.7-32.9%) of patients experiencing grade three or more trAEs.
- Sotorasib was associated with significantly lower incidences of any grade trAEs (odds ratio (OR) = 0.07, 95% CI, 0.03-0.14) and grade three or more trAEs (OR = 0.34, 95% CI, 0.24-0.49) compared to adagrasib.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Krazati (adagrasib) Prescribing Information. | 2024 | Bristol-Myers Squibb Company, Princeton, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and toxicity of KRAS(G12C) inhibitors in advanced solid tumors: a meta-analysis | 2024 | World Journal of Surgical Oncology |
| Outcomes following KRAS(G12C) inhibitor treatment in patients with KRAS(G12C)-mutated solid tumors: A systematic review and meta-analysis | 2024 | Pharmacological Research |