Study
| Randomised, open-label, phase 3 trial [KRYSTAL-12] |
| Advanced NSCLC with KRASG12C mutation, previously treated with chemotherapy and immunotherapy |
| 600 mg adagrasib twice daily (n=301) vs 75 mg/m² docetaxel every 3 wks (n=152) until progression or unacceptable toxicity |
Efficacy
| ORR: 32% vs 9% (adagrasib vs. DOCEtaxel) |
| mPFS: 5.5 mos vs 3.8 mos (HR 0.58 [0.45-0.76]) |
| Median DOR: 8.3 mos vs 5.5 mos |
Safety
| Grade >=3 AE: ALT increase (8% vs Not reported), AST increase (6% vs Not reported), diarrhoea (5% vs Not reported) |
| Treatment-related deaths: 1% vs 1% |
| Dose reductions: 48% vs 24% |
| Discontinuations due to AEs: 8% vs 14% |
Lancet Oncol 2025;406:615
http://doi.org/10.1016/S1470-2045(23)00608-9
Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025
