Amgen Inc. — Lumykras EMA EPAR public assessment report (EMEA/H/C/005522, 2022)
Amgen Inc. · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This report details the EMA's conditional marketing authorization for Lumykras (sotorasib) as a monotherapy for previously treated adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), addressing a significant unmet medical need. Clinical efficacy from the CodeBreaK 100 study showed an objective response rate of 37.4% and a median duration of response of 11.1 months. While generally well-tolerated, adverse events, including gastrointestinal issues and elevated liver enzymes, were observed. Non-clinical assessments indicated no genotoxicity or carcinogenicity. Sotorasib exhibits complex pharmacokinetics with low absorption and extensive CYP3A4 metabolism. A confirmatory Phase 3 trial (CodeBreaK 200) comparing sotorasib to docetaxel is ongoing. Some CHMP members expressed reservations regarding the sufficiency of efficacy data from the single-arm trial.
Key findings — cited to the page
| Grade ≥3 GGT increased (NSCLC patients) | 2.6 % | · p.133 |
| Grade ≥3 Hepatotoxicity (NSCLC patients) | 15 % | · p.139 |
| Grade ≥3 hepatotoxicity adverse events (NSCLC patients) | 15 % | · p.132 |
| Grade ≥3 ALP increased (NSCLC patients) | 4.2 % | · p.133 |
| Grade ≥3 AEs (NSCLC patients) | 61 % | · p.139 |
| Grade ≥3 AEs (total any tumour type/any dose pool) | 53.3 % | · p.139 |
| Grade 5 TEAEs (NSCLC patients) | 35 cases | · p.132 |
| TEAE Grade ≥ 3 | 61 % | · p.141 |
| Grade ≥ 3 renal toxicity adverse events | 3 % | · p.132 |
| Hyponatremia (Grade ≥ 3 renal toxicity) | 2 % | · p.132 |
| Grade ≥3 Total bilirubin increased (NSCLC patients) | 1.6 % | · p.133 |
| AST increased (Grade ≥3) (NSCLC patients) | 6.5 % | · p.139 |
Source: Amgen Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →