Lumykras
Oncology· 397 cited findings· 1 source document
Company: Amgen Inc. →
What the regulatory reviews say
Lumykras is indicated as monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have progressed after at least one prior line of systemic therapy. The application for marketing authorisation was submitted on 18 December 2020, with a positive opinion from the CHMP on 11 November 2021. The conditional marketing authorisation is due by 31 March 2023.
In NSCLC, the objective response rate (ORR) for Lumykras was 37.4% (95% CI: 28.6, 46.3%). This included a complete response rate of 2.4% and a partial response rate of 34.7%. The PFS probability at 12 months in NSCLC was 16.3%. For comparison, the benchmark ORR for NSCLC was 23%, and for ramucirumab plus docetaxel in NSCLC, the ORR was 23% (95% CI: 20, 26%). The Go criterion probability for ORR > 0.23 for NSCLC was 80%.
Regarding safety, systemic exposure (AUC) relative to the human dose (960 mg) was 3.9 times higher. A notable safety finding was AST (serum transaminases) in 20% of patients. The recommended phase 2 dose (RP2D) was 960 mg QD.
Key figures — cited to the source page
| ORR in NSCLC | 37.4 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.74 |
| 95% CI for ORR in NSCLC | 28.6, 46.3 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.74 |
| PFS probability at 12 months in NSCLC | 16.3 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.77 |
| Benchmark ORR (NSCLC) | 23 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.62 |
| ORR (ramucirumab plus docetaxel in NSCLC) | 23 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.62 |
| Systemic exposure (AUC) relative to human dose (960 mg) | 3.9 times higher | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.30 |
| AST (serum transaminases) | 20 % | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.142 |
| CHMP positive opinion for marketing authorisation | 11 November 2021 | Amgen Inc. — Lumykras EMA EPAR public assessment report (EME, p.9 |
Source documents
Explore the full evidence
All 397 cited findings for Lumykras — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.