Study
| Type: Phase 3, international, randomized trial |
| Population: Patients with previously untreated EGFR-mutated advanced NSCLC (Ex19del or L858R) |
| Treatment: Amivantamab–lazertinib vs. osimertinib monotherapy vs. lazertinib monotherapy |
Efficacy
| ORR: Amivantamab–lazertinib 86%, Osimertinib 85% |
| DoR: Amivantamab–lazertinib 25.8 months, Osimertinib 16.8 months |
| mPFS: |
| Amivantamab–lazertinib 23.7 months (95% CI, 19.1 to 27.7) |
| Osimertinib 16.6 months (95% CI, 14.8 to 18.5) |
| Lazertinib 18.5 months (95% CI, 14.8 to 20.1) |
| mOS: Median not reached; 82% alive at 18 months, 74% at 24 months (Amivantamab–lazertinib) |
| 79% alive at 18 months, 69% at 24 months (Osimertinib) |
Safety
| Any Grade AEs: Amivantamab–lazertinib: infusion-related reactions, venous thromboembolic events; Osimertinib: paronychia, rash |
| Grade ≥3 AEs: Amivantamab–lazertinib 75%, Osimertinib 43% |
| Serious AEs: Amivantamab–lazertinib 49%, Osimertinib 33% |
| Infusion-related reactions occurred in 63% (Amivantamab–lazertinib) vs. none in Osimertinib |
| Venous thromboembolic events: 37% (Amivantamab–lazertinib) vs. 9% (Osimertinib) |
| Interstitial lung disease or pneumonitis: 3% in both groups |
| Adverse events leading to death: Amivantamab–lazertinib 8%, Osimertinib 7% |
N Engl J Med. Published June 26, 2024
Cho BC,Lu S,Felip E Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC
http://doi.org/10.1056/NEJMoa2403614
Reviewed by Ulas D. Bayraktar, MD on Aug 27, 2024
