New Drug: Lazertinib for EGFR mutated NSCLC

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

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)

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%

Cho BC,Lu S,Felip E Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC

Reviewed by Ulas D. Bayraktar, MD on Aug 27, 2024

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