New Drug: SubQ Amivantamab with Lazertinib for EGFR-Mutated NSCLC

In the PALOMA-3 study, subcutaneous amivantamab-lazertinib showed noninferior efficacy to intravenous administration with improved safety and convenience. The subcutaneous route significantly reduced infusion-related reactions and demonstrated a superior overall survival. Subcutaneous administration also reduced venous thromboembolism rates.

Study

Randomized, open-label, phase III trial [PALOMA-3]

Patients with EGFR-mutated advanced NSCLC progressed after osimertinib and platinum-based chemotherapy

Subcutaneous amivantamab+lazertinib (n=206) vs Intravenous amivantamab+lazertinib (n=212)

Efficacy

ORR: 30% vs 33% (subQ vs. IV) (Non-inferior)

mPFS: 6.1 mos vs 4.3 mos

12-mo OS: 65% vs. 51% (HR 0.62 [0.42-0.92])

Safety

Grade >=3 AE: dermatitis acneiform (9% vs 6%), lymphopenia (<1% vs 8%)

Infusion-related reactions: 13% vs 66% (subQ vs. IV)

Venous thromboembolism: 9% vs 14%

J Clin Oncol 2024;42:3593-3605

Leighl NB, Akamatsu H, Lim SM Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor Mutated Non Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study

http://doi.org/10.1200/JCO.24.01001

Reviewed by Ulas D. Bayraktar, MD on Jan 18, 2026

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