Subcutaneous Amivantamab Efficacy and Regulatory Status

Clinical Trial Evidence

The phase III PALOMA-3 study demonstrated non-inferiority of subcutaneous amivantamab compared to intravenous formulation in 418 patients with EGFR mutation-positive NSCLC, with similar pharmacokinetic properties, objective response rate, and progression-free survival 1, 2, 3
Subcutaneous administration showed significantly fewer infusion-related reactions (13% vs 66%), shorter administration time, and higher patient satisfaction compared to IV formulation 1, 2, 3

The National Comprehensive Cancer Network recommends intravenous amivantamab-vmjw for EGFR exon 20 insertion mutations in locally advanced or metastatic NSCLC after platinum-based chemotherapy 4
IV amivantamab plus carboplatin-pemetrexed is approved as first-line therapy for EGFR exon 20 insertions, with a Category 1, preferred first-line option designation 4, 5

Subcutaneous amivantamab has dramatically reduced infusion-related reactions (13% vs 66% with IV administration) and improved patient satisfaction and convenience 1, 2, 3
Exploratory overall survival data showed improvement (HR 0.62, P=0.02) with subcutaneous amivantamab 3

Patients requiring amivantamab should receive the currently approved IV formulation rather than delaying treatment, as IV amivantamab remains a Category 1, preferred first-line option for EGFR exon 20 insertions when combined with chemotherapy 4, 5