(Barcelona, Spain--September 9, 2025 at 11:30 AM CEST / UTC +2)— A new analysis from the PALOMA-2 study presented today shows that subcutaneous administration of amivantamab every four weeks (Q4W), in combination with daily oral lazertinib, yields a high objective response rate in patients with previously untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC).
The results were presented at the International Association for the Study of Lung Cancer at the 2025 World Conference on Lung Cancer (WCLC).
In the fully enrolled Cohort 5 of the PALOMA-2 trial, the Q4W dosing regimen was shown to maintain similar efficacy compared to historical intravenous (IV) and Q2W subcutaneous data, while offering fewer administration-related reactions and improved convenience for patients.
"Subcutaneous amivantamab dosed once a month offers a less burdensome treatment option without compromising efficacy," said Dr. Susan Scott, from The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. "These data support the potential for Q4W administration to enhance quality of life for patients with EGFR-mutant NSCLC."
Dr. Scott and her colleagues enrolled 77 treatment-naïve participants with EGFR Ex19del or L858R mutations. Median age was 63 years; 68% of participants were female, and 62% were Asian. Brain metastases were present in 43% of participants at screening.
She reported the following results from the study:
- Objective response rate (ORR): 82% by investigator, 87% by independent central review (ICR).
- Confirmed ORR: 79% by investigator, 83% by ICR.
- Median time to response: 8.1 weeks.
- Median duration of response, PFS, and overall survival were not yet reached at 6.5 months follow-up.
Most adverse events were related to EGFR/MET inhibition, including paronychia, rash, and hypoalbuminemia. Administration-related reactions (ARRs) occurred in only 12% of participants, with just one Grade ≥3 ARR reported. Venous thromboembolic events (VTEs) were reported in 13% of participants, though none were Grade ≥3, and bleeding events were rare (1%).
No new safety signals were identified. Only 8% of patients discontinued amivantamab due to treatment-related adverse events. The mean plasma concentration levels were consistent with historical IV and Q2W subcutaneous dosing data, supporting pharmacokinetic equivalency.
"These findings support the continued development of subcutaneous Q4W amivantamab as a convenient, effective frontline therapy for EGFR-mutated NSCLC," Dr. Scott reported.
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