(Press-News.org) (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.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.
END
PALOMA-2 study: Subcutaneous amivantamab every 4 weeks plus lazertinib shows high response rate in EGFR-mutated NSCLC
2025-09-09
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