Barcelona, Spain - September 9, 2025 – New data presented at the World Conference on Lung Cancer (WCLC) suggest a subcutaneous (SC) formulation of amivantamab, administered every four weeks (Q4W) in combination with lazertinib, shows promising efficacy and tolerability as a first-line treatment for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). Results from cohort 5 of the PALOMA-2 trial indicate high response rates and pharmacokinetic equivalence to intravenous (IV) dosing, possibly offering a more convenient treatment option.
the study, led by Scott SC, demonstrated the SC regimen yielded favorable tolerability, with a reduced incidence of administration-related reactions and low discontinuation rates. Notably, 43% of the PALOMA-2 cohort 5 population included patients with brain metastases, and while detailed intracranial efficacy results are pending, the systemic response rates are encouraging for this subgroup.Researchers acknowledge the need for longer follow-up to determine median duration of response (DOR), progression-free survival (PFS), and overall survival (OS), given the current median follow-up of 6.5 months. Ongoing monitoring for thromboembolic complications,despite prophylactic anticoagulation,is also warranted. Future analyses will assess quality-of-life outcomes, patient-reported measures of treatment convenience, and potential pharmacoeconomic benefits.
“These findings support the continued development of SC Q4W amivantamab as a convenient, effective frontline therapy for EGFR-mutated NSCLC,” Scott reported at WCLC.
The PALOMA-2 trial (NCT05498428) findings support the viability of once-monthly SC amivantamab as a patient-centered option to IV administration, aligning with broader efforts to optimize convenience and quality of life in the management of EGFR-driven NSCLC. Further research is being conducted, including the MARIPOSA trial (NCT04487080), comparing amivantamab and lazertinib combination therapy to osimertinib.
References:
- Scott SC. First-line subcutaneous amivantamab plus chemotherapy in EGFR exon 20 insertion-mutated advanced NSCLC: results from PALOMA-2. Presented at: World Conference on Lung Cancer; Barcelona, Spain; September 6-9, 2025.
- A study of amivantamab and lazertinib combination therapy versus osimertinib in locally advanced or metastatic non-small cell lung cancer (MARIPOSA). Clinicaltrials.gov. Updated August 19, 2025. Accessed September 8, 2025.
- A study of amivantamab in participants with advanced or metastatic solid tumors including epidermal growth factor receptor (EGFR)-MUTATED NON-SMALL CELL LUNG CANCER (PALOMA-2). Clinicaltrials.gov. Updated July 18, 2025. Accessed September 8, 2025.