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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, June 7, 2024
Natasha B. Leighl, MD, MMSc, FRCP, FASCO, of Princess Margaret Cancer Centre, Toronto, and colleagues conducted the PALOMA-3 trial, which evaluated the EGFR tyrosine kinase inhibitor lazertinib plus either subcutaneous or intravenous administration of the bispecific antibody amivantamab-vmjw in patients with EGFR-mutated non–small cell lung cancer (NSCLC). The preliminary results, which suggest subcutaneous administration of amivantamab may yield noninferior response compared with intravenous administration, were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8505).
“Unexpectedly, duration of response, progression-free survival, and overall survival were longer in the subcutaneous arm vs intravenous, suggesting that the route of administration or formulation may affect outcome,” the authors concluded. “The safety profile was improved for subcutaneous amivantamab, with lower venous thromboembolism rates.”
This phase III trial enrolled 418 patients with refractory, EGFR-mutated, advanced NSCLC. Participants were randomly assigned 1:1 to receive oral lazertinib plus either subcutaneous (n = 206) or intravenous (n = 212) amivantamab.
At the median follow-up of 7 months, the objective response rates in the subcutaneous and intravenous arms were 30.1% and 32.5%, respectively, which met the noninferiority criteria. Of note, the median duration of response was longer with subcutaneous amivantamab compared with intravenous amivantamab (11.2 vs 8.3 months). Progression-free survival trends favored the subcutaneous arm, but the difference was not statistically significant; overall survival was significantly longer in the subcutaneous arm than in the intravenous arm (P = .017).
Infusion-related reaction rates were significantly lower in the subcutaneous arm than in the intravenous arm (13% vs 66%), and they were mostly grade 1 to 2. Most patients received prophylactic anticoagulants (81%) to prevent venous thromboembolism. The incidence of venous thromboembolism among patients who received prophylactic anticoagulants was significantly lower than those who did not (10% vs 21%), and the risk of severe bleeding was low (1%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
