COPERNICUS Safety Data and Pragmatic Trial Design

Estelamari Rodriguez, MD, MPH, of Sylvester Comprehensive Cancer Center describes COPERNICUS, a pragmatic study of first-line subcutaneous amivantamab plus lazertinib with protocol-directed supportive care in epidermal growth factor receptor (EGFR)-mutated advanced non–small cell lung cancer (NSCLC), which was open at her own site. She highlights a reduction in most adverse events, venous thromboembolism in 3% of participants, and administration-related reactions that were rarely seen. Matthew Gumbleton, MD, PhD, of Huntsman Cancer Institute recalls how difficult early intravenous administration was, with patients in the chair all day and repeated pages about reactions, and says that has resolved with the subcutaneous formulation and monthly dosing after the loading phase. Siddhartha Devarakonda, MD, of Providence Swedish Cancer Institute says his institution no longer stocks the intravenous formulation, and the panel values the largely US, older population studied, which Dr Rodriguez says speaks directly to the thrombotic risk she weighs in older patients already taking anticoagulation.