AE Profile and Discontinuation Rate in Cohort 1

Paul L. Swiecicki, MD, of the University of Michigan Rogel Cancer Center, characterizes the safety and tolerability of subcutaneous amivantamab monotherapy in cohort 1 of the OrigAMI-4 study. He reports that the profile was consistent with prior studies of subcutaneous amivantamab in lung and colorectal cancer, with no new toxicity signals in this head and neck squamous cell carcinoma (HNSCC) population. Severe adverse events occurred in 39% of patients, with the most common treatment-related events being hypoalbuminemia, rash, and acneiform dermatitis with paronychia, most grade 1 or 2; only 8% of patients discontinued treatment because of an adverse event. Unlike intravenous amivantamab, which has a history of infusion-related reactions, Dr. Swiecicki notes that the subcutaneous formulation produced only mild administration-related reactions. He adds that COCOON prophylaxis, which has improved rash and dermatitis tolerability in lung cancer, was not yet available during cohort 1, and speculates that the 37% rash incidence seen here might have been lower had it been used.