Durability of PFS and OS Benefit vs. Historical Control

Paul L. Swiecicki, MD, of the University of Michigan Rogel Cancer Center, discusses what the durability data from OrigAMI-4 cohort 1 suggest about subcutaneous amivantamab's benefit in recurrent or metastatic head and neck squamous cell carcinoma. He describes a median progression-free survival (PFS) of 6.8 months as exciting against a historical control of approximately 2 months and a median overall survival (OS) of 12.5 months against an expected historical benchmark of roughly 4 months. Dr Swiecicki notes that some patients had ongoing responses out to 22 months, with the tail of the Kaplan-Meier curve for duration of response still ongoing at data cutoff. He observes that the 12-month OS rate approaches what is typically seen in first-line metastatic HNSCC, which he describes as paradigm shifting for a heavily pretreated, post-checkpoint-inhibitor population and a signal of genuine clinical activity for amivantamab in this setting.