Amivantamab in recurrent/metastatic head and neck squamous cell carcinoma after immune checkpoint inhibitor and chemotherapy

Barbara Burtness, MD, presents the results from cohort 1 of the phase 1b/2 OrigAMI-4 trial, evaluating subcutaneous amivantamab monotherapy in patients with p16-negative recurrent or metastatic head and neck squamous cell carcinoma previously treated with an immune checkpoint inhibitor and platinum-based chemotherapy. In 102 patients, blinded independent central review confirmed an objective response rate of 42%, including complete responses in 15% and partial responses in 27%. Investigator-assessed ORR was 47%, and 84% of evaluable patients had target-lesion shrinkage. Responses occurred rapidly, with a median time to response of 6.6 weeks, and were durable, with median duration of response not reached and 63% of responses ongoing. At 11.8 months of median follow-up, median progression-free survival was 6.8 months and median overall survival was 12.5 months. Findings support ongoing first-line investigation in recurrent or metastatic HNSCC. The safety profile was consistent with prior subcutaneous amivantamab reports, with no new safety signals identified.