J&J's RYBREVANT FASPRO Regimen Shows 77% Response Rate in First-Line HNSCC Study

Johnson & Johnson (JNJ) reported a confirmed overall response rate of 77%, including complete responses in 14% of patients, from Cohort 5 of the Phase 1b/2 OrigAMI-4 study of subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) combined with a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data covered patients excluding those with HPV-associated oropharyngeal squamous cell carcinoma. Tumor shrinkage occurred in all evaluable patients, and 65% of responses remained ongoing at a median follow-up of 10.6 months. J&J said the results support continued evaluation of the regimen in the pivotal Phase 3 OrigAMI-5 trial testing it as a first-line HNSCC option. The company said the findings reinforce dual targeting of EGFR and MET, pathways implicated in 80% to 90% of HNSCC cases.