Johnson & Johnson Announces Data From Phase 1b/2 OrigAMI-4 Trial Of Investigational Subcutaneous Amivantamab, Hyaluronidase-lpuj In Combination With PD-1 Inhibitor Shows 56% Overall Response Rate; Consistent Safety Profile

Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 1b/2 OrigAMI-4 study showing that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with a PD-1 inhibitor delivered clinically meaningful and durable antitumor activity in patients with head and neck squamous cell carcinoma (HNSCC) that is recurrent or metastatic, PD-L1-positive, and human papillomavirus (HPV)-unrelated. Data were presented during a plenary session at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) (Abstract #2).

Head and neck squamous cell carcinoma is an aggressive disease, and many patients see their cancer return or spread after their initial diagnosis. In the first-line recurrent or metastatic setting, outcomes remain poor with current standard of care. PD-1 monotherapy has historically achieved response rates of approximately 18 percent, and only modest improvements are seen when chemotherapy is added, leaving many patients without meaningful benefit.2,3 This underscores the need for approaches that address additional drivers of disease including epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), which contribute to tumor growth and treatment resistance.4,5,6 Data from lung cancer, where these same pathways have been well characterized, suggest that targeting both may change disease biology and improve outcomes.