RARITAN, N.J., February 19, 2026 – Johnson &. Johnson (NYSE:JNJ) today announced promising new data from the Phase 1b/2 OrigAMI-4 study demonstrating that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with pembrolizumab delivers clinically meaningful and durable antitumor activity in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is PD-L1-positive and human papillomavirus (HPV)-unrelated.
The data, presented during a plenary session at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS), showed a confirmed overall response rate of 56 percent (22/39; 95 percent confidence interval [CI], 40-72) among patients receiving the combination therapy. This included six complete responses and 18 partial responses, all confirmed, representing a 10 percent complete response rate. At a median follow-up of 10.4 months, 46 percent of patients remained on treatment, and tumor shrinkage was observed in 82 percent of patients.
Head and neck squamous cell carcinoma is an aggressive disease, and current first-line treatment options offer limited benefit. PD-1 monotherapy historically achieves response rates of approximately 18 percent, with only modest improvements seen when combined with chemotherapy, leaving many patients without substantial clinical benefit, according to the company.
“From a clinical perspective, rapid and durable disease control is an important goal in the first-line treatment of head and neck cancer,” said Ranee Mehra, M.D., Director of Head and Neck Medical Oncology and Professor of Medicine at the Marlene and Stewart Greenebaum Comprehensive Cancer Center at the University of Maryland. “Combining subcutaneous amivantamab with immunotherapy is promising because it targets key drivers of tumor growth and resistance, which is resulting in deeper responses compared with current standards.”
The clinical benefit rate, defined as confirmed response or durable stable disease, was 74 percent (29/39; 95 percent CI, 58-87). Responses occurred rapidly, with a median time to first response of 9.7 weeks, and treatment was ongoing in 64 percent of confirmed responders at the time of data cutoff. Median progression-free survival was 7.7 months (95 percent CI, 5.0-not estimable), and the median overall survival was not yet estimable.
The safety profile of the combination was consistent with those of the individual agents, with no new safety signals identified. The most common treatment-emergent adverse events, occurring in more than 30 percent of patients, were rash (49 percent), paronychia (46 percent), hypoalbuminemia (41 percent), dermatitis acneiform (38 percent), increased aspartate aminotransferase (38 percent), increased alanine aminotransferase (36 percent), and stomatitis (36 percent). Administration-related reactions occurred in 15 percent of patients, with none being Grade 3 or higher. Four patients discontinued treatment due to treatment-related adverse events.
Joshua Bauml, M.D., Vice President, Lung and Head and Neck Cancer Disease Area Leader, Johnson & Johnson, stated, “Seeing rapid and durable disease control at levels meaningfully higher than what has historically been achieved signals the potential to redefine what treatment can offer patients.”
The study included five cohorts evaluating amivantamab across different treatment settings and regimens. Cohort 1 evaluated amivantamab as monotherapy in patients with HPV-unrelated R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Cohort 2, the focus of today’s announcement, is evaluating amivantamab in combination with pembrolizumab in patients with HPV-unrelated R/M HNSCC who have not yet received treatment for their advanced disease and whose tumors express PD-L1.
Johnson & Johnson is continuing to evaluate RYBREVANT FASPRO™-based regimens in HNSCC, including the ongoing Phase 3 OrigAMI-5 study (NCT07276399) assessing subcutaneous amivantamab with carboplatin and pembrolizumab as a first-line treatment in patients with HPV-unrelated R/M disease, regardless of PD-L1 expression.
