RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) combination demonstrates 77% overall response rate in first-line treatment of patients with advanced head and neck cancer
Key Highlights
- ➤77% confirmed response rate in first-line non-HPV-associated HNSCC
- ➤14% complete responses reported among 22 non-HPV-associated HNSCC patients
- ➤65% of responses remained ongoing at 10.6-month median follow-up
- ➤Phase 3 OrigAMI-5 study continues evaluating the investigational regimen
- ➤FDA Priority Review underway for later-line RYBREVANT FASPRO in head and neck cancer
Expert Statements
Paul Swiecicki, M.D., Associate Professor of Hematology/Oncology, University of Michigan Rogel Cancer Center
“The first treatment a patient receives for recurrent or metastatic head and neck cancer can shape everything that follows”
Paul Swiecicki, M.D., Associate Professor of Hematology/Oncology, University of Michigan Rogel Cancer Center
“The responses seen with subcutaneous amivantamab give us reason to think differently about what may be possible from the start of treatment, especially as we see responses across the majority of patients with head and neck cancer, excluding HPV-associated oropharyngeal squamous cell carcinoma, many of which are rapid, deep and persist over time.”
Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson
“We've already seen what subcutaneous amivantamab may offer patients with head and neck cancer after their disease has progressed. Now, we see the potential impact of using this approach earlier in recurrent or metastatic disease”
Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson
“Our experience with RYBREVANT FASPRO in lung cancer has helped establish the potential of dual EGFR/MET targeting, and these results support continued evaluation of this approach in head and neck cancer.”
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) combination demonstrates 77% overall response rate in first-line treatment of patients with advanced head and neck cancer PR Newswire
* Responses were deep and durable, with 65% ongoing at clinical cutoff * Results support continued evaluation of the investigational RYBREVANT FASPRO regimen in the ongoing first-line Phase 3 study * Data highlight the role of dual-targeting EGFR and MET, key drivers of tumor growth and resistance seen in 80 to 90 percent of HNSCC NEW BRUNSWICK, N.J., Oct. 25, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new results from Cohort 5 of the Phase 1b/2 OrigAMI-4 study showing deep and durable responses with first-line subcutaneous amivantamab and hyaluronidase-lpuj plus a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).(1) These findings support the ongoing pivotal Phase 3 OrigAMI-5 study and further expand the clinical development program for subcutaneous amivantamab for patients with head and neck cancer.(2)
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