Key Takeaways:
Johnson & Johnson's subcutaneous amivantamab (RYBREVANT FASPRO) produced a 42% confirmed overall response rate in patients with advanced head and neck squamous cell carcinoma who had already received immunotherapy and chemotherapy, according to pivotal data from the Phase 1b/2 OrigAMI-4 study presented at the ASCO 2026 annual meeting.
"Patients with recurrent or metastatic head and neck cancer who have already been treated with immunotherapy and chemotherapy face very poor outcomes," said Barbara Burtness, medical oncologist at Yale Cancer Center and lead investigator. "The high response seen with subcutaneous amivantamab on its own, including more than one-third of responders achieving complete responses, and the durability of those responses, suggests it has the potential to meaningfully improve expectations for these patients."
The study enrolled 102 patients with recurrent or metastatic HNSCC who had progressed on prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy, excluding those with HPV-positive oropharyngeal cancer. By blinded independent central review, the complete response rate was 15%, with a 27% partial response rate. Clinical benefit rate reached 63%, and median time to first response was 6.6 weeks. At a median follow-up of 11.8 months, median duration of response had not yet been reached. Median progression-free survival was 6.8 months, and median overall survival was 12.5 months.
The safety profile was consistent with prior reports, with most treatment-related adverse events graded mild to moderate. The most common on-target events included hypoalbuminemia (50%), rash (37%), paronychia (34%) and dermatitis acneiform (34%). Administration-related reactions occurred in 15% of patients with no Grade 3 or higher events reported. Treatment-related discontinuations remained low at 8%.
The results address a significant unmet need. Up to half of patients with head and neck cancer experience recurrence or metastatic disease, and five-year survival for those with advanced disease is approximately 15%. Current treatment options provide response rates rarely exceeding 24%, with few patients achieving complete responses. J&J has submitted a supplemental Biologics License Application to the FDA seeking approval for RYBREVANT FASPRO in this indication, following Breakthrough Therapy Designation. The company is also evaluating the drug in a Phase 3 first-line setting through the OrigAMI-5 study. If approved, RYBREVANT FASPRO would become the first subcutaneous therapy available for advanced HNSCC, expanding its approved use beyond EGFR-mutated non-small cell lung cancer into a new multi-billion dollar oncology market.
This article is for informational purposes only and does not constitute investment advice.
