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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer

Cohort 2 of the OrigAMI-4 study showed a 6% confirmed ORR in first-line HPV-negative head and neck cancer, Johnson & Johnson reported on February 19, 2026, at the 2026 MHNCS.
In the first-line setting, outcomes remain poor for PD-L1-positive, HPV-unrelated disease, following FDA approval of subcutaneous RYBREVANT FASPRO in December 2025.
Data showed a 74% clinical benefit rate, median time to first response of 9.7 weeks, and median PFS of 7.7 months, with tumor shrinkage in 82%.
The Phase 3 OrigAMI-5 will evaluate subcutaneous amivantamab with carboplatin and pembrolizumab, as a first-line treatment, with median follow-up 10.4 months and 46 percent still on treatment, investigators said.
As a first-in-class fully human bispecific, RYBREVANT FASPRO carries safety risks: ILD/pneumonitis led to discontinuation in three patients, and prophylactic anticoagulation was used due to VTE risk, with 80% receiving it.

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