Johnson & Johnson reports 77% overall response rate for Rybrevant Faspro in first‑line head‑and‑neck cancer trial
Johnson & Johnson presented data from Cohort 5 of its Phase 1b/2 OrigAMI‑4 study at the ESMO Congress 2026. The subcutaneous amivantamab (Rybrevant Faspro) plus pembrolizumab and carboplatin regimen achieved a confirmed overall response rate of 77 % in 22 patients with non‑HPV‑associated recurrent or metastatic head‑and‑neck squamous cell carcinoma, including a 14 % complete‑response rate. Responses were durable, with 65 % still ongoing at a median follow‑up of 10.6 months. The company said the results support continued evaluation in the pivotal Phase 3 OrigAMI‑5 trial.
Why it matters
The company says the data justify advancing Rybrevant Faspro into a larger Phase 3 study, which could eventually add a new first‑line oncology product to its pipeline and generate future revenue. Investors will watch the Phase 3 outcome for potential commercial impact.
Key facts
- 1The confirmed overall response rate in non‑HPV‑associated HNSCC patients was 77 % (95 % CI 55‑92). prnewswire.com
- 2Complete responses occurred in 14 % of those patients. prnewswire.com
- 365 % of responses remained ongoing at a median follow‑up of 10.6 months. prnewswire.com
- 4The study enrolled 22 patients in this cohort; 29 patients received treatment overall, with one patient ineligible. prnewswire.com
- 5The regimen combined subcutaneous amivantamab, pembrolizumab and up to six cycles of carboplatin, administered every three weeks. prnewswire.com
- 6Johnson & Johnson plans to evaluate the regimen further in the pivotal Phase 3 OrigAMI‑5 trial. prnewswire.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.