J&J Reports 77% Response Rate in HPV-Unrelated Head and Neck Cancer Group

Johnson & Johnson announced Oct. 25 that an investigational regimen produced a 77% confirmed response rate in a 22-person HPV-unrelated head and neck cancer subgroup. The confirmed rate across all 29 evaluable participants in Cohort 5 of the Phase 1b/2 OrigAMI-4 study was 66%.

Seventeen participants in the HPV-unrelated subgroup responded: three had complete responses and 14 had partial responses. In a separate group of seven participants with HPV-related oropharyngeal cancer, two responded, a rate of 29%.

The cohort enrolled 30 people with recurrent or metastatic head and neck squamous cell carcinoma. One was ineligible, leaving 29 in the efficacy analysis. Participants had not previously received treatment for their recurrent or metastatic disease, and enrollment required a PD-L1 combined positive score of at least 1.

The regimen combined pembrolizumab and carboplatin with subcutaneous amivantamab co-formulated with hyaluronidase-lpuj (RYBREVANT FASPRO). Amivantamab is designed to target EGFR and MET.

The clinical data cutoff was June 16, 2026. After a median 10.6 months of follow-up, 65% of the responses in the HPV-unrelated group were ongoing. The median time to first response was 9.4 weeks. Median progression-free survival in that subgroup was 7.7 months, while median overall survival had not been reached. Seventy-seven percent were alive at one year.

Four grade 5 adverse events occurred among the 30 participants: myocardial infarction, pneumonia, urinary tract infection and respiratory failure. None was attributed to the study treatment. Treatment-related side effects led eight participants to stop at least one study drug; one stopped all study drugs for that reason.

OrigAMI-4 was nonrandomized, so its results do not directly compare the regimen with another treatment. J&J is evaluating the combination in the randomized Phase 3 OrigAMI-5 study, which compares it with pembrolizumab, platinum chemotherapy and 5-fluorouracil.

“The numbers are still small, and the Phase III trial will be the real test,” said Professor Kristian Helin, chief executive of The Institute of Cancer Research, London.