No more options after chemo and immunotherapy? A new bispecific antibody is changing the game for HPV-unrelated head and neck cancer.

Patients with HPV-unrelated recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) often face rapid progression and very limited options after platinum-based chemotherapy and PD inhibitors. This group represents ∼75% of all cases and has the poorest prognosis.

New hope from ASCO 2026: amivantamab.

Amivantamab is a first-in-class fully-human bispecific antibody.

The designation is supported by the OrigAMI-4 study – an international trial in 11 countries presented at ASCO Chicago:

In 102 heavily pretreated patients, treatment led to tumor reduction or disappearance in 43 patients: 28 with significant tumor shrinkage and 15 with complete disappearance.

What’s next:

The ongoing Phase 3 OrigAMI-5 (NCT07276399) is now testing subcutaneous amivantamab + pembrolizumab + carboplatin vs. standard 5FU + pembrolizumab + platinum as first-line therapy for HPV-unrelated R/M HNSCC.

Source: Johnson & Johnson / FDA announcement + OrigAMI-4 data ASCO 2026

Read more: morningstar.com