A headline from the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this week has generated considerable attention: “Cancer jab can eradicate entire tumours in patients, trial shows.” The data, presented on May 30 and published simultaneously in the Journal of Clinical Oncology, is impressive. It also needs careful framing.
What it is — and what it isn’t
The drug is amivantamab (marketed as RYBREVANT FASPRO), an injectable bispecific monoclonal antibody developed by Janssen, a Johnson & Johnson company. It is not a vaccine. Unlike cancer vaccines — which train the immune system to recognize tumour-specific antigens — amivantamab is a pre-made antibody that directly binds to two targets on cancer cells: EGFR and MET. It also engages immune cells through its Fc region (antibody-dependent cellular cytotoxicity and phagocytosis), giving it a triple mechanism of action.
The Guardian’s “jab” framing is journalistic shorthand for an injection, but it risks conflating this with therapeutic vaccines. Mechanism matters.
The OrigAMI-4 trial
The data come from Cohort 1 of the OrigAMI-4 (NCT06385080) phase 1b/2 open-label trial, an international study conducted across 11 countries.
The patient population is among the most challenging in oncology: recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after both platinum-based chemotherapy and PD-1/PD-L1 checkpoint inhibitors. These are patients who have exhausted the two standard-of-care treatment lines. HPV-positive oropharyngeal cancer — which has a better prognosis — was excluded.
Kevin Harrington, MBBS, PhD, professor of biological cancer therapies at the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust in London, presented the results on 102 efficacy-evaluable patients who received subcutaneous amivantamab every three weeks after an initial weekly loading period.
The numbers
| Endpoint | Result |
|---|---|
| Confirmed overall response rate (ORR) | 42% (95% CI 32–52) |
| Complete response (CR) — tumour eradication | 15% (15 of 102 patients) |
| Partial response | 27% |
| Clinical benefit rate | 63% (95% CI 53–72) |
| Median time to first response | 6.6 weeks |
| Median duration of response | Not yet reached (at 11.8 months follow-up) |
| Median progression-free survival | 6.8 months |
| Median overall survival | 12.5 months |
| Patients with any tumour shrinkage | 82% |
The 15% complete response rate — 15 patients whose detectable tumours disappeared entirely — is the standout figure. In a heavily pre-treated HNSCC population, available therapies typically achieve ORRs in the 10–24% range with extremely rare complete responses. “We’re seeing responses that are both unprecedented in magnitude and durability,” Harrington said.
The ORR of 42% was confirmed by blinded independent central review (BICR), meeting the primary endpoint.
For context, the larger data set at ASCO 2026 (102 patients) more than doubled the earlier ESMO 2025 cohort (38 patients) and matured the complete response rate from approximately 2.6% (1 patient) to 15% — a meaningful increase that likely reflects both a larger sample and longer follow-up allowing deeper responses to become measurable.
Safety
Treatment-related side effects were predominantly mild to moderate. Common adverse events included hypoalbuminemia (50%), rash (37%), paronychia (34%), and dermatitis acneiform (34%). Infusion-related reactions occurred in 15% with none reaching grade 3 or higher. Only 8% of patients discontinued treatment due to adverse events — a low rate for a population receiving third-line therapy.
Context and caution
The Guardian’s key claims check out against the data presented at ASCO: 42% ORR, 15% complete responses, manageable safety. But several qualifications matter:
Phase 1b/2 — not phase 3. The trial remains early-stage. The results supported the expansion of OrigAMI-4 into additional cohorts but have not yet led to regulatory approval in HNSCC. Amivantamab is already approved for EGFR-mutant non-small cell lung cancer in more than 40 countries, but the HNSCC indication follows a separate path.
Specialized population. HPV-negative HNSCC that has progressed through checkpoint inhibitors represents a distinct biological subtype. Results may not generalize to other head and neck cancers or earlier treatment lines.
Response depth ≠ cure. Complete response is not the same as cure. Some of these 15 patients may experience disease recurrence. Durable follow-up data are pending.
Still, for patients with recurrent/metastatic HNSCC who have exhausted platinum and immunotherapy — a group with extremely limited options — a 15% complete response rate with an 8% discontinuation rate is a meaningful advance. The trial’s expansion into additional cohorts (combination with chemotherapy, earlier treatment lines) will determine whether this becomes a new standard of care.
Source: Harrington, K. et al. “Efficacy and safety of subcutaneous amivantamab in recurrent/metastatic head and neck squamous cell carcinoma (OrigAMI-4).” Journal of Clinical Oncology 44 (suppl; abstr #6008). Presented at ASCO 2026, Chicago.
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Trial registration: ClinicalTrials.gov NCT06385080
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Sponsor: Janssen Research & Development, LLC (Johnson & Johnson)