- Complete responses were seen in 14% of patients with head and neck squamous cell carcinoma (HNSCC) other than human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC); 65% of responses in this subgroup remained ongoing at clinical cutoff1
- These Phase 1b/2 study results support continued evaluation of the investigational amivantamab-based regimen in the ongoing first-line Phase 3 study
- Data highlight the role of dual-targeting EGFR and MET, key drivers of tumour growth and resistance seen in 80-90% of HNSCC2
BEERSE, BELGIUM, Oct. 25, 2026 (GLOBE NEWSWIRE) — Johnson & Johnson today announced new results from Cohort 5 of the Phase 1b/2 OrigAMI-4 study with first-line subcutaneous RYBREVANT®▼ (amivantamab) plus a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with advanced recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) other than human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC).1 These findings support the ongoing pivotal Phase 3 OrigAMI-5 study and further expand the clinical development programme for subcutaneous amivantamab for patients with head and neck cancer.
Among patients with HNSCC other than HPV-associated OPSCC, results demonstrated a confirmed overall response rate (ORR) of 77%, including 14% achieving complete responses.1 Tumour shrinkage was observed in all evaluable patients, and nearly two-thirds of responses remained ongoing at a median follow-up of 10.6 months.1 These findings were presented as a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract #1539RO).
Unmet need remains in first-line head and neck cancer treatment
For people with recurrent or metastatic head and neck cancer, the first-line treatment decision after progression comes at a critical point in an aggressive disease often associated with poor prognosis.3 While some patients benefit from the current standard of care, many experience disease progression while facing symptoms that can profoundly affect daily life, including the ability to eat, swallow and speak.4,5 Nearly 60% of patients do not go on to receive subsequent treatment, underscoring the need to help more patients achieve meaningful tumour reduction and durable responses from the start.3
Expert and company perspectives on the role of amivantamab in advancing first-line treatment
“Patients with recurrent or metastatic head and neck cancer continue to face a poor prognosis, highlighting the need for new treatment approaches,” said Kevin Harrington, M.D., Ph.D., Professor of Biological Cancer Therapies at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.* “The data presented from Cohort 5 of the OrigAMI-4 study are promising, with the triplet combination of amivantamab, a PD-1 inhibitor and chemotherapy demonstrating encouraging response rates, ongoing responses and early survival findings in patients with HPV-unassociated tumours in the recurrent or metastatic first-line setting. These findings offer an opportunity to explore how we might improve outcomes for patients with this challenging disease.”
“We’ve already seen what subcutaneous amivantamab may offer patients with head and neck cancer after their disease has progressed. Now, we see the potential impact of using this approach earlier in recurrent or metastatic disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “Our experience with amivantamab in lung cancer has helped establish the potential of dual EGFR/MET targeting, and these results support continued evaluation of this approach in head and neck cancer.”
“People living with recurrent or metastatic head and neck cancer need treatments that can deliver meaningful benefits from the very beginning of their treatment journey,” said Henar Hevia, Ph.D., EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. “These results reinforce our ambition to raise expectations of what might be possible for patients with this challenging disease and give us further confidence to advance subcutaneous amivantamab in the recurrent or metastatic first-line setting, as we continue to evaluate this approach in Phase 3.”
Amivantamab demonstrates meaningful anti-tumour activity in first-line disease
Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab in combination with pembrolizumab (PD-1 inhibitor) and up to six cycles of carboplatin in previously untreated patients with recurrent or metastatic HNSCC.1 Patients received treatment every three weeks following the initial treatment period, with an administration time of five minutes or less.1 The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1).**1 Response rates were assessed separately in patients with HPV-associated OPSCC (n=7) and patients with all other forms of HNSCC (n=22), given known differences in how these patient populations respond to EGFR-targeted bispecifics.1
Thirty patients received subcutaneous amivantamab in combination with pembrolizumab and carboplatin, and 29 were included in the efficacy analysis.1 One patient was deemed ineligible.1 Among 22 patients with forms of HNSCC other than HPV-associated OPSCC, the confirmed ORR was 77% (95% confidence interval [CI], 55-92), including complete responses in 14% and partial responses in 64%.1 Responses occurred at a median of 9.4 weeks, with 65% ongoing at a median follow-up of 10.6 months.1 Four patients (18%) had stable disease and one (5%) had progressive disease.1 Median overall survival was not reached and 77% of patients were alive at one year.1 The remaining seven patients had HPV-associated OPSCC, with an ORR of 29% (95% CI, 4-71).1
The safety profile of subcutaneous amivantamab in combination with pembrolizumab and carboplatin was consistent with the individual agents.1 The most common adverse events were anaemia (73%), hypoalbuminaemia (63%), thrombocytopenia (63%) and stomatitis (57%).1 Administration-related reactions associated with subcutaneous amivantamab occurred in 13% of patients, with no Grade 3 or higher events reported.1
The Cohort 5 findings build on earlier first-line results from the OrigAMI-4 programme, including Cohort 2 data evaluating subcutaneous amivantamab in combination with pembrolizumab recently published in Clinical Cancer Research.6
About the OrigAMI-4 Study
OrigAMI-4 is an open-label Phase 1b/2 study evaluating subcutaneous amivantamab in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).7 The study includes six cohorts, including Cohort 5, which studied subcutaneous amivantamab across different treatment settings and regimens.1 Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab, administered every three weeks, in combination with pembrolizumab and carboplatin in patients with R/M HNSCC receiving first-line treatment whose tumours tested positive for programmed death-ligand 1 (PD-L1), with a combined positive score (CPS) of one or greater.1 The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1).1
About Head and Neck Squamous Cell Carcinoma
HNSCC is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity and salivary glands.8 It represents approximately 4.5% of all cancers worldwide and is the seventh most common cancer globally.8 Major risk factors include tobacco and alcohol use, as well as infection with high-risk HPV.8 Around 75% of cases are HPV-unassociated, which is typically linked with a poorer prognosis and reduced response to treatment.9,10 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease.11
About Amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.12,13,14
The European Commission (EC) has approved amivantamab in the following indications (intravenous and subcutaneous):15
- In combination with lazertinib for the first-line treatment of adult patients with advanced non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
- In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
- In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
- As monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.16
For a full list of undesirable effects and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.15
▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/innovativemedicine/emea/. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea.
Caution Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
*Kevin Harrington, M.D., Ph.D. has served as a consultant to Johnson & Johnson; he has not been paid for any media work.
** RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.
CP-608853
October 2026
###
References:
1 Swiecicki P, et al. Amivantamab + pembrolizumab + carboplatin in first-line recurrent/metastatic head & neck squamous cell cancer (1L R/M HNSCC) Results from the phase 1b/2 OrigAMI-4 study. Presented at: European Society for Medical Oncology (ESMO) 2026 Congress; October 25, 2026; Madrid.
2 Kalyankrishna S, Grandis JR. Epidermal growth factor receptor biology in head and neck cancer. J Clin Oncol. 2006;24(17):2666–2672.
3 Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019;394(10212):1915-1928. doi:10.1016/S0140-6736(19)32591-7.
4 Nissi L, et al. Recurrence of head and neck squamous cell carcinoma in relation to high-risk treatment volume. Clin Transl Radiat Oncol. 2021;27:139-146. doi:10.1016/j.ctro.2021.01.013.
5 Zebralla V, Wichmann G, Pirlich M, et al. Dysphagia, voice problems, and pain in head and neck cancer patients. Eur Arch Otorhinolaryngol. 2021;278(10):3985-3994. doi:10.1007/s00405-020-06584-6.
6 Kao H-F, et al. Amivantamab plus pembrolizumab in previously untreated recurrent/metastatic head and neck squamous cell cancer: Results from the phase 1b/2 OrigAMI-4 study. Clin Cancer Res. 2026 Sep 15. doi: 10.1158/1078-0432.CCR-26-1372.
7 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). Available at: https://clinicaltrials.gov/study/NCT06385080?term=OrigAMI-4&limit=10&rank=1. Accessed October 2026.
8 Barsouk A, et al. Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Medical Sciences. 2023; 11(2):42.
9 Hartmann, S, et al. HGF/Met Signaling in Head and Neck Cancer: Impact on the Tumor Microenvironment. Clin Cancer Res. 2016 Aug 15;22(16):4005-13. doi: 10.1158/1078-0432.CCR-16-0951.
10 Ghiani L, Chiocca S. High Risk-Human Papillomavirus in HNSCC: Present and Future Challenges for Epigenetic Therapies. International Journal of Molecular Sciences. 2022;23(7):3483.
11 Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. New England Journal of Medicine. 2016;375(19):1856-1867.
12 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833.
13 Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116.
14 Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs. 2017;9(1):114-126.
15 European Medicines Agency. Amivantamab Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf. Accessed October 2026.
16 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.
CONTACT: Media contact: Pasquale Monteleone [email protected] Investor contact: JessMargevich [email protected]
