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Subcutaneous RYBREVANT®▼(amivantamab) delivers promising 45 percent overall response rate with median duration of response of 7.2 months in recurrent or metastatic head and neck cancer

19-10-2025

Responses were rapid and durable, and tumour shrinkage was observed in 82 percent of patients¹

New findings from this investigational study build on the strength of the data for amivantamab in non-small cell lung cancer and broadens its potential across additional solid tumours¹^,2

BEERSE, BELGIUM, , Oct. 19, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced promising new results from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous (SC) RYBREVANT^®▼(amivantamab) monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and platinum-based chemotherapy.¹ Data were presented during a mini-oral session at the European Society for Medical Oncology (ESMO) 2025 Congress (Oral Abstract #1327MO).¹

Patients with R/M HNSCC have limited options and poor outcomes after disease progression on current treatment options.³ Many are unable to receive further treatment, and for those who do, response rates with available therapies are typically 10 to 24 percent.³^,4,5 Survival remains short, with a median of 6 to 9 months, and may be even shorter among patients with HPV-unrelated disease.¹^,³^,6Patients also face a significant burden of symptoms such as difficulty swallowing, impaired speech, pain and fatigue.⁷ Epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET), two key tumour drivers, are overexpressed in 80 to 90 percent of HNSCC tumours, highlighting their role as potential treatment targets.⁸^,9,10Amivantamab, the first bispecific antibody approved for lung cancer, inhibits both EGFR and MET, in addition to recruiting immune cells to attack cancer cells.¹¹

“Patients with recurrent or metastatic head and neck cancer face an aggressive disease that significantly impacts their quality of life,” said Professor Kevin Harrington*, MBBS, Ph.D., Professor in Biological Cancer Therapies at The Institute of Cancer Research, Royal Marsden Hospital, London, UK, and primary study investigator. “These results represent one of the most encouraging response rates we’ve seen in this difficult-to-treat setting, with durability that could meaningfully extend the time patients live without their disease progressing.”

In Cohort 1 of the OrigAMI-4 study, treatment with SC amivantamab resulted in an overall response rate (the primary endpoint) of 45 percent in 38 efficacy-evaluable patients with R/M HNSCC unrelated to HPV with disease progression on or after a PD-1 or PD-L1 checkpoint inhibitor and platinum-based chemotherapy (95 percent confidence interval [CI], 29-62).¹ Responses occurred quickly, with a median time to first response of 6.4 weeks (range, 5.7-18.3), and were durable, with a median duration of response of 7.2 months (95 percent CI, 5.3-not estimable [NE]).¹^,12 Tumour shrinkage of target lesions was observed in 82 percent of patients after 8.3 months of follow-up.¹ Median progression-free survival was 6.8 months (95 percent CI, 4.2-9.0), while median overall survival had not yet been reached (95 percent CI, 7.7-NE).¹

“These findings from the OrigAMI-4 study demonstrate the potential of amivantamab to help shift the treatment paradigm for people with recurrent or metastatic head and neck squamous cell carcinoma, who may otherwise face a devastating outlook,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “We look forward to advancing our work in this area of high unmet need in subsequent cohorts, with the goal of unlocking the full potential of amivantamab to improve outcomes for patients whose tumours are driven by EGFR and MET alterations.”

The safety-evaluable population included 86 patients who received at least one dose of SC amivantamab monotherapy.¹ The safety profile was consistent with prior SC amivantamab monotherapy studies, with no new safety signals observed.¹ The most common treatment-emergent adverse events (TEAEs) of any grade were fatigue (31 percent), hypoalbuminemia (31 percent), stomatitis (23 percent), and dermatitis acneiform (20 percent). ¹ The most common Grade 3 or higher TEAEs were dermatitis acneiform (seven percent), anaemia (six percent), fatigue (five percent), and lymphopenia (five percent).¹ Administration-related reactions occurred in seven percent of patients, all mild to moderate (Grade 1-2), with no severe events.¹ Treatment discontinuation due to treatment-related adverse events occurred in two percent of patients.¹

“These data highlight the broader potential of amivantamab-based therapies across solid tumours where the EGFR and/or MET pathways are activated,” said Kiran Patel, Vice President, Global Head, Solid Tumour Clinical Development and Diagnostics, Johnson & Johnson Innovative Medicine. “We are building on the progress made with amivantamab for patients with non-small cell lung cancer in other hard-to-treat diseases like head and neck cancer. By targeting EGFR and MET while also engaging the immune system, amivantamab could provide new options for more patients who have few effective treatments.”

Based on these results, Johnson & Johnson is initiating further study of SC amivantamab in head and neck cancer with the Phase 3 OrigAMI-5 study, which is evaluating first-line SC amivantamab with pembrolizumab and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) in patients with HPV-unrelated R/M HNSCC. In addition to supporting further evaluation in first-line R/M HNSCC, these findings add to the evidence supporting the role of amivantamab-based treatments across multiple solid tumours, including non-small cell lung cancer, colorectal cancer and HNSCC.²^,13,14

About the OrigAMI-4 Study

OrigAMI-4 is an open-label Phase 1b/2 study evaluating SC amivantamab in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).¹⁵ The study includes five cohorts, including Cohort 1 which studied SC amivantamab as monotherapy in patients with human papillomavirus (HPV)-unrelated R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy.¹⁵ Patients with prior anti-EGFR therapy were excluded.¹⁵ Subcutaneous amivantamab was administered every three weeks (Q3W) at 2400 mg, or 3360 mg for patients weighing 80 kg or more.¹^,¹⁵ The primary endpoint is overall response rate (ORR), assessed by blinded independent central review (BICR) using RECIST v1.1**.¹

About Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma (HNSCC) is the most common type of head and neck cancer, accounting for more than 90 percent of cases and approximately 4.5 percent of all cancers worldwide.¹⁶ It develops in the mucosal linings of the oral cavity, oropharynx, hypopharynx, and larynx.¹⁷ Major risk factors include tobacco and alcohol use, as well as infection with high-risk HPV.¹⁰ Around 75 percent of cases are HPV-negative, which is typically associated with a poorer prognosis and reduced response to treatment.¹⁰^,18 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients are diagnosed at an advanced stage, and R/M HNSCC continues to carry a poor prognosis.³

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.¹⁹^,20,21,22

The European Commission (EC) has approved amivantamab in the following indications:²²

Intravenous amivantamab:

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 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 treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy.

Subcutaneous amivantamab:

In combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
As monotherapy for 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.²³

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.²²

▼ 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://innovativemedicine.jnj.com/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea/. Janssen-Cilag International NV, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies.

Cautions 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 subcutaneous 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/ 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.

*Prof. Kevin Harrington, MBBS, 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 solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.

¹ Harrington K, et al. Amivantamab in recurrent/metastatic head & neck squamous cell cancer after disease progression on checkpoint inhibition and chemotherapy [ESMO abstract 1327MO]. Presented at: European Society for Medical Oncology 2025 Congress; October 17-21, 2025; Berlin, Germany.

² Yang, JCH, et al. Overall Survival with Amivantamab-Lazertinib in EGFR-mutant Advanced NSCLC. N Engl J Med. 2025.

³ 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.

⁴ Cohen EEW, Soulières D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019;393(10167):156-167. doi:10.1016/S0140-6736(18)31999-8

⁵ Fayette J, Licitra L, Harrington K, et al. INTERLINK-1: A Phase III, Randomized, Placebo-Controlled Study of Monalizumab plus Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Clinical Cancer Research. 2025;31(13):2617-2627.

⁶ Tahara M, Greil R, Rischin D, et al. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. European Journal of Cancer. 2025;221:115395.2025.115395

⁷ Hecht M, et al. Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer. BMC Cancer. 2020 Sep 29;20(1):933.

⁸ Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current Therapy for Metastatic Head and Neck Cancer: Evidence, Opportunities, and Challenges. American Society of Clinical Oncology Education Book. 2022;42:1-14.

⁹ Rothenberger NJ, Stabile LP. Hepatocyte Growth Factor/c-Met Signaling in Head and Neck Cancer and Implications for Treatment. Cancers. 2017; 9(4):39.

¹⁰ Hartmann, S, et al. HGF/Met Signaling in Head and Neck Cancer: Impact on the Tumor Microenvironment. Clinical Cancer Research 15 August 2016; 22 (16): 4005–4013.

¹¹ Chen W, et al. Bispecific antibody for lung cancer: mechanisms and clinical insights. Front Immunol. 2025 May 29;16:1572802. doi: 10.3389/fimmu.2025.1572802.

¹² Harrington K, et al. Amivantamab in recurrent/metastatic head & neck squamous cell cancer after disease progression on checkpoint inhibition and chemotherapy [ESMO abstract 1327MO]. Abstract presented in: European Society for Medical Oncology 2025 Congress Abstract Book, Annals of Oncology. 2025.

¹³ ClinicalTrials.gov. A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1). Available at: https://clinicaltrials.gov/study/NCT05379595. Accessed October 2025.

¹⁴ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Available at: https://clinicaltrials.gov/study/NCT04487080. Accessed October 2025.

¹⁵ 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 2025.

¹⁶ Barsouk A, et al. Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Medical Sciences. 2023; 11(2):42. https://doi.org/10.3390/medsci11020042

¹⁷ Sun Z, et al. Head and Neck Squamous Cell Carcinoma: Risk Factors, Molecular Alterations, Immunology and Peptide Vaccines. Int J Pept Res Ther. 2022;28(1):19.

¹⁸ 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. https://doi.org/10.3390/ijms23073483

¹⁹ Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res 2016;76(13)(suppl 27216193):3942-3953.

²⁰ 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.

²¹ Yun J, 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.

²² European Medicines Agency. Amivantamab Summary of Product Characteristics. July 2025. Available at: https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf. Accessed October 2025.

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