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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

Medical Information

Use of RYBREVANT FASPRO in Head & Neck Cancer - OrigAMI-5 Study

Last Updated: 06/02/2026

SUMMARY

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).¹
OrigAMI-5 (NCT07276399) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety of amivantamab SC plus pembrolizumab and carboplatin vs standard of care (SOC; 5-fluorouracil [5-FU] plus pembrolizumab and platinum therapy [cisplatin or carboplatin, per investigator’s discretion]) in patients with treatment-naïve recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The dual primary endpoints are blinded independent central review (BICR)-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and overall survival (OS). Enrollment is planned for approximately 500 patients. Results have not yet been published.²^,³

ONGOING clinical study

OrigAMI-5 Study

Study Design/Methods

Ongoing, phase 3, randomized, open-label, multicenter study designed to assess the efficacy and safety of amivantamab SC plus pembrolizumab and carboplatin vs SOC
(5-FU plus pembrolizumab and cisplatin or carboplatin [per investigator’s discretion]) in patients with treatment-naïve R/M HNSCC.²^,³
The study design is shown in Figure: OrigAMI-5 Study Design.

OrigAMI-5 Study Design²^,³

OrigAMI-5 (ClinicalTrials.gov Identifier: NCT07276399) enrollment period: December 2025 onwards; estimated study completion: June 18, 2029.
Abbreviations: 5-FU, 5-fluorouracil; AUC, area under the curve; BICR, blinded independent central review; C, cycle; CPS, combined positive score; D, day; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EORTC IL-46, European Organization for Research and Treatment of Cancer Quality of Life Item Library-46; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-HN43, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43; HNSCC, head and neck squamous cell carcinoma; HPV, human papillomavirus; ILD, interstitial lung disease; IV, intravenous; MET, mesenchymal-epithelial transition; ORR, objective response rate; OS, overall survival; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; PRO, patient-reported outcome; Q3W, every 3 weeks; QW, once weekly; R, randomization; R/M, recurrent/metastatic; rHuPH20, recombinant human hyaluronidase; RECIST, Response Evaluation Criteria in Solid Tumors; SC, subcutaneous.
^aCo-formulated with rHuPH20.
^b3360 mg if body weight ≥80 kg.
^cC1D1 only: initial dose 1600 mg (2240 mg if body weight ≥80 kg).
^dFor the European Union and any applicable country/region, the primary endpoint is OS only.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 28 May 2026.

References

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1	Leighl NB, Akamatsu H, Lim SM, 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. J Clin Oncol. 2024;42(30):3593-3605.
2	Janssen Research & Development, LLC. A study of amivantamab in addition to standard of care agents (SOC) compared with SOC alone in participants with recurrent/metastatic head and neck cancer (OrigAMI-5). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 May 28]. Available from: https://clinicaltrials.gov/study/NCT07276399 NLM Identifier: NCT07276399.
3	Haddad R, Ferrarotto R, Guo Y, et al. OrigAMI-5: a randomized, phase 3 study of subcutaneous amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 29-June 2, 2026; Chicago, IL.

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