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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

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Full Prescribing Information (English)

Use of RYBREVANT FASPRO in Colorectal Cancer - OrigAMI-2 Study

Last Updated: 04/22/2026

SUMMARY

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).¹
OrigAMI-2 (NCT06662786) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety of amivantamab SC vs cetuximab intravenous (IV), both in combination with chemotherapy, as first-line (1L) treatment in patients with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer (CRC). Chemotherapy regimens consisted of either mFOLFOX6 (modified combination of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and oxaliplatin) or FOLFIRI (combination of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan hydrochloride). The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Enrollment is planned for approximately 1000 patients. Results have not yet been published.²^,³

ONGOING clinical study

OrigAMI-2 Study

Study Design/Methods

Ongoing, phase 3, randomized, open-label, multicenter study designed to assess the efficacy and safety of amivantamab SC vs cetuximab IV, both in combination with mFOLFOX6 or FOLFIRI (per investigator’s discretion), as 1L treatment in patients with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided CRC.²^,³
The study design is shown in Figure: OrigAMI-2 Study Design.
Patients may undergo curative-intent surgery or procedure during the treatment period, if appropriate.²
- An independent committee will review all patients prior to the intervention.

OrigAMI-2 Study Design²^,³

OrigAMI-2 (ClinicalTrials.gov Identifier: NCT06662786) enrollment period: October 2024 onwards; estimated study completion: December 15, 2028.
Abbreviations: BICR, blinded independent central review; C, cycle; CR, complete response; CRC, colorectal cancer; D, day; DCR, disease control rate; dMMR, mismatch repair deficiency; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-CR29, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29; FOLFIRI, combination of leucovorin calcium [folinic acid] or levoleucovorin, 5-fluorouracil, and irinotecan hydrochloride; HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; IV, intravenous; MET, mesenchymal-epithelial transition; mFOLFOX6, modified combination of leucovorin calcium [folinic acid] or levoleucovorin, 5-fluorouracil, and oxaliplatin; MSI-H, microsatellite instability-high; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PFS2, PFS after first subsequent therapy; PR, partial response; PRO, patient-reported outcome; Q2W, every 2 weeks; QW, once weekly; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; rHuPH20, recombinant human hyaluronidase; SC, subcutaneous; SD, stable disease; TTF, time to treatment failure; TTR, time to response; VEGF, vascular endothelial growth factor; WT, wild-type.
^aLeft-sided CRC is defined as histologically or cytologically confirmed primary tumor arising from the splenic flexure, descending colon, sigmoid colon, rectosigmoid, or rectum.
^bPrior adjuvant (fluoropyrimidine ± oxaliplatin/irinotecan [≤6 months of treatment] or radiation with radiosensitizing chemotherapy) or neoadjuvant (fluoropyrimidine monotherapy) chemotherapy in nonmetastatic disease is allowed but must have concluded >12 months before CRC recurrence/metastases.
^cBrain metastases that are definitively and locally treated, clinically stable, and asymptomatic for ≥2 weeks.
^dAmivantamab SC was co-formulated with 2000 U/mL rHuPH20.
^e2240 mg if body weight ≥80 kg.
^fDefined as ≤2 metastatic sites and ≤5 metastatic lesions in each site.
^gFor patients who undergo curative-intent surgery/procedure during the treatment period, preintervention imaging will be used to determine the best response of CR, PR, or SD, and postintervention tumor assessments will be used to determine the time and location of PD (eg, recurrence at the site of resection or a distant new lesion).

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 14 April 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	Arnold D, Cervantes A, Ducreux M, et al. OrigAMI-2: a randomized, phase 3 study of amivantamab vs cetuximab, both in combination with FOLFOX or FOLFIRI, as first-line treatment in left-sided RAS/BRAF wild-type metastatic colorectal cancer. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.
3	Janssen Research & Development, LLC. A randomized, open-label phase 3 study of amivantamab and mFOLFOX6 or FOLFIRI versus cetuximab and mFOLFOX6 or FOLFIRI as first-line treatment in participants with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 April 14]. Available from: https://clinicaltrials.gov/study/NCT06662786 NLM Identifier: NCT06662786.