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amivantamab SC

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Use of RYBREVANT in Colorectal Cancer - OrigAMI-2 Study

Last Updated: 05/31/2025

SUMMARY

RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹
Amivantamab for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).²
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 left-sided RAS/BRAF wild-type unresectable or metastatic colorectal cancer (CRC). Chemotherapy regimens consisted of either FOLFOX (combination of leucovorin calcium or levoleucovorin, 5-fluorouracil, and oxaliplatin) or FOLFIRI (combination of leucovorin calcium or levoleucovorin, 5-fluorouracil, 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.³^,⁴

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 FOLFOX or FOLFIRI (per investigator’s discretion), as 1L treatment in patients with left-sided RAS/BRAF wild-type unresectable or metastatic CRC³^,⁴
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.³
- An independent committee will review all patients prior to the intervention.

OrigAMI-2 Study Design³^,⁴

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 Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-CR29, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29; FOLFIRI, combination of leucovorin calcium or levoleucovorin, 5-fluorouracil, and irinotecan hydrochloride; FOLFOX, combination of leucovorin calcium or levoleucovorin, 5-fluorouracil, and oxaliplatin; HER2, human epidermal growth factor receptor 2; IA, investigator-assessed; ILD, interstitial lung disease; IV, intravenous; MET, mesenchymal-epithelial transition; 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; 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) therapy 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 29 May 2025.

References

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1	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.
2	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.
3	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.
4	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 2025 May 29]. Available from: https://clinicaltrials.gov/study/NCT06662786 NLM Identifier: NCT06662786.