Efficacy and safety of a cetuximab biosimilar compared with Erbitux in patients with RAS wild-type metastatic colorectal cancer
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Cetuximab, an epidermal growth factor receptor monoclonal antibody, is a key therapy for RAS wild-type metastatic colorectal cancer (mCRC), commonly used with folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI). In Iran, the rising burden of mCRC and the high cost of imported cetuximab underscore the urgent need for a cost-effective, locally manufactured biosimilar to improve treatment accessibility and sustainability within the healthcare system. The objective of this study is to compare the efficacy, safety, and immunogenicity of cetuximab (manufactured by CinnaGen Co.) versus reference cetuximab (Erbitux; manufactured by Merck) in patients with RAS wild-type mCRC. This phase III, double-blind, randomized, multi-center, active-controlled trial enrolled adult patients (n = 211) with RAS wild-type mCRC. Participants were allocated 2:1 to cetuximab (CinnaGen) plus FOLFIRI (n = 141) or Erbitux plus FOLFIRI (n = 70) for up to 48 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), safety, and immunogenicity. The results show that cetuximab (CinnaGen) was comparable to Erbitux for PFS in both PP (hazard ratio [HR] = 0.95; 90% confidence interval [CI]: 0.62–1.45) and ITT (HR = 0.82; 90% CI: 0.55–1.24) analyses, with upper CIs below the non-inferiority margin (1.51). No significant differences were observed in OS (HR = 0.85; 95% CI: 0.45–1.58), TTF (HR = 1.07; 95% CI: 0.77–1.48), or ORR (43.3% vs 45.7%; P-value = 0.77). The majority of patients experienced adverse events, with anemia, neutropenia, and hypomagnesemia being among the most frequently reported. The frequency of serious adverse events was considered clinically acceptable, and immunogenicity analyses revealed no detectable anti-cetuximab antibodies in either treatment group. In conclusion, this study demonstrated that cetuximab (CinnaGen) is non-inferior to Erbitux (Merck) in terms of PFS, with comparable efficacy across other endpoints. The safety profiles of both products were acceptable and consistent with known data for cetuximab-based regimens in mCRC.
Source: Scientific Reports
Authors: Hamid Rezvani, Alireza Rezvani, Abolghasem Allahyari, Mojtaba Ghadiany, Ali Esfahani, Seyed Mohammad Reza Mortazavizadeh, Valiollah Mehrzad, Nastaran Khodakarim, Mojtaba Gorji, Mehran Sharifi, Hadi Mohammad Doost, Mehran Hosseinzadeh, Aliraza Bari, Babak Nejati, Alireza Sadeghi, Seyed Hadi Chavoshi, Amirabbass Nekouee, Mohsen Razavi, Ali Hajigholami, Behjat Kalantari, Adnan Khosravi, Ali Darakhshandeh, Sajjad Ataei Azimi, Alireza Abrishami, Sahar Tavakkoli Shiraji, Araz Sabzvari, Sina Salari, Hamidreza Kafi
Institutions: Shahid Beheshti University, Shahid Beheshti University of Medical Sciences, Shiraz University, Shiraz University of Medical Sciences, Mashhad University of Medical Sciences, Tabriz University of Medical Sciences, Islamic Azad University, Yazd, Isfahan University of Medical Sciences, Iran University of Medical Sciences, Lorestan University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Milad Hospital, Kerman University of Medical Sciences, Masih Daneshvari Hospital, Hospital Labbafinejad, Tehran University of Medical Sciences, Alborz University of Medical Sciences, Taleghani General Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,690
OpenAlex ID: W7222289913
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