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cetuximab (Lupitux / Cetuxa / ENZ124)

✓ Approved

Lupin Limited · EGFR · 单克隆抗体

什么是 cetuximab？

cetuximab 是一种单克隆抗体，由Lupin Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名Lupitux, Cetuxa, ENZ124
公司Lupin Limited
药物类别单克隆抗体, 抗体
分子靶点EGFR
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Lupin Limited

作用机制

分子靶点

cetuximab 作用于 1 个分子靶点：

EGFRepidermal growth factor receptor (ERBB1, NNCIS)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

cetuximab 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Head and neck cancer metastatic✓ Approved

相关研究文献

PubMedOral oncology2026-06-12

Intravenous amivantamab after cetuximab failure in recurrent or metastatic head and neck squamous cell carcinoma: a single-centre retrospective real-world cohort study.

Xue Liqiong L, Zhou Jiuli J, Tang Wenbo W, Zhao Wei W et al.

Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who exhaust platinum, immune checkpoint inhibitors (ICIs), and cetuximab lack standard options. The OrigAMI-4 trial showed subcutaneous amivantamab activity in anti-EGFR-naïve patients; real-world intravenous (IV) amivantamab data after cetuximab failure are absent. We retrospectively analysed consecutive R/M HNSCC patients treated with IV amivantamab monotherapy (November 2024-July 2025) after progression on standard therapies. Response was assessed per RECIST 1.1; toxicity per CTCAE v5.0. Twenty patients were included (median age 54 years; 70.0% male; median four prior systemic lines). All received prior platinum and ICIs; 18 (90.0%) progressed on cetuximab. At a median follow-up of 6.8 months, confirmed ORR was 30.0% (6/20; 95% CI 11.9-54.3) ; DCR at first reassessment (6 weeks) was 80.0% (16/20; 95% CI 56.3-94.3) and confirmed DCR at 12 weeks was 45.0% (9/20; 95% CI 23.1-68.5). Median PFS was 3.0 months (95% CI 2.3 to not reached) and median OS 9.7 months (95% CI 6.8 to not reached). The most frequent treatment-related adverse events were hypoalbuminaemia (90.0%), rash (70.0%), and infusion-related reactions (45.0%; all grade 1-2); two patients had grade 3 events, none discontinued treatment. In this small retrospective cohort, IV amivantamab showed antitumour activity in heavily pretreated, cetuximab-exposed R/M HNSCC, with a 30% confirmed ORR, 45% confirmed 12-week DCR, 9.7-month median OS, and no treatment discontinuations for toxicity. These data suggest that dual EGFR-MET targeting may retain clinical utility after anti-EGFR failure, and support prospective evaluation with biomarker stratification.

PMID 42284626
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PubMedCancers2026-06-12

Biomarker-Stratified Efficacy of Immune Checkpoint Inhibitors in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Randomized Trials.

Srinivasmurthy Ramaditya R, Jones Daniel T DT, Nanda Rishi K RK, Ta Jason J et al.

Introduction: The role of immune checkpoint inhibitors (ICIs) in locally advanced head and neck squamous cell carcinoma (LA HNSCC) remains uncertain, with randomized trials showing inconsistent results in heterogeneous populations. We conducted a systematic review of randomized trials evaluating ICI-based strategies in LA HNSCC, with outcomes stratified by PD-L1 expression, HPV/p16 status, and cisplatin eligibility to identify patient subgroups most likely to benefit from ICIs. Methods: MEDLINE, Cochrane, and EMBASE databases were systematically searched up to 10 January 2026. Randomized controlled trials (RCTs) evaluating ICIs in patients with LA HNSCC were included. The primary outcome was pooled time-to-event efficacy, including event-free survival (EFS), progression-free survival (PFS), and disease-free survival (DFS) as reported across trials. A generic inverse variance method was used to calculate the estimated pooled hazard ratio (HR) for PFS with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q test. Random effects model was applied. Results: A total of 3605 patients from seven phase II/III RCTs were included. In the overall population, no significant difference in EFS/PFS/DFS was observed between ICI and standard therapy (HR 0.90; 95% CI: 0.77-1.06; p = 0.20). However, in subgroup analyses stratified by PD-L1 expression, patients with PD-L1-positive tumors demonstrated improved PFS with ICIs compared with control (HR 0.78; 95% CI: 0.67-0.91; p < 0.0001). In contrast, PD-L1-negative tumors demonstrated inferior PFS in the ICIs arm (HR 1.31; 95% CI: 1.02-1.68; p = 0.03). No significant differences in PFS were observed based on HPV or p16 status. A subset analysis of cisplatin-eligible LA HNSCC trials evaluating the addition of ICIs to standard therapy showed a similar pattern. ICI use in PD-L1-positive patients demonstrated significantly improved PFS (HR 0.76; 95% CI: 0.63-0.92; p < 0.0001), while ICI use in PD-L1-negative patients demonstrated decreased PFS (HR 1.28; 95% CI: 0.99-1.66; p = 0.06). In cisplatin-ineligible populations, ICI regimens did not improve PFS compared with cetuximab plus RT. Conclusions: This study showed that although in the overall population there was no significant difference in EFS/PFS/DFS, in the PD-L1-positive subgroup, patients experienced significantly improved PFS with ICIs compared with control, while in the PD-L1-negative subgroup, patients demonstrated inferior PFS in the ICIs arm; these results were mirrored in the cisplatin-eligible subgroup.

PMID 42279263
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PubMedClinical oncology (Royal College of Radiologists (Great Britain))2026-06-11

Survival and Toxicity in Elderly Patients Treated With Chemoradiotherapy for Head and Neck Cancer: A Retrospective Study at a Large Quaternary Centre.

Sekar P P, Goetz J J, Ng G G, Nottage M M et al.

Limited evidence supports the benefit of chemoradiotherapy for locally advanced head and neck cancer (LA-HNSCC) in elderly patients. Further evidence is needed to support the use of combined modality approaches in elderly patients. We performed a single-institution retrospective review of elderly patients treated with chemoradiotherapy for LA-HNSCC. Patients >70 years of age who received cisplatin or cetuximab alongside radiotherapy for LA-HNSCC in the definitive or adjuvant setting between the sampled years of 2017 and 2020 were included. Primary outcomes were overall survival (OS) and progression-free survival (PFS) in the total population and within the cisplatin and cetuximab groups. Secondary outcomes were OS by cumulative dose of cisplatin received and p16 status along with toxicity outcomes. Univariate regression was performed for survival analyses and cox proportional hazards regression models estimated the hazard ratios (HRs). Multivariable regression estimated the HR associated with cisplatin vs cetuximab, adjusted for variables of age, functional status and comorbidities. One hundred eleven elderly patients received adjuvant and definitive chemoradiotherapy (94 definitive and 17 adjuvant). The 5-year OS estimate was 59% for all patients and the 5-year PFS was 52% for all patients. The 5-year OS estimate was 66% for cisplatin and 45% for cetuximab (HR: 0.53, P = .02). The 5-year PFS estimate was 60% for cisplatin and 32% for the cetuximab cohort (HR 0.28, P = 0.001). 5-year OS estimate was 68% for cisplatin cumulative dose ≥200mg/m2 and 59% for patients who received <200mg/m2 of cisplatin (HR 0.58, P = 0.20). After multivariate analysis, the HR for OS was 0.95 (P = 0.90) for cisplatin vs cetuximab. Grade 3-4 toxicities occurred in 38% and 64% of the cisplatin and cetuximab cohorts, respectively. Carefully selected robust elderly patients with LA-HNSCC treated with chemoradiotherapy have outcomes comparable to younger patients after locally advanced head and neck cancer treatment.

PMID 42275728
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PubMedJournal of biological engineering2026-06-09

Engineering a conditionally active cetuximab prodrug via affibody-based paratope masking.

Mestre Borras Anna A, Mehari Hanna H, Bitzios Athanasios A, Zelepukin Ivan I et al.

The application of monoclonal antibodies as targeted drugs has revolutionized cancer therapy, yet their efficacy is sometimes limited by toxicities arising from target expression in healthy tissues. Various strategies have emerged to overcome these issues, including the design of antibody-based prodrugs. Here, we report the generation of affibody-based masking domains designed to specifically bind and mask the paratope of the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab. Bacterial display of affibody library and cell sorting were employed to isolate suitable candidates. Both experimental and computational analyses confirmed that several of these selected affibodies effectively blocked cetuximab from binding EGFR. A cetuximab prodrug was created by fusing the most promising masking candidate to the antibody heavy chains. The prodrug demonstrated over 400-fold difference in growth inhibition effect between its masked and unmasked states in vitro. A biodistribution study comparing cetuximab and its prodrug demonstrated the feasibility of conditional activation of the cetuximab prodrug in a xenograft mouse model. This study is the first to describe the use of an affibody masking domain to create an antibody-based prodrug, demonstrating significant potential for further development of safer and more efficacious cancer therapies.

PMID 42260612
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PubMedSignal transduction and targeted therapy2026-06-09

Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study.

Guo Ye Y, Li Zhendong Z, Xue Liqiong L, Lin Jinguan J et al.

This open-label, multicenter, phase 1b/2 trial assessed the safety and efficacy of toripalimab plus cetuximab in patients with platinum-refractory (Cohort A) or previously untreated programmed cell death-ligand 1 (PD-L1)-positive (Cohort B) recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Patients received toripalimab 240 mg intravenously (IV) every 3 weeks and cetuximab (400 mg/m² loading, then 250 mg/m² weekly maintenance). Primary endpoints were safety in phase 1b and objective response rate (ORR) as assessed by the Independent Review Committee (Cohort A) and investigator (Cohort B) in phase 2. Secondary efficacy endpoints included progression-free survival (PFS) and overall survival (OS). By October 25, 2024, 88 patients were enrolled (Cohort A: 45; cohort B: 43). In Cohort A, confirmed ORR was 60.0% (95% confidence interval [CI]: 44.3%, 74.3%), median PFS was 9.9 months (95% CI: 4.2, 19.4), and median OS was 14.1 months (95% CI: 8.5, 17.7). PD-L1-positive (combined positive score [CPS] ≥1) patients appeared to benefit more than PD-L1-negative (CPS < 1) patients (ORR: 64.5% vs. 40.0%, median PFS: 10.4 vs. 4.0 months, median OS: 15.4 vs. 13.3 months). In Cohort B, confirmed ORR was 44.2% (95% CI: 29.1%, 60.1%), median PFS was 8.2 months (95% CI: 4.2, 17.1), and median OS was 18.1 months (95% CI: 10.6, inestimable). Grade ≥3 treatment-emergent adverse events occurred in 53.3% (Cohort A) and 51.2% (Cohort B) of the patients in phase 2. No novel safety signals were identified. Toripalimab combined with cetuximab demonstrated manageable safety and promising efficacy for R/M HNSCC, warranting further investigation. Clinical trial number: NCT04856631.

PMID 42260304
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PubMedEuropean journal of cancer (Oxford, England : 1990)2026-06-09

European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment - update 2026.

Stratigos Alexander J AJ, Dessinioti Clio C, Garbe Claus C, Lebbe Celeste C et al.

Part 2 of the guideline addresses the updates on treatment recommendations in immunocompetent as well as immunosuppressed patients with invasive cutaneous squamous cell carcinoma (CSCC), based on current literature and expert consensus. A multidisciplinary panel of experts from the European Association of Dermato-Oncology (EADO), the European Dermatology Forum (EDF), the European Society for Radiotherapy and Oncology (ESTRO), the European Union of Medical Specialists (UEMS)-Dermatology Venereology and the European Organization of Research and Treatment of Cancer (EORTC), was formed to update the previous guideline on CSCC (version 2023). For common primary CSCC, first-line treatment is surgical excision with post-operative margin assessment or micrographically controlled surgery. Achieving clear histological margins is key for patients with CSCC amenable to surgery. Radiotherapy should be considered for non-surgical candidates/tumors. For patients with macroscopic regional lymph node metastases, individualized treatment should be discussed in the multidisciplinary tumor board. For patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiotherapy, anti-PD-1 agents are the first-line systemic treatment, with cemiplimab being the approved systemic agent for advanced CSCC by the EMA. Second-line systemic treatments for advanced CSCC, include clinical trials, EGFR inhibitors (cetuximab) combined with anti-PD-1 immunotherapy, or chemotherapy or radiotherapy. The decision for adjuvant cemiplimab for CSCC at high risk of recurrence after surgery and radiotherapy should be discussed in the multidisciplinary tumor board. In addition, multidisciplinary board decisions are mandatory for all patients with advanced CSCC, considering the risks of toxicity, the age and frailty of patients and co-morbidities, including immunosuppression. Patients should be engaged in informed, shared decision-making on management and be provided with best supportive care to improve symptom management and quality of life. Frequency of follow-up visits and investigations for subsequent new CSCC depend on underlying risk characteristics.

PMID 42263355
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