Overview
Panitumumab (ABX-EGF) is a recombinant human IgG2 monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). This drug is an antineoplastic agent. Panitumumab was granted FDA approval on 27 September 2006.
Indication
美国FDA批准:用于野生型KRAS(外显子2)转移性结直肠癌(mCRC)患者的一线治疗。
Associated Conditions
- Metastatic Colorectal Cancer (CRC)
Research Report
Panitumumab (Vectibix®): A Comprehensive Monograph on a Targeted Therapy for Metastatic Colorectal Cancer
Executive Summary and Key Findings
Panitumumab, marketed under the brand name Vectibix®, is a cornerstone of targeted therapy for metastatic colorectal cancer (mCRC). It is a recombinant, fully human IgG2 kappa monoclonal antibody that functions as a high-affinity antagonist of the human epidermal growth factor receptor (EGFR).[1] By competitively inhibiting the binding of endogenous ligands like EGF and TGF-α, panitumumab blocks the downstream signaling cascades—primarily the RAS-RAF-MEK-ERK and PI3K-AKT-mTOR pathways—that drive tumor cell proliferation, survival, and angiogenesis.[3] Its efficacy is critically dependent on the molecular profile of the tumor. The paramount finding from over a decade of clinical research is that panitumumab provides benefit exclusively to patients with wild-type
RAS (both KRAS and NRAS) tumors, and its use in RAS-mutant disease is associated with a lack of benefit and potential harm.[5]
Pivotal clinical trials have precisely defined its role in the mCRC treatment algorithm. The PRIME study established its efficacy in the first-line setting in combination with FOLFOX chemotherapy for RAS wild-type patients, demonstrating significant improvements in both progression-free survival (PFS) and overall survival (OS).[7] The ASPECCT trial confirmed its non-inferiority to the chimeric anti-EGFR antibody cetuximab in the chemorefractory setting, establishing it as a valid therapeutic alternative.[9] More recently, the PARADIGM trial provided practice-changing evidence that for patients with left-sided,
RAS wild-type tumors, first-line treatment with panitumumab plus FOLFOX is superior to bevacizumab plus FOLFOX in extending overall survival, solidifying primary tumor location as a key predictive biomarker.[11] In a strategic reversal of its contraindication in
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2009/07/07 | Phase 2 | Completed | Centre Jean Perrin | ||
2009/05/07 | Phase 2 | Completed | |||
2009/04/10 | Phase 1 | Completed | |||
2009/03/13 | Phase 2 | Completed | |||
2009/03/02 | Not Applicable | Completed | |||
2009/02/12 | Phase 2 | Completed | |||
2009/02/04 | Phase 2 | Completed | Weijing Sun, MD, FACP | ||
2009/01/19 | Phase 3 | Terminated | |||
2009/01/09 | Phase 2 | Completed | |||
2008/11/26 | Phase 2 | Completed | Robert Ferris |
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