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    DRUG CLASS:

    EGFR antagonist

    Related drugs:
    24d
    Immunotherapeutic strategies in HPV-positive and HPV-negative recurrent/metastatic oropharyngeal squamous cell carcinoma: from PD-1 blockade to EGFR-directed bispecifics and therapeutic HPV vaccines. (PubMed, Crit Rev Oncol Hematol)
    Emerging agents such as ficerafusp alfa, petosemtamab, and amivantamab have demonstrated promising early clinical activity, particularly in biomarker-enriched or post-immunotherapy settings. In HPV-positive disease, therapeutic vaccines targeting E6/E7 oncoproteins have shown encouraging immunogenicity and preliminary antitumor activity, especially when combined with PD-1 blockade. Overall, the immunotherapeutic landscape of OPSCC is evolving toward a biomarker-driven framework integrating viral status, immune contexture and pathway activation to enable more precise and personalized treatment strategies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • TGFB1 (Transforming Growth Factor Beta 1)
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    ficerafusp alfa (BCA101) • petosemtamab (MCLA-158)
    29d
    KL140-I-01-CTP: Safety and Pharmacokinetics of Recombinant Anti-EGFr Antibody in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=18, Completed, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Unknown status --> Completed
    Trial completion
    |
    Erbitux (cetuximab) • Datalai (cetuximab biosimilar)
    29d
    FALCO: Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases (clinicaltrials.gov)
    P2, N=40, Recruiting, Zhejiang University
    New P2 trial
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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    KRAS mutation • KRAS G12C • BRAF mutation • NRAS mutation • BRAF wild-type • KRAS G12 • NRAS wild-type • NRAS G12
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    Erbitux (cetuximab) • Dupert (fulzerasib) • Datalai (cetuximab biosimilar)
    30d
    KL140-III-01: Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial (clinicaltrials.gov)
    P3, N=52, Terminated, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | N=570 --> 52 | Recruiting --> Terminated; Due to adjustments in our R&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.
    Enrollment change • Trial termination
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    BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
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    BRAF V600E • BRAF V600 • BRAF wild-type • RAS wild-type • BRAF V600 wild-type
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    oxaliplatin • leucovorin calcium • Datalai (cetuximab biosimilar)
    1m
    MCLA-158-CL04: A Phase 2 Study of Petosemtamab in Combination with Pembrolizumab in Adults with NSCLC (2025-522867-13-00)
    P1/2, N=90, Recruiting, Merus B.V. | N=45 --> 90
    Enrollment change
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    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)
    1m
    MCLA-158-CL04: A Phase 2 Study of Petosemtamab in Combination with Pembrolizumab in Adults with NSCLC (2025-522867-13-00)
    P1/2, N=90, Recruiting, Merus B.V. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)
    2ms
    LiGeR-HN1: A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1) (clinicaltrials.gov)
    P3, N=700, Recruiting, Merus B.V. | N=500 --> 700
    Enrollment change
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    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)
    2ms
    MCLA-158-CL04: A Phase 2 Study of Petosemtamab in Combination with Pembrolizumab in Adults with NSCLC (2025-522867-13-00)
    P1/2, N=45, Not yet recruiting, Merus N.V.
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)
    2ms
    Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Merus B.V. | Initiation date: Dec 2025 --> Mar 2025
    Trial initiation date
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    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)
    2ms
    Rezivertinib in EGFR-Mutated Non-Small Cell Lung Cancer Patients with Central Nervous System Metastasis: Central Nervous System Efficacy from the Phase III REZOR Study. (PubMed, Cancer Commun (Lond))
    Patients were randomly assigned 1:1 to receive either rezivertinib (180 mg/d) plus gefitinib placebo or gefitinib (250 mg/d) plus rezivertinib placebo. The safety profile was consistent with previous analyses. Trial registration: NCT03866499 (ClinicalTrials.gov).
    Clinical • P3 data • Journal
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    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET mutation
    |
    gefitinib • Rui Bi Da (rezivertinib)
    4ms
    Cost-effectiveness analysis of rezivertinib and gefitinib in patients with EGFR-mutated advanced non-small cell lung cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res)
    Threshold analysis established cost-effective pricing thresholds for rezivertinib ($605.02 at 3×GDP per capita, $408.66 at 1.5×GDP per capita). Rezivertinib demonstrates significantly better cost-effectiveness compared to gefitinib for first-line treatment of EGFR-mutated advanced NSCLC in China.
    Journal • HEOR • Cost-effectiveness
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    gefitinib • Rui Bi Da (rezivertinib)
    5ms
    Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Merus N.V.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • petosemtamab (MCLA-158)