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    DRUG:

    Enweida (envafolimab)

    i
    Other names: KN035, KN 035, KN-035, ASC22, ASC-22, ASC 22
    Company:
    3DMed, Alphamab, Ascletis, Glenmark, Simcere
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    4d
    Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • etoposide oral • Enweida (envafolimab)
    6d
    Efficacy and safety of PD-L1 blockade envafolimab as neoadjuvant treatment in mismatch repair-deficient, locally advanced colorectal cancer: An open-label, single-arm study. (PubMed, Cancer)
    This preliminary study suggests that envafolimab is a promising effective and safe neoadjuvant option for locally advanced dMMR CRC; confirmation in larger cohorts is awaited.
    Journal • Mismatch repair • dMMR
    |
    PD-L1 (Programmed death ligand 1)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    7d
    Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=26, Recruiting, Shanghai Zhongshan Hospital
    New P2 trial
    |
    carboplatin • albumin-bound paclitaxel • Enweida (envafolimab)
    8d
    Rare MSI-H hepatoid adenocarcinoma of the colon with BRAF V600E mutation achieving long-term disease-free survival after adjuvant envafolimab: a case report. (PubMed, Front Immunol)
    Comprehensive molecular profiling can help guide personalized immunotherapy decisions. Further studies are needed to confirm long-term benefits, optimize treatment duration and dosing, and identify predictive biomarkers for high-risk CRC.
    Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
    |
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • PMS2 (PMS1 protein homolog 2)
    |
    BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600
    |
    Enweida (envafolimab)
    9d
    A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov)
    P1, N=57, Recruiting, Kangabio AUSTRALIA LTD PTY
    New P1 trial
    |
    Enweida (envafolimab)
    11d
    A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    Lenvima (lenvatinib) • Enweida (envafolimab)
    18d
    Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    ifosfamide • Enweida (envafolimab)
    2ms
    Efficacy, safety, and exploratory biomarker analysis of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: a prospective, single-arm, phase II trial. (PubMed, BMC Med)
    Envafolimab combined with chemotherapy as a first-line treatment for ES-SCLC yielded favorable clinical efficacy with a manageable safety profile, indicating that it may be a promising treatment modality.
    P2 data • Journal
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL3 (C-C Motif Chemokine Ligand 3)
    |
    carboplatin • etoposide IV • Enweida (envafolimab)
    3ms
    Immune activation following PD-L1 inhibitor plus chemoradiotherapy in locally advanced rectal cancer: a retrospective, single-arm study. (PubMed, Front Immunol)
    In this retrospective, single-arm design study, 36 LARC patients (T3+/N1-2/M0) received long-course radiotherapy (50.4 Gy/28 fractions) with capecitabine, followed by two cycles of XELOX chemotherapy and envafolimab...This approach enhances cytotoxic immunity while addressing immunosuppressive barriers. Further studies should explore strategies to overcome TME resistance.
    Retrospective data • Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
    |
    capecitabine • oxaliplatin • Enweida (envafolimab)
    3ms
    Intelligent bacterial platform induces programmed death-ligand 1 lysosomal degradation to enhance antitumor immunity. (PubMed, Int J Biol Macromol)
    This process effectively alleviates immunosuppression in the TME and enhances the activation and proliferation of tumor-specific T cells. Experimental results demonstrated that CXCL12-KN035-expressing bacteria significantly inhibit tumor growth and metastasis through the synergistic action of the chemokine and nanobody, establishing a novel degradation-centric paradigm for bacteria-mediated tumor therapy beyond transient blockade.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • ACKR3 (Atypical Chemokine Receptor 3)
    |
    Enweida (envafolimab)
    4ms
    Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    New P2 trial
    |
    cisplatin • doxorubicin hydrochloride • Enweida (envafolimab)
    4ms
    Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer (ChiCTR2500106258)
    P2, N=43, Recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
    |
    capecitabine • Enweida (envafolimab)