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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
    MT3-KN035 Nanoparticles Based on PD-L1 Nanobodies Allow for Multiple Drug Conjugations that Promote Chemo- and Immunosynergistic Therapies. (PubMed, ACS Biomater Sci Eng)
    Meanwhile, MT3-KN035 conjugated multiple aldoxorubicin (hereafter, these conjugates are referred to as MT3-KN035-DOX) via an acidic cleavable linker; MT3-KN035-DOXHigh induced tumor apoptosis and exhibited significant antitumor efficacy via facilitating immune cell infiltrations. This work provides a novel therapeutic strategy via nanobody-mediated target engagement and internalization that achieves synergistic therapeutic efficacy between chemotherapy and immune checkpoint blockade therapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab) • aldoxorubicin (INNO-206)
    11d
    Severe renal toxicity following adjuvant envafolimab in a patient with ultra-hypermutated (POLE) stage II colorectal cancer: a case report. (PubMed, AME Case Rep)
    For early-stage POLE-mutated CRC with favorable prognosis, off-label adjuvant immunotherapy may bring unnecessary toxicity risks. It is necessary to conduct rigorous patient selection, comprehensive risk-benefit evaluation, and close monitoring of organ function during treatment, so as to provide reference for the standardized clinical application of ICIs in this population.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • POLE (DNA Polymerase Epsilon)
    |
    BRAF V600E • KRAS mutation • TMB-H • BRAF V600 • POLE mutation
    |
    Enweida (envafolimab)
    18d
    Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=20, Recruiting, West China Hospital
    New P1/2 trial
    |
    Lenvima (lenvatinib) • Enweida (envafolimab)
    28d
    First-line envafolimab plus recombinant human-endostatin in advanced non-small cell lung cancer with PD-L1 tumor proportion score ≥1% (Endouble): A multicenter, prospective, single-arm, phase 2 trial. (PubMed, Cancer)
    Envafolimab combined with Rh-endostatin demonstrated favorable efficacy and tolerable toxicity in patients with PD-L1-positive, advanced driver-gene negative NSCLC.
    P2 data • Journal • Tumor proportion score • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • MMP1 (Matrix metallopeptidase 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab) • Endostar (recombinant human endostatin)
    1m
    Overcoming Acquired MET-Driven Resistance to First-Line Lorlatinib: Successful Combination of Lorlatinib and Envafolimab in an ALK-Positive NSCLC Patient with Ultra-High PD-L1 Expression. (PubMed, Curr Oncol)
    Herein, we report a case of an elderly patient with ALK-rearrangement and exceptionally high PD-L1 expression (TPS ≥ 95%) NSCLC who experienced disease progression following first-line lorlatinib with genetically confirmed MET amplification. The patient subsequently received an exploratory combination of continued lorlatinib plus envafolimab and achieved partial response (PR) with manageable tolerability after 4 months, highlighting a potential sequential strategy that may warrant further investigation in select ALK-positive NSCLC patients exhibiting both bypass pathway activation and exceptionally high PD-L1 expression.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    PD-L1 expression • PD-L1 overexpression • ALK positive • MET amplification • ALK rearrangement
    |
    Lorbrena (lorlatinib) • Enweida (envafolimab)
    1m
    GENE: Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Sir Run Run Shaw Hospital
    New P2 trial
    |
    cisplatin • gemcitabine • Enweida (envafolimab)
    1m
    A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=20, Suspended, Shanghai 6th People's Hospital | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial suspension • Trial primary completion date
    |
    Fruzaqla (fruquintinib) • Enweida (envafolimab)
    2ms
    Neoadjuvant Treatment For Locally Advanced Thymic Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Enweida (envafolimab)
    2ms
    ENCOMPASS STUD: Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program (clinicaltrials.gov)
    P=N/A, N=120, Not yet recruiting, IR INNOVATE RESEARCH PRIVATE LIMITED
    New trial • Real-world evidence
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    2ms
    This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Kangabio AUSTRALIA LTD PTY | Trial completion date: May 2026 --> May 2028
    Trial completion date • First-in-human
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab)
    2ms
    Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | N=15 --> 25 | Initiation date: Sep 2025 --> Sep 2024
    Enrollment change • Trial initiation date
    |
    ifosfamide • Enweida (envafolimab)