^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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:
    12d
    Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=15, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Trial completion date: Sep 2027 --> Jun 2027 | Initiation date: Dec 2025 --> Sep 2025
    Enrollment open • Trial completion date • Trial initiation date
    |
    ifosfamide • Enweida (envafolimab)
    18d
    A high-throughput selection system for fast-acting covalent protein drugs. (PubMed, Science)
    Using this system, we engineered a covalent programmed death-ligand 1 (PD-L1) antagonistic nanobody with rapid crosslinking kinetics (kobs = 0.18 min-1, t1/2 = 3.8 min) and improved tumor suppression compared with envafolimab and atezolizumab. Similarly, we engineered a fast-acting covalent interleukin-18 (IL-18) (kobs = 0.54 min-1, t1/2 = 1.3 min) and a covalent miniprotein targeting the receptor binding domain (RBD) of SARS-CoV-2, demonstrating applicability across protein modalities.
    Journal
    |
    PD-L1 (Programmed death ligand 1) • IL18 (Interleukin 18)
    |
    Tecentriq (atezolizumab) • Enweida (envafolimab)
    23d
    Envafolimab combined with chemotherapy in advanced thymic carcinoma - first clinical experience with a novel subcutaneous programmed death-ligand 1 inhibitor. (PubMed, Anticancer Drugs)
    We report two cases of advanced thymic carcinoma treated with the programmed death-ligand 1 inhibitor envafolimab with chemotherapy (liposomal paclitaxel and cisplatin)...Both patients achieved PFS (6 and 9 months, respectively) that exceeded the median PFS reported in previous clinical studies using chemotherapy alone (5 months). This combination warrants further investigation in clinical trials.
    Journal • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    paclitaxel • Enweida (envafolimab)
    24d
    Efficacy and Safety of Envafolimab Combined With Capecitabine and Lenvatinib as Postoperative Adjuvant Therapy in Resected Biliary Tract Cancer With High-Risk Recurrence Factors: A Phase II Single-Center Prospective Study. (PubMed, Cancer Med)
    The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high-risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials.
    P2 data • Journal
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Lenvima (lenvatinib) • capecitabine • Enweida (envafolimab)
    26d
    Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer (clinicaltrials.gov)
    P2, N=108, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Lenvima (lenvatinib) • Enweida (envafolimab)
    26d
    KN035-CN-017: Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC (clinicaltrials.gov)
    P3, N=390, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab)
    26d
    KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date • MSI-H • dMMR
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    26d
    Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Jun 2027 --> Dec 2029 | Trial primary completion date: Jun 2026 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • Enweida (envafolimab)
    26d
    Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors (clinicaltrials.gov)
    P1/2, N=170, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    sunitinib • Lenvima (lenvatinib) • Enweida (envafolimab)
    2ms
    A Preclinical Study of [64Cu]Cu-NOTA-KN035 for Molecular Imaging of PD-L1 in Tumors. (PubMed, Mol Pharm)
    Tumor uptake decreased significantly after blocking with excess KN035, confirming the specificity. These results demonstrate the high PD-L1-targeting specificity of [64Cu]Cu-NOTA-KN035, suggesting its great potential as a noninvasive diagnostic tool for immunotherapy-based treatments in the future.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Enweida (envafolimab)
    2ms
    Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. (clinicaltrials.gov)
    P2, N=30, Recruiting, Chongqing University Cancer Hospital | N=45 --> 30 | Trial completion date: Oct 2027 --> Feb 2027 | Trial primary completion date: Oct 2027 --> Feb 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    MSI-H/dMMR
    |
    cisplatin • Enweida (envafolimab)
    2ms
    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 | Trial completion date: Dec 2025 --> May 2026
    Trial completion date
    |
    Focus V (anlotinib) • etoposide oral • Enweida (envafolimab)