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    DRUG:

    Enweida (envafolimab)

    i
    Other names: KN 035, KN-035, ASC22, ASC-22, ASC 22, KN035
    Company:
    3DMed, Alphamab, Ascletis, Glenmark, Simcere
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    10d
    neovision: Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, Guangdong Provincial People's Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    PD-L1 expression • HER-2 expression
    |
    carboplatin • Aidixi (disitamab vedotin) • Enweida (envafolimab)
    23d
    A Case Report of Envafolimab in the Treatment of Microsatellite Stable (MSS) Metastatic Colon Cancer. (PubMed, Onco Targets Ther)
    The current efficacy evaluation was the partial response (PR), and the overall survival (OS) was more than 12 months. Considering the safety and efficacy of Envafolimab observed in our case, we believe that Envafolimab may be a promising drug for the treatment of MSS metastatic colon cancer.
    Journal • Metastases
    |
    MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    24d
    ASC-ASC22-II-CTP-01: A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients (clinicaltrials.gov)
    P2, N=207, Completed, Ascletis Pharmaceuticals Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    Enweida (envafolimab)
    27d
    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: Oct 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Lenvima (lenvatinib) • Enweida (envafolimab)
    1m
    Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV (clinicaltrials.gov)
    P2, N=19, Completed, Ascletis Pharmaceuticals Co., Ltd. | Recruiting --> Completed | N=30 --> 19 | Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Dec 2023 --> May 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Enweida (envafolimab)
    1m
    Case report: Combination therapy of envafolimab with endostar for advanced non-small cell lung cancer with low PD-L1 expression. (PubMed, Front Oncol)
    This case demonstrates the efficacy of envafolimab combined with endostar in the treatment of advanced NSCLC. This regimen enhances treatment safety and patient compliance, potentially offering a novel therapeutic option for patients with advanced NSCLC characterized by low PD-L1 expression and negative driver gene mutations.
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab) • Endostar (recombinant human endostatin)
    1m
    Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin (clinicaltrials.gov)
    P2, N=52, Recruiting, Shanghai Chest Hospital
    New P2 trial • Combination therapy
    |
    carboplatin • etoposide IV • Enweida (envafolimab) • Cosela (trilaciclib)
    1m
    SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Peking University Shenzhen Hospital
    New P2 trial
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Imfinzi (durvalumab) • gemcitabine • Rozlytrek (entrectinib) • imatinib • 5-fluorouracil • Tyvyt (sintilimab) • Alecensa (alectinib) • Nerlynx (neratinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Irene (pyrotinib) • Balversa (erdafitinib) • albumin-bound paclitaxel • irinotecan • Orpathys (savolitinib) • epirubicin • vinorelbine tartrate • Partruvix (pamiparib) • Epkinly (epcoritamab-bysp) • Hetronifly (serplulimab) • Enweida (envafolimab) • Vumon (teniposide) • Ariely (adebrelimab)
    2ms
    RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure (clinicaltrials.gov)
    P1/2, N=72, Recruiting, Tianjin Medical University Second Hospital
    New P1/2 trial • Metastases
    |
    Aidixi (disitamab vedotin) • Enweida (envafolimab)
    2ms
    Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Sulanda (surufatinib) • Enweida (envafolimab)
    2ms
    D-TACE-HAIC Combined With Envafolimab and Lenvatinib in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: a Prospective, Single-arm, Phase II Clinical Study (clinicaltrials.gov)
    P=N/A, N=37, Recruiting, Fujian Provincial Hospital
    New trial • Surgery
    |
    Lenvima (lenvatinib) • Enweida (envafolimab)
    3ms
    Local Injection and Systemic Therapy in the Treatment of NSCLC. (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Henan Cancer Hospital
    New P2 trial
    |
    docetaxel • Enweida (envafolimab) • Endostar (recombinant human endostatin)
    3ms
    β-glucan combined with Envafolimab and Endostar as immune rechallenge for metastatic non-small cell lung cancer. (PubMed, BMC Immunol)
    β-glucan combined with Envafolimab and Endostar has considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients who failed of anti-PD-1 treatment previously, especially for PD-L1 positive patients.
    Clinical • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CASP8 (Caspase 8) • ARG1 (Arginase 1) • CD40LG (CD40 ligand) • CXCL5 (Chemokine (C-X-C motif) ligand 5)
    |
    PD-L1 expression
    |
    Enweida (envafolimab) • Endostar (recombinant human endostatin)
    4ms
    Neoadjuvant envafolimab in a patient with MSI-H/dMMR colon cancer: a case report and literature review. (PubMed, Immunotherapy)
    Tumor regression was achieved after seven cycles of envafolimab treatment, and the patient obtained postoperative pathological complete response (pCR). Here, we report a case of MSI-H/dMMR transverse colon cancer, who obtained pCR after neoadjuvant envafolimab (a novel subcutaneous single-domain anti-PD-L1 antibody) with a favorable safety profile, aiming to enhance the experiences of comprehensive diagnosis and treatment of colon cancer.
    Review • Journal
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    4ms
    KN035-BTC: Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (clinicaltrials.gov)
    P3, N=480, Active, not recruiting, 3D Medicines (Sichuan) Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Jan 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    gemcitabine • oxaliplatin • Enweida (envafolimab)
    4ms
    KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    Enweida (envafolimab)
    4ms
    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 completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    sunitinib • Lenvima (lenvatinib) • Enweida (envafolimab)
    4ms
    Phase I Trial of Envafolimab for Healthy Male Subjects (clinicaltrials.gov)
    P1, N=160, Completed, 3D Medicines (Sichuan) Co., Ltd. | Recruiting --> Completed | Trial completion date: Mar 2024 --> Nov 2023
    Trial completion • Trial completion date
    |
    Enweida (envafolimab)
    5ms
    Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC. (clinicaltrials.gov)
    P2, N=34, Completed, Chipscreen Biosciences, Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> May 2024
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    Epidaza (chidamide) • Enweida (envafolimab)
    5ms
    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, Recruiting, Kangabio AUSTRALIA LTD PTY | Not yet recruiting --> Recruiting | N=27 --> 54 | Trial completion date: Sep 2026 --> May 2026 | Trial primary completion date: Jan 2026 --> May 2026
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Enweida (envafolimab)
    5ms
    Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. (clinicaltrials.gov)
    P2, N=45, Recruiting, Chongqing University Cancer Hospital | Not yet recruiting --> Recruiting | N=30 --> 45 | Initiation date: Oct 2023 --> Aug 2024
    Enrollment open • Enrollment change • Trial initiation date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • Enweida (envafolimab)
    5ms
    Envafolimab Inhibits the Growth of Gastric Cancer Cells with Low PD-L1 Expression through the DDX20/NF-κB/TNF-α Signaling Pathway. (PubMed, Curr Cancer Drug Targets)
    This study confirmed that envafolimab could inhibit the growth of gastric cancer cells with low PD-L1 expression by down-regulating DDX20 expression and regulating the NFκB/TNF-α signaling pathway.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    Enweida (envafolimab)
    5ms
    Envafolimab combined with Irinotecan or albumin-paclitaxel and Chidamide as second-line therapy in advanced and metastatic gastric cancer: A single-arm, exploratory, phase 2 trial (ChiCTR2400080485)
    P=N/A, N=30, Recruiting, First affiliated hospital of Soochow university; First affiliated hospital of Soochow university
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    albumin-bound paclitaxel • irinotecan • Epidaza (chidamide) • Enweida (envafolimab)
    6ms
    Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab (clinicaltrials.gov)
    P2, N=45, Recruiting, Anhui Provincial Hospital
    New P2 trial • Combination therapy • Surgery
    |
    Enweida (envafolimab) • Zepsun (donafenib)
    6ms
    Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. (PubMed, Oncologist)
    No statistically significant difference was observed between weight-based and fixed dose regimens. Model-based simulation supports the adoption of a 150 mg weekly or 300 mg biweekly dosing regimen of envafolimab in the solid tumor population, as these schedules effectively balance survival benefits and safety risks.
    Journal • Metastases
    |
    MSI (Microsatellite instability)
    |
    oxaliplatin • irinotecan • Enweida (envafolimab)
    7ms
    Genetically Encoded Epoxide Warhead for Precise and Versatile Covalent Targeting of Proteins. (PubMed, J Am Chem Soc)
    Our study demonstrates that EPOY, when incorporated into a nanobody (KN035), can cross-link with different side chains (mutations) at the same position of PD-L1 protein...This covalent KRAS binder holds the potential to achieve pan-covalent targeting of KRAS based on the structural similarity among all oncogenic KRAS mutants while avoiding off-target binding to NRAS/HRAS through a covalent interaction with KRAS-specific residues (H95 and E107). We envision that covalently targeting to H95 will be a promising strategy for the development of covalent pan-KRAS inhibitors in the future.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    Enweida (envafolimab)
    7ms
    ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (clinicaltrials.gov)
    P2, N=207, Active, not recruiting, Tracon Pharmaceuticals Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yervoy (ipilimumab) • Enweida (envafolimab)
    8ms
    Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer. (PubMed, Target Oncol)
    Envafolimab yielded promising surgical outcomes and safety in dMMR/MSI-H locally advanced colon cancer, representing a promising treatment modality for this population.
    Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    9ms
    Chidamide plus envafolimab as subsequent treatment in advanced non-small cell lung cancer patients resistant to anti-PD-1 therapy: A multicohort, open-label, phase II trial with biomarker analysis. (PubMed, Cancer Med)
    Combination of chidamide and envafolimab showed efficacy signals in certain NSCLC patients. But further identification of beneficial population is necessary for precision treatment.
    P2 data • Clinical Trial,Phase II • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • HDAC2 (Histone deacetylase 2)
    |
    PD-L1 negative • HDAC2 expression
    |
    Epidaza (chidamide) • Enweida (envafolimab)
    9ms
    ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=126, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | N=200 --> 126 | Trial completion date: Apr 2024 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Aug 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    Enweida (envafolimab)
    9ms
    ASC-ASC22-II-CTP-01: A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients (clinicaltrials.gov)
    P2, N=207, Active, not recruiting, Ascletis Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jun 2023 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Enweida (envafolimab)
    9ms
    CEIL: Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=198, Recruiting, Sun Yat-sen University | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4)
    |
    KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • SMAD4 mutation
    |
    Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
    9ms
    ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC (clinicaltrials.gov)
    P2, N=60, Recruiting, Beijing Hospital
    New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    Erbitux (cetuximab) • irinotecan • Enweida (envafolimab)
    10ms
    A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=86, Terminated, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.
    Trial completion date • Trial termination • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK positive • ROS1 positive • EGFR T790M negative
    |
    docetaxel • irinotecan • leucovorin calcium • Enweida (envafolimab) • suvemcitug (APX003)
    10ms
    Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=16, Recruiting, Nanjing First Hospital, Nanjing Medical University
    New P2 trial • Metastases
    |
    Enweida (envafolimab) • Endostar (recombinant human endostatin)
    10ms
    KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Enweida (envafolimab)
    11ms
    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. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab)
    12ms
    Imaging diagnosis and efficacy monitoring by [Zr]Zr-DFO-KN035 immunoPET in patients with PD-L1-positive solid malignancies. (PubMed, Theranostics)
    Moreover, after antitumor treatment, [Zr]Zr-DFO-KN035 enabled observational imaging for therapeutic efficacy evaluation, which can help predict patient prognosis. [Zr]Zr-DFO-KN035 can be used for the diagnosis and therapy monitoring of PD-L1-positive tumors and provide noninvasive and comprehensive observations for tumor diagnostic imaging, prognosis prediction, and efficacy evaluation.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enweida (envafolimab)
    12ms
    Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma (clinicaltrials.gov)
    P2, N=38, Recruiting, Liangjun Zhu M.M. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 expression
    |
    oxaliplatin • Enweida (envafolimab)
    12ms
    A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=145, Suspended, LaNova Medicines Limited
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101
    1year
    Phase II Study to Determine the Efficacy and Safety of RC48 in Combination with Envafolimab for Neoadjuvant Treatment in Patients with HER2 Over-expressing Muscle-Invasive Bladder Cancer (ChiCTR2300077763 )
    P2, N=32, Not yet recruiting, The First Affiliated Hospital, Zhejiang University School of Medicine
    New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enweida (envafolimab)
    1year
    A Study of HAIC Combined With Lenvatinib and Envolizumab in Potentially Resectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • leucovorin calcium • Enweida (envafolimab)