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    DRUG:

    Andewei (benmelstobart)

    i
    Other names: APL-502, CBT 502, TQB2450, CBT-502, TQ-B2450, APL 502, APL502, CBT502, TQB 2450
    Company:
    Apollomics, Sino Biopharm
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    1d
    Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma (clinicaltrials.gov)
    P2, N=33, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2 (Interleukin 2)
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    2d
    Benmelstobart Plus TPF Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 2 Trial (ChiCTR2600119884)
    P2, N=36, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    New P2 trial
    |
    cisplatin • docetaxel • 5-fluorouracil • Andewei (benmelstobart)
    7d
    NimoBenSeq: Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Randomized Controlled Trial (clinicaltrials.gov)
    P2/3, N=386, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Andewei (benmelstobart) • TheraCIM (nimotuzumab)
    7d
    Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    8d
    Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=370, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    cisplatin • bemcentinib (BGB324) • Andewei (benmelstobart) • TheraCIM (nimotuzumab)
    18d
    A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Yongxu Jia | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment closed • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Focus V (anlotinib) • oxaliplatin • Andewei (benmelstobart) • Teysuno (gimeracil/oteracil/tegafur)
    21d
    A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    cisplatin • carboplatin • Focus V (anlotinib) • etoposide IV • Andewei (benmelstobart)
    22d
    Advanced pancreatic ductal adenocarcinoma with liver metastases treated with multimodal therapy: a case report. (PubMed, Front Oncol)
    The patient underwent multimodal comprehensive treatment, including iodine-125 seed implantation at the pancreatic primary site, eight cycles of hepatic arterial infusion chemotherapy, PD-L1 inhibitor (Benmelstobart), and oral S-1 maintenance therapy. After treatment, the patient's liver metastases significantly decreased in size (partial response according to RECIST 1.1), CA19-9 levels dropped from 4141.57 U/mL to 58.64 U/mL, overall survival exceeded 15 months, and quality of life remained good (ECOG score 1). The MDT strategy, particularly the combination of local interventional therapy with systemic treatment and immunotherapy, can effectively control both the primary and metastatic lesions of advanced PDAC, significantly prolonging patient survival and providing valuable treatment references for similar cases.
    Journal
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Andewei (benmelstobart)
    1m
    BACON: Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    Focus V (anlotinib) • cyclophosphamide • Andewei (benmelstobart)
    1m
    Benmelstobart plus anlotinib versus pembrolizumab as first-line treatment for PD-L1-positive, advanced non-small-cell lung cancer (CAMPASS): a blinded, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival.
    P3 data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Focus V (anlotinib) • Andewei (benmelstobart)
    2ms
    A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=578, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University
    New P3 trial
    |
    TP53 (Tumor protein P53) • FAT1 (FAT atypical cadherin 1) • NOTCH3 (Notch Receptor 3)
    |
    TP53 mutation
    |
    cisplatin • paclitaxel • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Andewei (benmelstobart)
    2ms
    Anlotinib and Benmelstobart in DTC (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fudan University | Initiation date: Oct 2025 --> Apr 2026
    Trial initiation date
    |
    Focus V (anlotinib) • Andewei (benmelstobart)