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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:
    10d
    TQB2450-II-14: Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus. (clinicaltrials.gov)
    P2, N=71, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2024 --> Nov 2025 | Recruiting --> Terminated; Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
    Trial completion date • Trial termination • IO biomarker
    |
    carboplatin • gemcitabine • paclitaxel • docetaxel • Focus V (anlotinib) • doxorubicin hydrochloride • Andewei (benmelstobart)
    21d
    Serum BDNF helps identify favorable subgroups in HCC patients treated with PD-L1 inhibitors and anti-angiogenic TKIs. (PubMed, Ther Adv Med Oncol)
    We aimed to assess the efficacy, safety, and potential biomarkers of anlotinib plus TQB2450 in patients with advanced HCC. Elevated serum BDNF levels might serve as a potential positive prognostic marker and, together with ECOG score, may help complement the CRAFITY score in identifying subgroups that could benefit from ICIs and antiangiogenic therapy. This study was registered on ClinicalTrials.gov (NCT03825705, registered January 31, 2019).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    AFP (Alpha-fetoprotein) • BDNF (Brain Derived Neurotrophic Factor) • CRP (C-reactive protein)
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    30d
    Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC (clinicaltrials.gov)
    P2, N=69, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Focus V (anlotinib) • Andewei (benmelstobart) • Anfangning (garsorasib)
    2ms
    TQB2102-II-03: A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality (clinicaltrials.gov)
    P2, N=270, Recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Trial completion date: Feb 2026 --> Dec 2026 | Trial primary completion date: Oct 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Andewei (benmelstobart) • TQB2102
    3ms
    Combination Therapy with Hypofractionated Radiotherapy, GM-CSF, and Benmelstobart Followed by Bemzutizumab Plus Anlotinib Maintenance in Driver Mutation-Negative Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients Who Failed Prior PD-1/PD-L1 Inhibitor Therapy: A Single-Arm Exploratory Study (ChiCTR2500108817)
    P2, N=69, Not yet recruiting, The Second Affiliated Hospital of Nanjing Medical University; The Second Affiliated Hospital of Nanjing Medical University
    New P2 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK wild-type • ROS1 wild-type • EGFR negative
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    3ms
    The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors (ChiCTR2500108531)
    P2, N=60, Recruiting, The Second Affiliated Hospital of Shandong First Medical University; The Second Affiliated Hospital of Shandong First Medical University
    New P2 trial
    |
    cisplatin • gemcitabine • Focus V (anlotinib) • Andewei (benmelstobart)
    3ms
    TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: An open-label, single-arm, phase II trial. (PubMed, Med)
    This combination therapy shows promising efficacy with a manageable safety profile in rNPC patients. Determination of MIF levels, tumor microenvironment characteristics, TCR profiling, and serial EBV DNA monitoring could identify patients who derive benefits from this therapeutic approach.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MIF (Macrophage Migration Inhibitory Factor)
    |
    Andewei (benmelstobart)
    4ms
    Anlotinib and Benmelstobart in DTC (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fudan University
    New P2 trial
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    4ms
    Case Report: Synergistic multimodal therapy in SMARCA4-deficient undifferentiated tumor: integrating chemotherapy, anti-angiogenesis immunotherapy, and radiotherapy for enhanced outcomes. (PubMed, Front Oncol)
    Sequential PET/CT imaging demonstrated metabolic regression of the primary tumor and metastatic lesions following chemotherapy combined with anti-angiogenic therapy (anlotinib) and PD-L1 inhibition (benmelstobart), followed by consolidative radiotherapy. This case highlights the potential of a mechanistic-driven, multimodal strategy to overcome therapeutic resistance in SMARCA4-deficient undifferentiated tumor. It underscores the need for further exploration of synergistic regimens in this molecular subset.
    Journal
    |
    SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    4ms
    Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=165, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • IO biomarker
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr) • etoposide IV • Xpovio (selinexor) • Andewei (benmelstobart) • Hetronifly (serplulimab)
    5ms
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Sep 2028 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Yidafan (ivonescimab) • AiRuiLi (adebrelimab) • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
    5ms
    Anlotinib plus Benmelstobart (TQB2450) as a first-line treatment for advanced NSCLC who are not suitable for platinum-containing dual chemotherapy: a Phase II, single-arm, multicenter clinical study (ChiCTR2400085457)
    P2, N=42, Recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK fusion • ROS1 fusion
    |
    Focus V (anlotinib) • Andewei (benmelstobart)