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    DRUG:

    benmelstobart (APL-502)

    i
    Other names: APL-502, CBT 502, TQB2450, CBT-502, TQ-B2450
    Company:
    Apollomics, JSR Life Sciences, Sino Biopharm
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    3ms
    Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Peking University
    New P2 trial
    |
    Focus V (anlotinib) • albumin-bound paclitaxel • benmelstobart (APL-502)
    5ms
    A single-arm, open-label, exploratory trial of radiotherapy in combination with TQB2450 and anlotinib hydrochloride in the treatment of relapsed metastatic HER2-negative breast cancer (ChiCTR2300072338)
    P=N/A, N=30, Recruiting, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School; Nanjing Drum Tower Hospital, The Affiliated Hospital of Nan
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    5ms
    Predictive biomarkers of response and survival following immunotherapy with a PD-L1 inhibitor benmelstobart (TQB2450) and antiangiogenic therapy with a VEGFR inhibitor anlotinib for pretreated advanced triple negative breast cancer. (PubMed, Signal Transduct Target Ther)
    Patients with both low MSAF and low bTMB showed a notably better objective response to anlotinib plus TQB2450 (70% vs. 11%, P < 0.001) and a significantly longer median PFS (11.0 vs. 2.9 months, P < 0.001) than patients with other scenarios. Our findings support future studes and validation of MSAF and the combined bTMB-MSAF classification as predictive biomarkers of immune checkpoint inhibitor-based regimens in advanced TNBC patients.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • KMT2C (Lysine Methyltransferase 2C)
    |
    TP53 mutation • TMB-H • PIK3CA mutation • MLL mutation • MLL3 mutation
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    5ms
    Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=148, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • IO biomarker • Metastases
    |
    docetaxel • Focus V (anlotinib) • benmelstobart (APL-502)
    6ms
    A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=135, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • pemetrexed • benmelstobart (APL-502) • AL2846
    8ms
    A randomized double-blind trial of TQB2450 with or without anlotinib in pretreated driver-negative non-small cell lung cancer. (PubMed, Lung Cancer)
    Anlotinib plus TQB2450 demonstrated promising antitumor activities in advanced NSCLC patients without EGFR and ALK alterations and the toxicities were overall manageable. The study findings support the continued development of TQB2450 plus anlotinib for advanced NSCLC patients without driver gene alterations.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    8ms
    Phase Ib study of anlotinib in combination with anti-PD-L1 antibody (TQB2450) in patients with advanced acral melanoma. (PubMed, J Eur Acad Dermatol Venereol)
    TQB2450 combined with anlotinib showed favorable tolerance and promising anti-tumor activity with a prolonged PFS compared with anti-PD1 monotherapy in patients with advanced acral melanoma.
    P1 data • Journal • Combination therapy • Metastases
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    9ms
    Update results of anlotinib combined with TQB2450 (PD-L1 blockade) as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, multicenter, open-label phase II clinical trial (ESMO 2023)
    The common grade ≥3 treatment-related adverse events in 46 patients were hypertension (7%), hyponatremia (4%), low white blood cell count (2%), neutrophil count decreased (2%), platelet count decreased (2%), intestinal obstruction (2%), haemoptysis (2%) and toothache (2%). Conclusions The preliminary results highlighted that anlotinib plus TQB2450 as a first-line therapy for advanced ESCC showed encouraging efficacy and manageable safety profile.
    Clinical • P2 data • Metastases
    |
    FLT1 (Fms-related tyrosine kinase 1)
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    9ms
    A Phase I/II Study of TQ-B2450 plus Anlotinib in EGFR+ Advanced NSCLC Patients Failed to Prior EGFR TKI Therapies:Phase II Results Updates (IASLC-WCLC 2023)
    However, the IMpower150 study subgroup analyses shows Atezolizumab (PD-L1) plus bevacizumab and chemotherapy improved overall survival in EGFR TKI treated NSCLC. The chemo-free combination of TQ-B2450 and anlotinib has shown incredible anti-tumor efficacy and well tolerance in the treatment of EGFR+ advanced NSCLC who failed to prior EGFR TKI therapies. Pts will be continuously monitored to determine longer-term outcomes.
    Clinical • P1/2 data • P2 data • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
    10ms
    A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy (clinicaltrials.gov)
    P1, N=20, Recruiting, Jinming Yu
    New P1 trial
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    10ms
    Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy. (clinicaltrials.gov)
    P3, N=518, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial • Metastases
    |
    docetaxel • benmelstobart (APL-502) • AL2846
    11ms
    A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=58, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    11ms
    A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer. (PubMed, iScience)
    No treatment-related deaths occurred. TQB2450 combined with anlotinib as a chemotherapy-free treatment shows promising efficacy with a manageable safety profile for patients with previously treated advanced TNBC.
    P1 data • Journal • Metastases
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    12ms
    Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma(ESCC) (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, The First Affiliated Hospital of Zhengzhou University | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    12ms
    To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P1/2, N=78, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1/2 trial • Metastases
    |
    benmelstobart (APL-502) • TQB3728
    over1year
    Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=127, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1/2 trial • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    PD-L1 expression • ALK fusion • ALK mutation • ROS1 fusion • ROS1 mutation
    |
    benmelstobart (APL-502) • TQB2618
    over1year
    Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes (clinicaltrials.gov)
    P1/2; N=45; Not yet recruiting; Sponsor:Henan Cancer Hospital
    New P1/2 trial • IO biomarker
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Focus V (anlotinib) • capecitabine • oxaliplatin • benmelstobart (APL-502) • osemitamab (TST001) • fidasimtamab (IBI315)
    2years
    Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. (PubMed, Hepatology)
    Anlotinib combined with TQB2450 showed promising efficacy and was well tolerated in advanced BTCs. KRAS mutation and high TMB might serve as predictors of treatment efficacy.
    P1 data • Journal • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden)
    |
    KRAS mutation • TMB-H
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    2years
    A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC). (clinicaltrials.gov)
    P3, N=390, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK fusion • ROS1 fusion • ALK-ROS1 fusion
    |
    carboplatin • Focus V (anlotinib) • Tevimbra (tislelizumab) • pemetrexed • benmelstobart (APL-502)
    over2years
    A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Paclitaxel as Weekly Treatment of Relapsed Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=405, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    paclitaxel • Focus V (anlotinib) • benmelstobart (APL-502)
    over2years
    A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Paclitaxel as Weekly Treatment of Relapsed Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=405, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P3 trial
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    paclitaxel • Focus V (anlotinib) • benmelstobart (APL-502)
    over2years
    Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Peking University
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    benmelstobart (APL-502) • TQB3616
    over2years
    A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
    P3, N=375, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    Keytruda (pembrolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
    almost3years
    A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
    P3, N=375, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    Keytruda (pembrolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
    3years
    [VIRTUAL] A phase I/II study of TQ-B2450, a PD-L1 mAb, plus anlotinib in EGFR+ advanced NSCLC patients failed to prior EGFR TKI therapies. (ASCO 2021)
    However, the IMpower150 study subgroup analyses showed Atezolizumab (PD-L1) plus bevacizumab and chemotherapy improved overall survival in EGFR TKI treated NSCLC...While 39% pts had T790M mutation who progressed after osimertinib treatment... The chemo-free combination of TQ-B2450, a PD-L1 mAb, plus anlotinib has shown a promising anti-tumor efficacy with a more favorable safety profile for pts with EGFR+ advanced NSCLC who failed to prior EGFR TKI therapies . Pts will be continuously monitored for safety and efficacy readouts (PFS, DOR and OS).
    Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Avastin (bevacizumab) • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
    over3years
    A Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    benmelstobart (APL-502)
    almost4years
    A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
    P3, N=315, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • benmelstobart (APL-502)
    4years
    A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
    P3, N=315, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P3 trial • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • benmelstobart (APL-502)