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    DRUG:

    Fumena (vorolanib)

    i
    Other names: X-82, CM-082, challenge meditech 082
    Company:
    Betta Pharma, Tyrogenex
    Drug class:
    VEGFR inhibitor, PDGFR inhibitor, Tyrosine kinase inhibitor, CSF-1R inhibitor
    Related drugs:
    12d
    Vorolanib in the Second-line Treatment of Patients with Unresectable or Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=39, Recruiting, Jinling Hospital, China
    New trial • Metastases
    |
    Fumena (vorolanib)
    1m
    CA209-982: Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov)
    P1/2, N=88, Completed, Vanderbilt-Ingram Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Apr 2024
    Trial completion • Trial completion date • Combination therapy • Tumor mutational burden
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    2ms
    A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New trial • Metastases
    |
    Kaitanni (cadonilimab) • Fumena (vorolanib)
    2ms
    VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov)
    P2, N=25, Recruiting, EyePoint Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Eylea (aflibercept intravitreal) • Fumena (vorolanib)
    3ms
    Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients (clinicaltrials.gov)
    P1/2, N=37, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1/2 trial
    |
    Kaitanni (cadonilimab) • Fumena (vorolanib)
    8ms
    Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Vanderbilt-Ingram Cancer Center | Trial primary completion date: Jul 2024 --> Feb 2024
    Trial primary completion date • Combination therapy • Tumor mutational burden
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    9ms
    A Phase 1/2 Study to Evaluate the Safety and Activity of Nivolumab in Combination With Vorolanib, a Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor, in Patients With Refractory Thoracic Tumors. (PubMed, JTO Clin Res Rep)
    Vorolanib plus nivolumab had a manageable safety profile and may have clinical benefits in various thoracic malignancies. The disease control rate in thymic malignancies warrants further assessment.
    Clinical • P1/2 data • Journal • Combination therapy
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • PD-1 (Programmed cell death 1)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    over1year
    Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Vanderbilt-Ingram Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    over1year
    PRIMARY EXTRAGONADAL GERM CELL TUMOR OF THE ANTERIOR MEDIASTINUM: A CASE REPORT (CHEST 2023)
    Computed tomography (CT) of the chest with contrast revealed a large, well-defined soft tissue attenuating anterior mediastinal mass measuring 89 x 89 x 82 milimeters with few prominent prevascular and paraaortic lymph nodes, and minimal pericardial and pleural effusion...The patient was referred to an oncologist wherein he was started on a cisplatin-based chemotherapy... When aggressive radiation and chemotherapy treatments are utilized, seminomas are curable. Hence, it is prudent to do systematic investigation, perform biopsy of the lesion for the definitive diagnosis, appropriate management and higher survival chances.
    Clinical
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • AFP (Alpha-fetoprotein) • SALL4 (Spalt Like Transcription Factor 4)
    |
    cisplatin • Fumena (vorolanib)
    2years
    Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Vanderbilt-Ingram Cancer Center | Suspended --> Active, not recruiting | N=177 --> 88
    Enrollment closed • Enrollment change • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    over2years
    Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov)
    P1/2, N=177, Suspended, Vanderbilt-Ingram Cancer Center | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Opdivo (nivolumab) • Fumena (vorolanib)
    over3years
    Vorolanib (X-82), an oral anti-VEGFR/PDGFR/CSF1R tyrosine kinase inhibitor, with everolimus in solid tumors: results of a phase I study. (PubMed, Invest New Drugs)
    Further studies are warranted. Trial Registration Number: NCT01784861.
    P1 data • Journal
    |
    CSF1R (Colony stimulating factor 1 receptor)
    |
    everolimus • Fumena (vorolanib)
    over4years
    CM082, a novel angiogenesis inhibitor, enhances the antitumor activity of gefitinib on epidermal growth factor receptor mutant non-small cell lung cancer in vitro and in vivo. (PubMed, Thorac Cancer)
    Significant findings of the study CM082, a novel angiogenesis inhibitor, enhances the antitumor activity of gefitinib on EGFR mutant NSCLC by inhibiting proliferation and angiogenesis and promoting apoptosis of tumor cells. What this study adds These findings justify evaluation of the efficacy of CM082 combined with gefitinib in patients with EGFR mutant advanced NSCLC in clinical trials.
    Preclinical • Journal
    |
    EGFR (Epidermal growth factor receptor) • STAT3 (Signal Transducer And Activator Of Transcription 3) • CD31 (Platelet and endothelial cell adhesion molecule 1)
    |
    EGFR L858R • CD31 expression
    |
    gefitinib • Fumena (vorolanib)
    over4years
    Phase 1 trial of vorolanib (CM082) in combination with everolimus in patients with advanced clear-cell renal cell carcinoma. (PubMed, EBioMedicine)
    Combination therapy of vorolanib 200 mg plus everolimus 5 mg once daily is potentially effective with potential activity. Further evaluation of the combination in advanced RCC patients is ongoing (NCT03095040).
    Clinical • P1 data • Journal • Combination therapy
    |
    mTOR (Mechanistic target of rapamycin kinase)
    |
    everolimus • Fumena (vorolanib)
    over4years
    [VIRTUAL] A phase II study of vorolanib (CM082) in combination with toripalimab (JS001) in patients with advanced mucosal melanoma. (ASCO 2020)
    PFS benefit was observed in both 150mg and 200mg subgroups. This study demonstrated potentially improved efficacy with predictable toxicities of CM082 in combination with JS001 therapy, which may be an effective treatment option for pts with advanced mucosal melanoma. Research Funding: Betta Pharmaceuticals Co.,Ltd
    Clinical • P2 data • Combination therapy
    |
    PD-1 (Programmed cell death 1)
    |
    Loqtorzi (toripalimab-tpzi) • Fumena (vorolanib)