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    DRUG:

    Sulanda (surufatinib)

    i
    Other names: HMPL-012, HMPL012, HMPL 012
    Company:
    Hutchmed
    Drug class:
    VEGFR inhibitor, FGFR1 inhibitor
    Related drugs:
    22d
    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)
    23d
    A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fujian Cancer Hospital
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
    28d
    Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice（2024 edition） (PubMed, Zhonghua Zhong Liu Za Zhi)
    Common adverse reactions observed during surufatinib treatment include hypertension, proteinuria, bleeding events, and hepatic lab test abnormal and diarrhea. Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice (2024 edition) aims to provide standardized guidance for its rational use and enhance patient compliance to maximize therapeutic benefits.
    Journal
    |
    FGFR1 (Fibroblast growth factor receptor 1) • FLT1 (Fms-related tyrosine kinase 1) • CSF1R (Colony stimulating factor 1 receptor)
    |
    Sulanda (surufatinib)
    1m
    SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=34, Suspended, Zhejiang Cancer Hospital | Recruiting --> Suspended
    Trial suspension • Surgery
    |
    AiRuiKa (camrelizumab) • Sulanda (surufatinib)
    1m
    An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    temozolomide • Sulanda (surufatinib) • Teysuno (gimeracil/oteracil/tegafur)
    3ms
    Pamiparib Combined With Surufatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Bai-Rong Xia | N=20 --> 37
    Enrollment change • Metastases
    |
    HRD (Homologous Recombination Deficiency)
    |
    Partruvix (pamiparib) • Sulanda (surufatinib)
    3ms
    Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer (clinicaltrials.gov)
    P2, N=74, Recruiting, Anhui Provincial Cancer Hospital | N=50 --> 74
    Enrollment change
    |
    Lynparza (olaparib) • carboplatin • sorafenib • paclitaxel • Sulanda (surufatinib)
    4ms
    Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, RenJi Hospital
    New P2 trial • Metastases
    |
    Sulanda (surufatinib) • Hetronifly (serplulimab)
    4ms
    Case report: Metastatic refractory undifferentiated small round-cell sarcoma successfully treated with surufatinib and camrelizumab. (PubMed, Front Oncol)
    In this article, we report a patient with uSRCS who responded to treatment with anti-VEGF inhibitor surufatinib and anti-PD-1 inhibitor camrelizumab after progression on first-line chemotherapy, second-line anlotinib combined with immunotherapy, and third-line chemotherapy...The patient received 4 cycles of the Ifosfamide and epirubicin hydrochloride regimen, and her best objective response was stable disease...Thus, a regimen of gemcitabine plus docetaxel was adopted...As of April 2023, the patient had a progression-free survival time of 26 months. Surufatinib in combination with camrelizumab could be effective in the treatment of advanced uSRCSs.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    AXL (AXL Receptor Tyrosine Kinase) • BCL6 (B-cell CLL/lymphoma 6) • WT1 (WT1 Transcription Factor) • MUC16 (Mucin 16, Cell Surface Associated) • BCOR (BCL6 Corepressor) • EWSR1 (EWS RNA Binding Protein 1) • PIK3CB (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit beta) • TFE3 (Transcription Factor Binding To IGHM Enhancer 3) • CIC (Capicua Transcriptional Repressor)
    |
    gemcitabine • docetaxel • Focus V (anlotinib) • AiRuiKa (camrelizumab) • ifosfamide • epirubicin • Sulanda (surufatinib)
    4ms
    Efficacy and safety of surufatinib combined with chemotherapy in the first-line treatment of unresectable/recurrent and metastatic ampullary tumors: a single arm, prospective, exploratory clinical study (ChiCTR2200061710)
    P4, N=51, Recruiting, Jiangsu Province Hospital; Jiangsu Province Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Sulanda (surufatinib)
    4ms
    A single-arm, single-center Phase II clinical study to evaluate the efficacy and safety of surufatinib combined with toripalimab in the treatment of recurrent ovarian clear cell carcinoma (ChiCTR2400083672)
    P2, N=23, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • ARID1A (AT-rich interaction domain 1A)
    |
    Loqtorzi (toripalimab-tpzi) • Sulanda (surufatinib)
    5ms
    Case report: Remarkable response to later-line surufatinib in an adult patient with liver metastatic of pancreatoblastoma. (PubMed, Front Pharmacol)
    Surufatinib has demonstrated a progression-free survival (PFS) of no less than 14 months, and the patient's survival has endured for a duration of 33 months. This indicates the potential efficacy of surufatinib as a viable therapeutic alternative for adult patients afflicted with PB.
    Journal • Metastases
    |
    TMB (Tumor Mutational Burden) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • KRT19 (Keratin 19)
    |
    Aidixi (disitamab vedotin) • Sulanda (surufatinib)
    5ms
    Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Trial primary completion date: Jun 2024 --> Nov 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
    5ms
    Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    Tyvyt (sintilimab) • oxaliplatin • Sulanda (surufatinib)
    6ms
    Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Anhui Provincial Cancer Hospital
    New P2 trial
    |
    Lynparza (olaparib) • carboplatin • sorafenib • paclitaxel • Sulanda (surufatinib)
    6ms
    Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, National Cancer Center, China
    New P2 trial • Metastases
    |
    Tevimbra (tislelizumab-jsgr) • Sulanda (surufatinib)
    6ms
    A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=482, Recruiting, Hutchmed | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib)
    6ms
    Pamiparib Combined With Surufatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Bai-Rong Xia | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HRD (Homologous Recombination Deficiency)
    |
    Partruvix (pamiparib) • Sulanda (surufatinib)
    7ms
    Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=83, Recruiting, Chinese PLA General Hospital | Trial primary completion date: Feb 2024 --> Jul 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib) • Teysuno (gimeracil/oteracil/tegafur)
    7ms
    Surufatinib combined with photodynamic therapy induces ferroptosis to inhibit cholangiocarcinoma in vitro and in tumor models. (PubMed, Front Pharmacol)
    SUR combined with PDT can significantly enhance the inhibitory effect on CCA, and can be alleviated by two ferroptosis inhibitors (Ferrostatin-1, Deferoxamine). In conclusion, SUR combined with PDT exerted an anti-CCA effect by inducing ferroptosis. Combination therapy provides a new idea for the clinical treatment of CCA.
    Preclinical • Journal
    |
    GPX4 (Glutathione Peroxidase 4) • ACSL4 (Acyl-CoA Synthetase Long Chain Family Member 4)
    |
    Sulanda (surufatinib)
    7ms
    A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Metastases
    |
    Sulanda (surufatinib) • Ariely (adebrelimab)
    7ms
    A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma (clinicaltrials.gov)
    P2, N=160, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Jan 2024
    Enrollment open • Trial initiation date
    |
    cisplatin • Sulanda (surufatinib)
    7ms
    A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=482, Not yet recruiting, Hutchmed
    New P2/3 trial • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib)
    7ms
    Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • Sulanda (surufatinib)
    8ms
    Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P=N/A, N=63, Not yet recruiting, Fudan University
    New trial • Metastases
    |
    gemcitabine • Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
    9ms
    Open-Label Surufatinib in European Patients With NET (clinicaltrials.gov)
    P2, N=78, Active, not recruiting, Hutchmed | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial primary completion date
    |
    Sulanda (surufatinib)
    9ms
    QLYY-iCCA-01: HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Qilu Hospital of Shandong University
    New P2 trial
    |
    Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
    9ms
    Open-label Study of Surufatinib in Japanese Patients (clinicaltrials.gov)
    P1/2, N=36, Active, not recruiting, Hutchison Medipharma Limited | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Sulanda (surufatinib)
    9ms
    A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=130, Completed, Hutchison Medipharma Limited | Active, not recruiting --> Completed
    Trial completion
    |
    Sulanda (surufatinib)
    9ms
    A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=13, Completed, Hutchmed | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • Sulanda (surufatinib)
    10ms
    SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma (clinicaltrials.gov)
    P2, N=34, Recruiting, Zhejiang Cancer Hospital
    New P2 trial • Surgery
    |
    AiRuiKa (camrelizumab) • Sulanda (surufatinib)
    11ms
    Structural basis and selectivity of sulfatinib binding to FGFR and CSF-1R. (PubMed, Commun Chem)
    The insensitivity of sulfatinib to FGFR gatekeeper mutations highlights the indispensable interactions with the hydrophobic pocket for FGFR selectivity, whereas the rotatory flexibility may enable sulfatinib to overcome CSF-1R. This study not only sheds light on the structural basis governing sulfatinib's FGFR/CSF-1R inhibition, but also provides valuable insights into the rational design of dual- or multi-target FGFR inhibitors with selectivity for CSF-1R and sensitivity to gatekeeper mutations.
    Journal
    |
    FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • CSF1R (Colony stimulating factor 1 receptor)
    |
    FGFR mutation
    |
    Sulanda (surufatinib)
    11ms
    Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, Sun Yat-sen University
    Trial completion date • Trial primary completion date • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Lonsurf (trifluridine/tipiracil) • Sulanda (surufatinib)
    11ms
    Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=41, Not yet recruiting, Wuhan Union Hospital, China
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
    11ms
    CCGLC-005: A Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic ICC (clinicaltrials.gov)
    P2, N=18, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2023 --> Jun 2024
    Enrollment open • Trial primary completion date • Metastases
    |
    AiRuiKa (camrelizumab) • Sulanda (surufatinib)
    11ms
    A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma (clinicaltrials.gov)
    P3, N=194, Recruiting, Hutchison Medipharma Limited | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Jul 2023 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    5-fluorouracil • Loqtorzi (toripalimab-tpzi) • irinotecan • leucovorin calcium • Sulanda (surufatinib)
    11ms
    A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Changhai Hospital
    New P2 trial
    |
    Sulanda (surufatinib)
    12ms
    A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy (clinicaltrials.gov)
    P=N/A, N=39, Not yet recruiting, Shanghai Changzheng Hospital
    New trial
    |
    Sulanda (surufatinib) • Hetronifly (serplulimab)
    12ms
    Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=41, Not yet recruiting, Wuhan Union Hospital, China
    New P2 trial • Combination therapy • Metastases
    |
    5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
    1year
    Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Lonsurf (trifluridine/tipiracil) • Sulanda (surufatinib)
    1year
    Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2 | Initiation date: Jul 2023 --> Oct 2023
    Enrollment open • Phase classification • Trial initiation date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • FGFR (Fibroblast Growth Factor Receptor) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CTLA4 expression
    |
    gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
    1year
    A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    Sulanda (surufatinib)