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DRUG:

Sulanda (surufatinib)

i
Other names: HMPL-012, HMPL012, HMPL 012
Company:
Hutchmed
Drug class:
VEGFR inhibitor, FGFR1 inhibitor
3d
Development of a UPLC-MS/MS method for the determination of sulfatinib and its no interaction with myricetin in rats. (PubMed, Front Pharmacol)
Acetonitrile was used to precipitate the plasma protein, and lenvatinib was employed as the internal standard (IS). This may be due to insufficient doses of myricetin, or failure of myricetin to act in a timely manner in vivo. The findings contributed to a better understanding of the metabolism and drug-drug interaction of sulfatinib, but the presence or absence of interactions needs to be confirmed by further studies.
Preclinical • Journal
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FGFR (Fibroblast Growth Factor Receptor) • CSF1R (Colony stimulating factor 1 receptor)
|
Lenvima (lenvatinib) • Sulanda (surufatinib)
16d
New P2 trial
|
cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • Sulanda (surufatinib)
1m
QLYY-iCCA-01: HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=28, Active, not recruiting, Qilu Hospital of Shandong University | Recruiting --> Active, not recruiting | Trial primary completion date: May 2024 --> Dec 2024
Enrollment closed • Trial primary completion date
|
Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
2ms
New P2 trial
|
Sulanda (surufatinib) • Enweida (envafolimab)
2ms
New P2 trial • Metastases
|
Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
2ms
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
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FGFR1 (Fibroblast growth factor receptor 1) • FLT1 (Fms-related tyrosine kinase 1) • CSF1R (Colony stimulating factor 1 receptor)
|
Sulanda (surufatinib)
2ms
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)
3ms
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)
4ms
Enrollment change • Metastases
|
HRD (Homologous Recombination Deficiency)
|
Partruvix (pamiparib) • Sulanda (surufatinib)
4ms
Enrollment change
|
Lynparza (olaparib) • carboplatin • sorafenib • paclitaxel • Sulanda (surufatinib)
5ms
New P2 trial • Metastases
|
Hetronifly (serplulimab) • Sulanda (surufatinib)
5ms
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
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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)
5ms
Enrollment open
|
Sulanda (surufatinib)
5ms
New P2 trial
|
PD-L1 (Programmed death ligand 1) • ARID1A (AT-rich interaction domain 1A)
|
Loqtorzi (toripalimab-tpzi) • Sulanda (surufatinib)
6ms
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)
6ms
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)
7ms
New P2 trial • Metastases
|
Tyvyt (sintilimab) • oxaliplatin • Sulanda (surufatinib)
7ms
New P2 trial
|
Lynparza (olaparib) • carboplatin • sorafenib • paclitaxel • Sulanda (surufatinib)
7ms
New P2 trial • Metastases
|
Tevimbra (tislelizumab-jsgr) • Sulanda (surufatinib)
7ms
Enrollment open • Metastases
|
gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib)
8ms
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)
8ms
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)
8ms
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)
8ms
New P2 trial • Metastases
|
Sulanda (surufatinib) • Ariely (adebrelimab)
8ms
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)
8ms
New P2/3 trial • Metastases
|
gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib)
9ms
New P2 trial • Metastases
|
gemcitabine • albumin-bound paclitaxel • Sulanda (surufatinib)
9ms
New trial • Metastases
|
gemcitabine • Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
10ms
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)
10ms
New P2 trial
|
Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
11ms
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)
11ms
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)
11ms
Trial completion
|
gemcitabine • Sulanda (surufatinib)
12ms
New P2 trial • Surgery
|
AiRuiKa (camrelizumab) • Sulanda (surufatinib)
12ms
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)
12ms
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)
12ms
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
|
5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
1year
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)
1year
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)
1year
New P2 trial
|
Sulanda (surufatinib)
1year
New trial
|
Hetronifly (serplulimab) • Sulanda (surufatinib)
1year
New P2 trial • Combination therapy • Metastases
|
5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)