Sulanda (surufatinib) / Hutchmed - LARVOL DELTA

Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: Results from phase II part of a randomized, open-label, active-controlled, phase II/III study (ESMO Asia 2025) - P2/3 | "S+C+AG regimen significantly improved median PFS versus AG alone, with consistent benefits across key efficacy endpoints. The safety profile is manageable. The tetrad regimen may emerge as a new frontline option for the targeted population."

Clinical • Combination therapy • Metastases • P2/3 data • Oncology • Pancreatic Cancer • Solid Tumor • FGFR

Matching-adjusted indirect comparison of surufatinib versus high-dose octreotide LAR in advanced extrapancreatic neuroendocrine tumors (ESMO Asia 2025) - P3 | "This unanchored MAIC suggests surufatinib may improve survival outcomes compared to HD-OCT in advanced epNETs, with a clinically meaningful RMST advantage. The trend aligns with SANET-ep's primary results, supporting surufatinib as a viable therapeutic option."

Metastases • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Real-world efficacy and safety of surufatinib in advanced neuroendocrine neoplasm. (ASCO-GI 2026) - P4 | "Clinical Trial Registration Number: ChiCTR2100049999 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Gastrointestinal Cancer • Solid Tumor

ZSPAC-17: Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms (clinicaltrials.gov) - P4 | N=350 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P4 trial • Real-world evidence • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

HUTCHMED (China) Limited…announces that following the contract renewal with the China National Healthcare Security Administration (’NHSA’), the updated National Reimbursement Drug List (’NRDL’) effective on January 1, 2026 will continue to include…SULANDA (GlobeNewswire) - "SULANDA (surufatinib) is renewed for the treatment of patients with unresectable; locally advanced or metastatic; progressive non-functional, well-differentiated (G1 or G2) pancreatic and non-pancreatic neuroendocrine tumors."

Reimbursement • Pancreatic Neuroendocrine Tumor

Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma. (PubMed, Cell Rep Med) - P2 | "Exploratory analysis indicates that responders show significantly higher tumor PD-L1 expression than non-responders do, with median tumor proportion scores of 8% and 2%, respectively. The study is registered at ClinicalTrials.gov (NCT05236699)."

IO biomarker • Journal • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • FGFR2 • PD-L1

Efficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label study. [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • Combination therapy • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Surufatinib in Combination with Serplulimab, Etoposide, and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Preliminary Results from a Single-Arm, Phase Ia/Ib Study (ESMO-IO 2025) - P1/2 | "Subgroup analysis revealed a longer median PFS in pts without liver metastases (vs. pts with liver metastasis, 7.6 vs. 4.6 months, p=0.0821), and in pts with ≤ 2 metastatic organs (vs. pts with >2, 6.5 vs. 4.9 months, p=0.4787). Grade ≥ 3 treatment-emergent adverse events included neutropenia (47.62%), leukopenia (23.81%), and thrombocytopenia (14.29%).Conclusions The combination of surufatinib, serplulimab, and EC demonstrated promising antitumor activity and survival benefits, with manageable toxicity, as a first-line treatment for ES-SCLC, particularly in patient without liver metastases.Clinical trial identification NCT05882630.Legal entity responsible for the study Fujian Cancer Hospital and Beijing Chest Hospital."

Clinical • Combination therapy • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CSF1R • FGFR1 • FLT1

Efficacy and safety of tislelizumab plus surufatinib in later-line treatment of metastatic colorectal cancer: A single-arm, phase ii trial with a negative result (ESMO-IO 2025) - P4 | "This negative trial highlights the therapeutic challenge in refractory mCRC and indicates that combining immunotherapy with anti-angiogenic therapy is insufficient for most patients. Future strategies should prioritize biomarker-driven approaches and novel mechanisms to overcome immunotherapy resistance in MSS CRC.Clinical trial identification ChiCTR2200059848.Legal entity responsible for the study Huijun Xu, Ying Yan, Jiayu Niu, Lulu Cao,Gang Wang, Wenju Chen, Mengge Li, Huiqin Luo, Lihong Ke, Shusheng Wu, Yifu He."

Clinical • IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • CSF1R • FGFR1 • FLT1

Real-world application of surufatinib in the treatment of neuroendocrine tumors: a multi-center retrospective study in China. (PubMed, Eur J Med Res) - "A higher proportion of patients in the surufatinib treatment cohort experienced proteinuria (9 [3.2%] vs. 10 [10.8%], P = 0.010) and increased blood bilirubin levels (25 [8.9%] vs. 16 [17.2%], P = 0.027), however, no significant differences were observed in the severity of adverse reactions. Surufatinib showed clinically meaningful efficacy in patients with NETs and exhibited a generally manageable safety profile."

Journal • Real-world evidence • Retrospective data • Neuroendocrine Tumor • Oncology • Renal Disease • Solid Tumor

Efficacy and Safety of Non-Surgical Treatments for Pancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis. (PubMed, Pharmaceuticals (Basel)) - "Targeted therapies showed modest objective response rates (ORRs) but high disease control rates (DCRs): everolimus (ORR 7%, 95% CI: 3-10%; DCR 81%, 95% CI: 75-87%), sunitinib (ORR 12%, 95% CI: 5-19%; DCR 79%, 95% CI: 70-88%), surufatinib (ORR 19%, 95% CI: 12-27%; DCR 81%, 95% CI: 73-89%). Cytotoxic chemotherapy demonstrated higher ORRs: dacarbazine-based (32%, 95% CI: 21-43%), streptozocin-based (40%, 95% CI: 25-54%), temozolomide-based (42%, 95% CI: 29-55%). PRRT showed varying efficacy: 177Lu-DOTATATE (ORR 36%, 95% CI: 27-44%; DCR 84%, 95% CI: 76-92%), 90Y-DOTATOC (ORR 27%, 95% CI: 18-36%; DCR 73%, 95% CI: 63-83%)...Immunotherapy with pembrolizumab showed limited efficacy (ORR 7%, 95% CI: 0-14%)...PRRT also shows robust antitumor activity and disease control, while SSAs and targeted therapies are effective treatment options for disease stabilization. Immunotherapy demonstrated limited antitumor activity, and further research is needed to establish its role in pNET..."

Clinical • Journal • Retrospective data • Review • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

PTPN9 dephosphorylates IGF1RY1165/1166 and alleviates IGF1R-mediated resistance to tyrosine kinase inhibitor in cholangiocarcinoma (J Exp Clin Cancer Res) - "Establishment of a surufatinib-resistant CCA cell line further confirmed decreased PTPN9 expression and elevated IGF1R signaling. In vivo blockade of IGF1R signaling significantly enhanced surufatinib sensitivity."

Preclinical • Cholangiocarcinoma

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress… (GlobeNewswire) - "Results from...the phase II part of the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma, will be presented at the ESMO Asia Congress 2025. Results from the phase II part of the phase II/III study of surufatinib in combination with camrelizumab and chemotherapy as a first-line treatment for metastatic pancreatic cancer will also be reported."

P2 data • Pancreatic Cancer • Renal Cell Carcinoma

PTPN9 dephosphorylates IGF1RY1165/1166 and alleviates IGF1R-mediated resistance to tyrosine kinase inhibitor in cholangiocarcinoma. (PubMed, J Exp Clin Cancer Res) - "Increasing evidence suggests that a subset of CCA patients can benefit from multiple tyrosine kinase inhibitors (mTKIs) such as surufatinib...Furthermore, cancer-associated fibroblasts (CAFs) were identified as the major source of IGF1 in CCA microenvironment, essential for IGF1R-driven tumor progression.In summary, the PTPN9-IGF1R axis plays a pivotal role in modulating mTKI sensitivity and tumor progression in CCA. This axis serves as a promising biomarker for identifying potential mTKI beneficiaries and represents a potential therapeutic target to enhance mTKI efficacy and overcome resistance."

Journal • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • CAFs • IGF1 • PTPN9

Synergistic Anti-Tumor Effects of Sulfatinib and Kaempferol on Pancreatic Neuroendocrine Tumors via CALCA-mediated PI3K/AKT/mTOR Pathway. (PubMed, Int J Biol Sci) - "In summary, our findings provide novel insights into combination therapy for pNETs while elucidating the mechanistic role of CALCA in the modulation of angiogenesis. This research establishes a foundation for the development of vascular-targeted combination therapeutic strategies for the treatment of pNETs."

Journal • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

A real-world retrospective analysis to evaluate the efficacy and safety of surufatinib in the treatment of advanced neuroendocrine neoplasms in China. (PubMed, Endocr Connect) - "Patients with TRAEs ≥1 (hazard ratio [HR] 0.349, P = 0.048) had longer PFS. This study supported the activity of surufatinib in advanced NENs; subgroup findings, including those for NEC, were exploratory and required confirmation."

Journal • Real-world evidence • Retrospective data • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

A case report: enhanced somatostatin receptor expression in metastatic pancreatic neuroendocrine tumor following everolimus therapy. (PubMed, Front Cell Dev Biol) - "From August 2019 to October 2020, he received long-acting octreotide and transarterial chemoembolization (TACE), achieving stable disease...In September 2022, oral surufatinib was initiated but paused in September 2023 due to adverse effects...This case demonstrates that everolimus can induce SSTR re-expression in advanced, SSTR-negative pNETs, offering new therapeutic possibilities. The "induction plus re-evaluation" approach could guide personalized treatment strategies in late-stage pNETs, although further studies are needed to validate this approach."

Journal • Gastrointestinal Disorder • Hepatology • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR • SSTR2

Efficacy and safety of surufatinib in patients with advanced soft tissue sarcoma after failure of anthracycline chemotherapy and prior effective antiangiogenic therapy: A single-arm, prospective, exploratory phase II study (ESMO 2025) - P2 | "Background While pazopanib/anlotinib/regorafenib are guideline-endorsed second-line therapies for advanced soft tissue sarcoma (STS), the efficacy of tyrosine kinase inhibitor (TKI) rechallenge after disease progression remains underexplored. The most common TEAE (treatment emergent adverse event) were hypertension, proteinuria and fatigue. Conclusions Surufatinib demonstrated promising efficacy and favorable tolerability in patients with unresectable metastatic soft tissue sarcoma (STS) who had failed anthracycline chemotherapy and and prior antiangiogenic therapy despite initial clinical benefit."

Clinical • Metastases • P2 data • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Surufatinib plus paclitaxel as second-line therapy for advanced gastric cancer: a single-arm, phase 2 clinical trial. (PubMed, Cell Oncol (Dordr)) - P=N/A | "Surufatinib plus paclitaxel showed promising efficacy and manageable safety as second-line treatment for advanced gastric cancer, especially in patients who had failed prior immunotherapy."

Journal • P2 data • Cardiovascular • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Surufatinib for Pancreatic Cancer (GlobeNewswire) - "The Phase II/III study of surufatinib combined with Hengrui's camrelizumab (a PD-1 antibody), nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) remains on track. Results from the Phase II portion will be presented at an upcoming scientific conference."

P2 data • Trial status • Pancreatic Ductal Adenocarcinoma

​A Clinical Study of Sintilimab Combined with Surufatinib in the Treatment of Recurrent Small Cell Lung Cancer​ (ChiCTR) - P=N/A | N=19 | Recruiting | Sponsor: ​The 980th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army​; The 980th Hospital of the Joint Logistics Suppo

New trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

First-line treatment with chemotherapy, surufatinib (an angio-immuno kinase inhibitor), and camrelizumab (an anti-PD-1 antibody) for locally advanced or metastatic pancreatic ductal adenocarcinoma: a phase Ib/II randomized study. (PubMed, Signal Transduct Target Ther) - P1/2 | "Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis and limited first-line treatments. In the NASCA group, enrichment of CD8+ and CD8+PD-1+ cells, a high baseline M1/M2 macrophage ratio, and a reduction in CA19-9 levels at weeks 6 and 12 were associated with improved PFS compared to patients without these features. The NASCA regimen showed promising efficacy with tolerable safety relative to nab-paclitaxel and gemcitabine for locally advanced or metastatic PDAC."

Clinical • Journal • P1/2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9 • CD8 • PD-1

Enhancing cisplatin therapy for small cell lung cancer via a dual strategy of combining surufatinib and CD47 blockade. (PubMed, J Control Release) - "The combination of CS/RGD-Lipo with αCD47 significantly promoted ferroptosis in SCLC, improved anti-angiogenesis, induced the conversion of M2 macrophages to M1 macrophages, and enhanced the M1 macrophages-mediated antitumor immune response, resulting in a marked inhibition of tumor growth in SCLC mouse models. Taken together, this work demonstrates a feasible therapeutic approach to inhibit SCLC by combining cisplatin, surufatinib, and αCD47 to leverage tumor ferroptosis, angiogenesis inhibition and tumor-associated macrophage polarization."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy/safety and preliminary scRNA-seq results of surufatinib plus gemcitabine and nab-paclitaxel as neoadjuvant therapy in resectable and borderline resectable pancreatic cancer (ESMO 2025) - P2 | "Conclusions AGS regimen demonstrates significant clinical benefits as neoadjuvant treatment for PC, inducing tumor regression, reducing surgical complexity, and achieving high R0 rate with manageable toxicity. The tumor microenvironment of responders revealed the full activated landscape of the tumor microenvironment by surufatinib."

Clinical • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • FGFR1 • GZMB • GZMH