Hong Kong-based biopharmaceutical company Hutchmed has begun a Phase II/III clinical trial of surufatinib in combination with other drugs as a first-line therapy for metastatic pancreatic ductal adenocarcinoma (PDAC) in China.
The treatment regimen includes surufatinib alongside camrelizumab from Jiangsu Hengrui Pharmaceuticals, as well as nab-paclitaxel and gemcitabine.
The first patient in the study received their first dose on 8 May.
The randomised, open-label trial is designed to assess the efficacy and safety of the surufatinib combination regimen against that of the standard nab-paclitaxel plus gemcitabine treatment.
Adult patients with metastatic pancreatic cancer who have not previously received systemic anti-tumour treatment are eligible for the trial.
Following an initial safety run-in phase, the trial is expected to enrol 500 more patients.
Its primary endpoint is overall survival, with secondary endpoints including objective response rate, progression-free survival, disease control rate, safety, quality of life, duration of response and time to response.
Surufatinib is an oral angio-immuno kinase inhibitor approved for treating non-pancreatic and pancreatic neuroendocrine tumours.
The drug is known commercially as Sulanda in China and was first added to the country's National Reimbursement Drug List in January 2022.
HUTCHMED CEO and chief scientific officer Dr Weiguo Su said: “Emerging data, including those from an investigator-initiated study presented at the ASCO Gastrointestinal Cancers Symposium, demonstrated that combinations of surufatinib, camrelizumab and chemotherapy have promising efficacy in comparison with existing chemotherapy-based treatments in metastatic PDAC.
“We hope that this partnership will enable us to bring new, potentially life-changing treatment options to patients.”
In December 2023, Hutchmed finished enrolling subjects in a Phase II/III clinical trial of fruquintinib plus sintilimab as a second-line treatment option for patients with locally advanced or metastatic renal cell carcinoma in China.
The company said it planned to report topline data from the trial by the end of this year.
