HUTCHMED Starts Phase II/III Trial of Surufatinib and Camrelizumab for Untreated Pancreatic Cancer with Hengrui

HUTCHMED (China) Limited has announced the commencement of a Phase II/III clinical trial aimed at evaluating the effectiveness of a drug combination for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) in China. This study will investigate the use of HUTCHMED’s surufatinib, Hengrui Pharma’s PD-1 antibody camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for patients with this aggressive form of cancer. The first patient received their initial dose on May 8, 2024.

PDAC is the most common type of pancreatic cancer, accounting for over 90% of pancreatic cancer cases globally. In 2022, approximately 511,000 people worldwide were diagnosed with pancreatic cancer, resulting in around 467,000 deaths. The disease has a particularly low five-year survival rate, averaging less than 10%. In China alone, pancreatic cancer resulted in an estimated 119,000 diagnoses and approximately 106,000 deaths in 2022. Current treatment options, such as chemotherapy, surgery, and radiation, have shown limited effectiveness, with less than 20% of metastatic pancreatic cancer patients surviving beyond one year.

The trial being conducted by HUTCHMED is a multicenter, randomized, open-label, active-controlled Phase II/III study. It aims to compare the efficacy and safety of the drug combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine against the standard treatment of nab-paclitaxel plus gemcitabine in adults with metastatic pancreatic cancer who have not received prior systemic anti-tumor therapy. Following an initial safety run-in phase, the study plans to enroll up to 500 additional patients. The primary endpoint of the study is overall survival (OS), with secondary endpoints including objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), safety, quality of life, duration of response, and time to response.

Dr. Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, highlighted the promising efficacy of the drug combination based on emerging data from an investigator-initiated study presented at the ASCO Gastrointestinal Cancers Symposium. He expressed hope that this collaboration would lead to new, potentially transformative treatment options for patients with metastatic PDAC.

Surufatinib is an oral angio-immuno kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFRs), fibroblast growth factor receptor (FGFR), and colony-stimulating factor-1 receptor (CSF-1R). This dual mechanism inhibits angiogenesis and regulates tumor-associated macrophages, thus enhancing the immune response against tumor cells. Surufatinib is marketed in China under the brand name SULANDA® and was added to the China National Reimbursement Drug List (NRDL) in January 2022 for the treatment of neuroendocrine tumors (NETs).

Camrelizumab, marketed as AiRuiKa®, is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. It is approved in China for nine indications, including various cancers such as hepatocellular carcinoma (HCC) and non-small cell lung cancer. The U.S. FDA has granted Orphan Drug Designation to camrelizumab for advanced HCC and has accepted a New Drug Application for it as part of a first-line therapy for unresectable HCC, with a decision expected in May 2024.

Hengrui Pharma, a leading pharmaceutical company in China, focuses on the research, development, manufacturing, and commercialization of innovative healthcare products. The company is recognized globally, ranking 24th among the top 1,000 pharmaceutical companies in 2021. HUTCHMED, a biopharmaceutical company committed to developing targeted therapies and immunotherapies for cancer and immunological diseases, employs approximately 5,000 personnel across its companies, with around 1,800 focused on oncology and immunology. HUTCHMED has successfully brought its first three medicines to market in China, with one also available in the U.S.