HONG KONG and FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA^® in China) in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma (“NEC”) who have progression of disease or intolerable toxicity after previous first-line chemotherapy. The first patient was dosed on September 18, 2021 in China. Toripalimab is marketed as TUOYI^® in China by Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”).

Professor Shen Lin, the lead principal investigator of the study and Vice President of Peking University Hospital and Cancer Institute, said: “There is a large unmet clinical need for patients with NEC, many of whom have a bleak prognosis. Following the encouraging preliminary data from the Phase II trial, we are excited to move into the next stage of development in combining the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody toripalimab. We look forward to further testing the synergistic anti-tumor effects of this combination that could benefit NEC patients who have limited treatment options.”

At the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, encouraging preliminary data from the Phase II trial were disclosed for the surufatinib and toripalimab combination¹. For the 20 patients in the NEC cohort as of December 31, 2020, who received an average of 5 cycles of treatments and are efficacy evaluable, objective response rate (“ORR”) was 20% and disease control rate (“DCR”) was 70%. Median progression-free survival (“PFS”) was 3.9 months (95% CI: 1.3 – not reached). Grade 3 or higher treatment-related adverse events occurred in 33% of patients. Treatment related adverse events (“TRAEs”) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively. There were neither serious adverse events (“AEs”) nor AEs inducing treatment discontinuations or deaths. Updated data will be presented at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting in late September.

The SURTORI-01 Phase III study is a randomized, controlled, open-label, multi-center study where approximately 200 patients are expected to be enrolled. For the study group, all patients will receive study treatment in 21-day cycle and the treatment will continue until there is a progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first. The primary outcome measure is OS. The secondary outcome measures include PFS, ORR, duration of response (DoR), and DCR. Additional details may be found at clinicaltrials.gov, using identifier NCT05015621.

HUTCHMED is the sponsor of SURTORI-01 and responsible for all clinical and regulatory execution of the Phase III study. HUTCHMED and Junshi Biosciences are jointly funding the study.

Surufatinib is marketed in China under the brand name SULANDA^® for treating advanced neuroendocrine tumors (“NETs”).

About NEC

Neuroendocrine neoplasms (“NEN”) occur almost everywhere in the body but are most common in the gastrointestinal tract, pancreas, and lungs. NEC is one of the two common phenotypes of NEN. NECs are poorly differentiated, highly proliferating NENs, while NETs are well-differentiated, low-proliferating NENs. NECs are aggressive, fast-growing neoplasms that usually fail to express hormones or produce hormonal syndromes, and are not associated with hereditary tumor diseases.²