HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

Hong Kong, Shanghai & Florham Park, NJ — Wednesday, December 13, 2023: HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.

The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR). The secondary endpoints include objective response rate (“ORR”), disease control rate (“DCR”), duration of response (“DoR”), time to response (TTR), overall survival (“OS”), safety, and quality of life. A total of 234 patients have been enrolled in the study. The leading principal investigators are Dr Dingwei Ye of Fudan University Shanghai Cancer Center and Dr Zhisong He of Peking University First Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.

The first patient in China received the first dose on October 27, 2022 and HUTCHMED expects to announce topline results from the study around year end 2024. If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration (“NMPA”).

About Kidney Cancer and RCC

It is estimated that approximately 430,000 new patients were diagnosed with kidney cancer worldwide in 2020.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2020.[ii] Approximately 90% of kidney tumors are RCC.

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

About Fruquintinib and Second-line treatment of RCC

Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combination with other anti-cancer therapies including the approved PD-1 inhibitor, sintilimab.

The U.S. Food and Drug Administration (“FDA”) has approved five immune-oncology combination therapies for first-line treatment of advanced RCC, however, no immune-oncology combination therapies have been approved in China, indicating an unmet medical need in these settings.

As presented at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO), a proof of concept study of fruquintinib plus sintilimab demonstrated promising efficacy and tolerable safety profile in this setting. At the data cutoff date of November 30, 2022, all 20 enrolled previously treated patients were efficacy evaluable, and median follow-up duration was 23.3 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and mPFS was 15.9 months. OS was not reached.

[i]  The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf. Accessed September 28, 2022.

[ii] The Global Cancer Observatory, China fact sheet. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed September 30, 2022.