The Phase II/III clinical trial is designed to analyse fruquintinib plus sintilimab in locally advanced or metastatic renal cell carcinoma patients. Credit: Nemes Laszlo / Shutterstock.com.

Hutchmed has concluded subject enrolment in the 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 (RCC) in China.

The open-label, randomised, active-controlled trial will analyse the safety and efficacy of fruquintinib plus sintilimab compared to axitinib or everolimus in 234 patients. 

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Progression-free survival (PFS) is the trial’s primary endpoint while secondary endpoints comprise objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and time to response (TTR) among others. 

Dr Dingwei Ye from Fudan University Shanghai Cancer Center and Dr Zhisong He from Peking University First Hospital are acting as the lead principal investigators of the study.

Hutchmed dosed the first trial subject in the country on 27 October last year and plans to report topline data by the end of next year. 

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On obtaining favourable data, the company will submit a new drug application to China’s National Medical Products Administration (NMPA).

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Fruquintinib is a vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 inhibitor with a manageable safety profile. It is also being evaluated along with other anti-cancer treatments, including an approved medicine, sintilimab.

According to data from a proof of concept study, fruquintinib plus sintilimab offered an encouraging efficacy and safety profile in an RCC setting. 

The treatment also offered ORR and DCR of 60% and 85%, respectively. Furthermore, 13.9 months and 15.9 months were the median DoR and median PFS in the trial.

In September this year, the company concluded subject enrolment in a bridging study of tazemetostat for the treatment of relapsed/refractory follicular lymphoma (R/R FL) in China.

Dr Junning Cao of Shanghai Fudan University Cancer Centre is acting as the lead principal investigator for the open-label, multicentre study.

This study is designed to analyse the pharmacokinetics, safety, and efficacy of tazemetostat in R/R FL patients.