The combination has been evaluated as a second-line therapy in patients with renal cell carcinoma in China. Image credit: crystal light / Shutterstock.
Chinese-based Innovent Biologics and HUTCHMED are eyeing approval for their cancer combination after a joint Phase II/III kidney cancer trial met its primary and key secondary endpoints.
The FRUSICA-2 study (NCT05522231) evaluated a combination of Innovent’s Tyvyt (sintilimab) and HUTCHMED’s Elunate (fruquintinib) as a second-line treatment in patients with locally advanced or metastatic renal cell carcinoma in patients in China.
The trial met its primary endpoint of progression-free survival (PFS) per RECIST 1.1. The combination also demonstrated efficacy in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). The companies have not released the specific data on these endpoints.
The companies will be sharing the data with regulatory authorities and progressing toward a new drug application (NDA) filing this year.
Full results will be submitted for presentation at an upcoming scientific conference.
The FRUSICA-2 study is a randomised, open-label, active-controlled study to evaluate the efficacy and safety of Tyvyt and Elunate versus Pfizer’s Inlyta (axitinib) or Novartis’ Afinitor (everolimus).
Innovent senior vice president Dr Hui Zhou said: “We are encouraged by the positive results in the FRUSICA-2 clinical trial. These outcomes not only underscore the great potential of the combination therapy of Tyvyt and Elunate but also bring new hope to previously treated patients with advanced renal cell carcinoma. We look forward to working closely with HUTCHMED to jointly advance the registrational communication of this innovative combo therapy and make it available to patients as soon as possible.”
The same combination was evaluated in the FRUSICA-1 study (NCT03903705) in patients with advanced endometrial cancer with mismatch repair proficient (pMMR) tumours that have failed prior systemic therapy and are not candidates for curative surgery or radiation. The therapy received conditional approval from China’s National Medical Products Administration (NMPA) based on this data in December 2024.
The companies partnered to develop the combination therapy in November 2018. They are also evaluating another combination therapy through their partnership, looking at the efficacy of Tyvyt with surufatinib, a novel inhibitor of VEGFR, fibroblast growth factor receptor 1 (FGFR1) and colony-stimulating factor-1 receptor (CSF-1R).
PD-1/PD-L1 inhibitor Tyvyt was first granted approval by the Chinese agency in December 2018 for use in non-Hodgkin lymphoma. GlobalData predicts sales of Tyvyt to reach $1.48bn in 2030.
Elunate is a vascular endothelial growth factor receptor (VEGFR) inhibitor that received approval from the US Food and Drug Administration (FDA) in November 2023 for the treatment of metastatic colorectal cancer. Outside of China, Takeda Pharmaceuticals has marketing rights to the therapy, which is sold under the name Fruzaqla. GlobalData predicts sales of Elunate/Fruzaqla to reach $866m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
Eli Lilly had also established an ex-China partnership with Innovent for Tyvyt but this collaboration was dropped in October 2022 after the drug was rejected by the FDA some months prior. The therapy was rejected due to the application using only China collected pivotal data in non-small cell lung cancer.
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