Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with the primary endpoint of progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), having been met.
Study Design and Results
The randomized, open-label, positive-controlled study compared the efficacy and safety of the fruquintinib and sintilimab combination against axitinib or everolimus alone in second-line advanced RCC. The trial demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR).
Drug Profiles
Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2, and -3). It is marketed under the name Fruzqala by Takeda outside China and as Elunate by Eli Lilly in collaboration with HutchMed in China. The drug received approval in the US in November 2023 for previously treated metastatic colorectal cancer (CRC) and is also registered in the European Union, Switzerland, Canada, Japan, the UK, Argentina, Australia, and Singapore.
Sintilimab, a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company, has seven indications included in China’s National Reimbursement Drug List (NRDL). The combination of sintilimab and fruquintinib was conditionally approved in China in December last year for treating patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.-Fineline Info & Tech
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