China approves HUTCHMED and Innovent combo therapy for advanced kidney cancer
HUTCHMED (NASDAQ:HCM) and Innovent Biologics jointly announced that China’s National Medical Products Administration has approved the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) for the treatment of adults with advanced kidney cancer.
The regulatory clearance specifically targets patients with locally advanced or metastatic renal cell carcinoma (RCC) who have experienced disease progression or treatment failure on prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies.
To qualify for the regimen, patients must not have received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapies in the initial first-line treatment setting.
The NMPA's decision represents a critical portfolio expansion for both firms, providing a dual-mechanism approach that pairs HUTCHMED's highly selective oral VEGFR inhibitor with Innovent's PD-1 monoclonal antibody.
Renal cell carcinoma accounts for roughly 90% of all kidney cancer diagnoses, a disease category that saw an estimated 74,000 new cases in China in 2022 alone, representing a substantial unmet medical need for secondary treatment options.
Data from the randomized, active-controlled registration study, dubbed FRUSICA-2, served as the primary clinical foundation for the regulatory submission.
The trial evaluated the combination therapy directly against standard monotherapies, specifically axitinib or everolimus, in the second-line setting.
The trial successfully met its primary endpoint of progression-free survival (PFS) as evaluated by a blinded independent central review.
Results demonstrated that the combination therapy reduced the relative risk of disease progression or death by 63% compared to the single-agent active controls.
Furthermore, patients treated with the ELUNATE and TYVYT regimen achieved a median progression-free survival of 22.2 months, a significant extension compared to the 6.9 months observed in the monotherapy benchmark arms.
The safety profile observed throughout the multi-center trial remained consistent with the historically established clinical parameters of each individual therapeutic agent, with no new or unexpected safety signals reported.
