China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase II/III clinical study for Elunate (fruquintinib) combined with Tyvyt (sintilimab) as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China. The first patient was dosed this week.
Study Design and Objectives
The randomized, open-label, positive-controlled study is designed to compare the efficacy and safety of the Elunate-Tyvyt combination with axitinib or everolimus as monotherapy in second-line advanced RCC. The primary endpoint is progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 criteria.
Market Context and Previous Results
While five combined tumor immunotherapies have been approved in the US for first-line advanced RCC, none have been approved in China. However, the results of a Phase Ib/II study for the Elunate-Tyvyt combination in second-line RCC, published at the Chinese Society of Clinical Oncology (CSCO) annual meeting last year, demonstrated good efficacy and tolerable safety.
Elunate and Tyvyt Profiles
Elunate is a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor that received its first market approval in China in September 2018 for third-line treatment of colorectal cancer (CRC). The drug was added to the National Reimbursement Drug List (NRDL) at the beginning of 2020. HutchMed is partnering with Eli Lilly & Co. on the commercialization of the product in China, while retaining all rights outside the country.
Tyvyt is an innovative programmed-death 1 (PD-1) inhibitor jointly developed by Innovent and Eli Lilly & Co. (NYSE: LLY). The immunoglobulin G4 monoclonal antibody binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/PD-ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. In China, Tyvyt has been approved for six indications, including third-line treatment for relapsed or refractory classic Hodgkin’s lymphoma (cHL), first-line treatment for non-squamous non-small cell lung cancer (NSCLC), first-line treatment for squamous NSCLC, first-line treatment for hepatocellular carcinoma, first-line treatment for esophageal squamous cell carcinoma (ESCC), and first-line treatment for unresectable locally advanced, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma (GC/GEJC).
Future Outlook
With the initiation of this Phase II/III study, HutchMed is poised to advance the Elunate-Tyvyt combination therapy, addressing a significant unmet need in the treatment of renal cell carcinoma in China.-Fineline Info & Tech
