{"id":20101,"date":"2025-03-19T03:20:17","date_gmt":"2025-03-19T03:20:17","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/innovent-and-hutchmed-jointly-announce-that-the-frusica-2-phase-2-3-study-of-sintilimab-and-fruquintinib-combination-has-met-its-primary-endpoint-in-advanced-renal-cell-carcinoma-in-china\/"},"modified":"2025-03-19T03:20:17","modified_gmt":"2025-03-19T03:20:17","slug":"innovent-and-hutchmed-jointly-announce-that-the-frusica-2-phase-2-3-study-of-sintilimab-and-fruquintinib-combination-has-met-its-primary-endpoint-in-advanced-renal-cell-carcinoma-in-china","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=20101","title":{"rendered":"Innovent and HUTCHMED Jointly Announce that the FRUSICA-2 Phase 2\/3 Study of Sintilimab and Fruquintinib Combination Has Met Its Primary Endpoint in Advanced Renal Cell Carcinoma in China"},"content":{"rendered":"

SAN FRANCISCO<\/span> and\u00a0SUZHOU, China<\/span><\/span>, March 19, 2025<\/span><\/span> \/PRNewswire\/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China<\/span>) Limited (“HUTCHMED”) (Nasdaq\/AIM:HCM; HKEX:13), today jointly announce that the FRUSICA-2 Phase 2\/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China<\/span> has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR).<\/p>\n

The combination of sintilimab and fruquintinib received conditional approval from China’s<\/span> National Medical Products Administration (NMPA) for the treatment of 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, based on data from the FRUSICA-1 study\u00a0(NCT03903705<\/a>).<\/p>\n

The FRUSICA-2 study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC\u00a0(NCT05522231<\/a>). In addition to the primary endpoint PFS, the combination also demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). Full results will be submitted for presentation at an upcoming scientific conference.<\/p>\n

Prof Dingwei Ye<\/span> of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study<\/b>, said:\u00a0“The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Targeted therapy remains an indispensable and crucial component in systemic treatment of advanced RCC in China<\/span>. Optimizing the selection of targeted therapy, either as monotherapy or in combination with immunotherapy, for individual patients is a key focus of clinical interest. The results from the FRUSICA 2 study underscore the potential of the sintilimab and fruquintinib combination to address the pressing medical needs of patients with this challenging disease.”<\/p>\n

Prof Zhisong He<\/span> of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study<\/b>, said: “The positive results from this Phase 3 study of the sintilimab and fruquintinib combination represent a significant advancement in the treatment of advanced renal cell carcinoma. We are optimistic about the clinical implications of the findings as we strive to provide more effective treatment options for patients who may not have had adequate responses to previous therapies.”<\/p>\n

Dr Hui Zhou<\/span>, Senior Vice President of Innovent<\/b>, stated: “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 sintilimab and fruquintinib 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.”<\/p>\n

Dr Michael Shi<\/span>, Head of R&D and Chief Medical Officer of HUTCHMED, stated: <\/b>“The encouraging\u00a0results from our study provide clear evidence for the combination of fruquintinib and sintilimab as a viable new treatment option for advanced renal cell carcinoma patients who have progressed on previous therapy. This not only reaffirms our commitment to advancing cancer therapies but also represents an important step forward in addressing unmet medical needs within this patient population.\u00a0I extend my heartfelt gratitude to the patients and investigators who participated in this research; their contributions have been vital to our success. We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months.”<\/p>\n

About Kidney Cancer and RCC<\/b><\/p>\n

It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[i]<\/sup> In China<\/span>, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[ii]<\/sup> Approximately 90% of kidney tumors are RCC.<\/p>\n

About Sintilimab<\/b><\/p>\n

Sintilimab, marketed as TYVYT\u00ae<\/sup> (sintilimab injection) in China<\/span>, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which 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.[iii]<\/sup><\/p>\n

In China<\/span>, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT\u00ae <\/sup>(sintilimab injection) includes:<\/p>\n