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和黃醫藥：自願性公告 - 和黃醫藥於美國臨床腫瘤學會全體大會系列會議 (ASCO Plenary Series) 公佈呋喹替尼 (fruquintinib) 二線治療胃癌的III期研究數據

HUTCHMED: VOLUNTARY ANNOUNCEMENT - HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in Second-Line Gastric Cancer at ASCO Plenary Series Session

香港交易所 ·  Feb 6 19:00
Summary by Moomoo AI
和黃醫藥（HUTCHMED）於2024年2月6日在美國臨床腫瘤學會全體大會系列會議（ASCO Plenary Series）上公佈了呋喹替尼聯合紫杉醇用於二線治療晚期胃癌患者的FRUTIGA III期研究數據。該研究是在中國35個臨床中心進行的1:1隨機、雙盲試驗，共703名患者參與。研究結果顯示，接受聯合療法的患者中位無進展生存期（PFS）為5.6個月，顯著優於接受紫杉醇單藥療法患者的2.7個月。客觀緩解率（ORR）亦顯著提高。雖然總生存期（OS）改善未達統計學意義，但在未接受後續抗腫瘤治療的患者中，OS改善達到統計學顯著。該研究支持呋喹替尼和紫杉醇聯合療法可能成為此類患者的有效二線治療選擇。呋喹替尼已於中國和美國獲批用於治療特定的轉移性結直腸癌患者，並於2023年4月獲中國國家藥品監督管理局受理用於治療晚期胃癌的新藥上市申請。
和黃醫藥（HUTCHMED）於2024年2月6日在美國臨床腫瘤學會全體大會系列會議（ASCO Plenary Series）上公佈了呋喹替尼聯合紫杉醇用於二線治療晚期胃癌患者的FRUTIGA III期研究數據。該研究是在中國35個臨床中心進行的1:1隨機、雙盲試驗，共703名患者參與。研究結果顯示，接受聯合療法的患者中位無進展生存期（PFS）為5.6個月，顯著優於接受紫杉醇單藥療法患者的2.7個月。客觀緩解率（ORR）亦顯著提高。雖然總生存期（OS）改善未達統計學意義，但在未接受後續抗腫瘤治療的患者中，OS改善達到統計學顯著。該研究支持呋喹替尼和紫杉醇聯合療法可能成為此類患者的有效二線治療選擇。呋喹替尼已於中國和美國獲批用於治療特定的轉移性結直腸癌患者，並於2023年4月獲中國國家藥品監督管理局受理用於治療晚期胃癌的新藥上市申請。
HUTCHMED announced the data of the FRUTIGA Phase III study of the FUQUINTINIC COMBINED URETHANOL for the 2-line treatment of patients with advanced gastric cancer at the ASCO Plenary Series on February 6, 2024 at the ASCO Plenary Series of the American Society of Clinical Oncology. The study was a 1:1 randomized, double-blind trial conducted in 35 clinical centers in China, involving 703 patients. The study results showed that the median progression-free survival (PFS) of patients receiving combination therapy was 5.6 months, significantly better than 2.7 months for patients receiving treatment with retinol monotherapy. The objective mitigation rate (ORR) was also significantly improved. Although overall survival (OS) improvements did not reach statistical significance, OS improvements were statistically significant in patients who did not receive subsequent...Show More
HUTCHMED announced the data of the FRUTIGA Phase III study of the FUQUINTINIC COMBINED URETHANOL for the 2-line treatment of patients with advanced gastric cancer at the ASCO Plenary Series on February 6, 2024 at the ASCO Plenary Series of the American Society of Clinical Oncology. The study was a 1:1 randomized, double-blind trial conducted in 35 clinical centers in China, involving 703 patients. The study results showed that the median progression-free survival (PFS) of patients receiving combination therapy was 5.6 months, significantly better than 2.7 months for patients receiving treatment with retinol monotherapy. The objective mitigation rate (ORR) was also significantly improved. Although overall survival (OS) improvements did not reach statistical significance, OS improvements were statistically significant in patients who did not receive subsequent antitumor therapy. The study supports that combined fluquinine and retinol therapy may be an effective second-line treatment option for such patients. Furuquinetine has been approved in China and the United States for the treatment of certain patients with metastatic colorectal cancer, and a new marketing application for a drug used to treat late-stage gastric cancer was accepted by the China National Drug Administration in April 2023.

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