Summit Therapeutics Announces Completion Of Enrollment In Its Phase III HARMONi Trial in 2L+ EGFRm NSCLC; FDA Grants Fast Track Designation For Ivonescimab In 2L+ EGFRm NSCLC
Summit Therapeutics Announces Completion Of Enrollment In Its Phase III HARMONi Trial in 2L+ EGFRm NSCLC; FDA Grants Fast Track Designation For Ivonescimab In 2L+ EGFRm NSCLC
Summit Therapeutics Inc. (NASDAQ:SMMT) ("Summit," "we," or the "Company") today announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy vs. placebo plus platinum-doublet chemotherapy with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). HARMONi completed enrolling patients from sites in North America, Europe, and China. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.FDA Grants Fast Track Designation for Ivonescimab in 2L+ EGFRm NSCLC
FDA授予Ivonescimab在二線+ EGFRm NSCLC的快速通道設計
HARMONi Completed Enrollment for Summit's First Sponsored Study Evaluating Ivonescimab
HARMONi完成了Summit首個贊助研究，評估Ivonescimab
Topline data from the HARMONi Trial Is Expected in Mid-2025
預計HARMONi試驗的最終數據將於2025年中期公佈
Summit Therapeutics Inc. (NASDAQ:SMMT) ("Summit," "we," or the "Company") today announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy vs. placebo plus platinum-doublet chemotherapy with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). HARMONi completed enrolling patients from sites in North America, Europe, and China. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
Summit Therapeutics Inc.（納斯達克：SMMT）（「Summit」，「我們」或「公司」）今日宣佈，我們已完成HARMONi臨床試驗的受試者招募，這是由Summit贊助的一項多區域III期研究，旨在評估ivonescimab聯合鉑雙組化療與使用第三代EGFR酪氨酸激酶抑制劑（TKI）治療後進展的表皮生長因子受體（EGFR）突變的晚期或轉移性非鱗狀非小細胞肺癌（NSCLC）的安慰劑聯合鉑雙組化療。HARMONi已完成在北美、歐洲和中國各地的患者招募。該臨床環境下的患者群體是PD-1單克隆抗體在先前全球第III期臨床試驗中未能成功的患者群體。
譯文內容由第三人軟體翻譯。