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在二线+ EGFRm NSCLC的快速通道设计
HARMONi Completed Enrollment for Summit's First Sponsored Study Evaluating Ivonescimab
HARMONi完成了Summit首个赞助研究，评估Ivonescimab
Topline data from the HARMONi Trial Is Expected in Mid-2025
预计HARMONi试验的最终数据将于2025年中期公布
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.（纳斯达克：SMMT）（“Summit”，“我们”或“公司”）今日宣布，我们已完成HARMONi临床试验的受试者招募，这是由Summit赞助的一项多区域III期研究，旨在评估ivonescimab联合铂双组化疗与使用第三代EGFR酪氨酸激酶抑制剂（TKI）治疗后进展的表皮生长因子受体（EGFR）突变的晚期或转移性非鳞状非小细胞肺癌（NSCLC）的安慰剂联合铂双组化疗。HARMONi已完成在北美、欧洲和中国各地的患者招募。该临床环境下的患者群体是PD-1单克隆抗体在先前全球第III期临床试验中未能成功的患者群体。