FDA授予Marengo癌症免疫疗法第二次快速通道资格 适用范围扩至多癌种高突变负荷实体瘤
马萨诸塞州剑桥——临床阶段生物技术公司Marengo Therapeutics于10月15日宣布，美国食品药品监督管理局（FDA）已授予其在研癌症免疫疗法invikafusp alfa第二次快速通道资格（Fast Track），适用人群为既往治疗（包括免疫检查点抑制剂）后病情进展、且无满意治疗方案的不可切除、局部晚期或转移性高肿瘤突变负荷（TMB-H）实体瘤患者。
此次认定把该药的快速通道范围从单一癌种扩展到不限组织来源：2025年1月，该药首次获得快速通道资格时针对的是TMB-H结直肠癌；本次认定覆盖符合条件的各类实体瘤。公司称，这是肿瘤免疫领域的T细胞激动剂首次在以生物标志物界定、不限组织来源的适应症上获得此类认定。
认定依据来自正在进行的1/2期STARt-001研究：该药单药治疗在结直肠、胃、乳腺、尿路上皮、子宫内膜、胃食管、头颈与肺等多个癌种中观察到客观缓解。更新的2期数据将于10月23日在马德里举行的欧洲肿瘤内科学会（ESMO）2026年大会上以口头报告形式公布。
公司首席开发官刘科（Ke Liu）表示，第二次快速通道资格强化了公司对该药的信心。快速通道是FDA为加速严重疾病药物开发与审评设立的机制，获认定药物可与FDA更频繁沟通，并可能适用滚动审评等安排；该资格不等于药物已获批准上市。
FDA Grants Marengo's Cancer Immunotherapy a Second Fast Track Designation, Expanding to TMB-High Solid Tumors Across Cancer Types
CAMBRIDGE, Mass. — Clinical-stage biotechnology company Marengo Therapeutics announced on October 15 that the U.S. Food and Drug Administration has granted a second Fast Track designation to its investigational cancer immunotherapy invikafusp alfa, for patients with unresectable, locally advanced or metastatic solid tumors with high tumor mutational burden (TMB-H) that have progressed after prior therapy, including immune checkpoint inhibition, and who have no satisfactory treatment options.
The designation expands the drug's Fast Track scope from a single cancer type to a tissue-agnostic setting: its first designation, granted in January 2025, covered TMB-H colorectal cancer. The company said it is believed to be the first immuno-oncology T-cell agonist to receive Fast Track designation in a biomarker-defined, tissue-agnostic indication.
The decision is supported by the ongoing Phase 1/2 STARt-001 study, in which the drug as monotherapy produced objective responses across colorectal, gastric, breast, urothelial, endometrial, gastroesophageal, head and neck, and lung cancers. Updated Phase 2 results will be presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid on October 23.
Chief development officer Dr. Ke Liu said the second designation, now in a pan-tumor setting, reinforces the company's conviction in the drug. Fast Track is an FDA program intended to facilitate the development and review of drugs for serious conditions; the designation does not mean the drug has been approved.
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