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.
Published by GSM · USA (original Chinese edition)
Photo: 实验室研究人员使用显微镜（资料照片，Artem Podrez 摄，Pexels 免费授权）
