PR Newswire Clinical TrialsOriginal article
Marengo Therapeutics Receives Second U.S. FDA Fast Track Designation for Invikafusp Alfa, Expanding to a Tissue-Agnostic Indication Across Tumor Mutational Burden-High Solid Tumors That Progress After Prior Therapy, Including Checkpoint Inhibition
RegulatoryInvikafusp AlfaPositive
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Summary
Marengo Therapeutics received a second FDA Fast Track Designation for invikafusp alfa, expanding the tissue-agnostic indication to include tumor mutational burden-high solid tumors progressing after prior therapy. The designation is supported by monotherapy responses observed across multiple tumor types in the STARt-001 study.
Clinical Trial Data
Outcome Details
Second U.S. FDA Fast Track Designation received, expanding from TMB-H colorectal cancer to tissue-agnostic TMB-H solid tumors
Importance:7/10
Sentiment:
0.85
Fast Track DesignationImmuno-oncologyT-cell agonistTMB-HSolid tumorsSTARt-001
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Published by PR Newswire Clinical Trials on October 15, 2026 11:00 AM