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 from TMB-H colorectal cancer to a tissue-agnostic indication for TMB-H solid tumors progressing after prior therapy. The designation is supported by monotherapy responses across multiple tumor types in the STARt-001 study.

Clinical Trial Data

Outcome Details

Second U.S. FDA Fast Track Designation received for Invikafusp Alfa expanding to tissue-agnostic indication in TMB-H solid tumors post-prior therapy

Importance:7/10

Sentiment:

0.80

Fast Track DesignationImmuno-oncologyT-cell agonistTMB-HSolid tumorsSTARt-001 study

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Published by PR Newswire Biotech on October 15, 2026 11:00 AM

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