Paz Vellanki, Vice President of Clinical Development at Precision for Medicine, shared on LinkedIn:
“The FDA recently granted Marengo Therapeutics a second Fast Track designation for invikafusp alfa, expanding from tumor mutational burden-high colorectal cancer to a tissue-agnostic indication across TMB-H solid tumors.
The designation covers patients with unresectable, locally advanced or metastatic disease that has progressed after prior treatment, including immune checkpoint inhibition, and who have no satisfactory treatment options.
Invikafulsp alfa is an investigational bispecific dual T-cell agonist designed to activate and expand specific T-cell populations through a mechanism distinct from PD-1 checkpoint inhibition.
Updated phase II STARt-001 results presented at ESMO 2026 reported an 18% objective response rate, 56% with tumor shrinkage and a 60% disease control rate among 62 evaluable patients across eight tumor types in a heavily pretreated population.
I’ll be watching what further studies show about patient selection and durability of response, and whether the evidence supports a tissue-agnostic development strategy.
Fast Track provides opportunities for closer FDA engagement and potential eligibility for expedited review. It does not establish clinical benefit, and more evidence is needed to determine where invikafusp alfa may fit in treating TMB-H solid tumors.”
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