FDA grants Fast-Tracks designation to Invikafusp Alfa for Previously Treated TMB-High Solid Tumors
“A second Fast Track Designation, now in a pan-tumor setting, reinforces our conviction that invikafusp alfa can become a next-generation, tissue-agnostic immuno-oncology backbone,” said Ke Liu, M.D., Ph.D., Chief Development Officer of Marengo Therapeutics. “Across multiple clinical data sets, invikafusp alfa has shown encouraging monotherapy activity in heavily pretreated patients across tumor types that were either insensitive to checkpoint inhibitors or progressed after PD-1–directed therapy. In parallel, we are evaluating invikafusp alfa in combination with standard-of-care therapies, including an antibody-drug conjugate, to support its potential in earlier lines of therapy. We look forward to presenting Phase 2 STARt-001 data at ESMO later this month.”
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