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News
A promising cancer drug just got a bigger green light. The FDA has granted invikafusp alfa (STAR0602) an expanded fast track designation covering all tumor mutational burden–high (TMB-H) solid tumors that have progressed after prior therapy, including checkpoint inhibitors. This builds on its earlier designation for colorectal cancer and marks it as the first T-cell agonist with tissue-agnostic fast track status selected by biomarker.
A cancer immunotherapy just leveled up its FDA status. The FDA has granted invikafusp alfa (STAR0602) an expanded fast track designation for patients with unresectable, locally advanced, or metastatic TMB-H solid tumors that have progressed after prior therapy — including immune checkpoint inhibitors. This new tissue-agnostic designation builds on its January 2025 fast track status for TMB-H colorectal cancer (CRC), and Marengo Therapeutics believes it's the first immuno-oncology T-cell agonist to earn fast track status for a biomarker-selected, pan-tumor population.
The designation was supported by early data from the phase 1/2 START-001 trial, which enrolled patients across a wide range of tumor types — including colorectal, gastric, breast, urothelial, endometrial, and lung cancers. In initial phase 2 data presented at the 2025 ESMO Congress, invikafusp alfa showed meaningful activity even in heavily pretreated patients resistant to checkpoint blockade.
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Why it matters: For patients with TMB-H tumors who've exhausted standard options — including checkpoint inhibitors — treatment choices are slim. Invikafusp alfa's tissue-agnostic fast track status could accelerate its path to approval across multiple cancer types, potentially offering a new immunotherapy backbone for a broad and underserved patient population.
