Invikafusp alfa is a novel immunotherapy showing promise for advanced colorectal cancer, especially in patients resistant to PD-1 inhibitors. Developed by Marengo Therapeutics, it is a selective dual T-cell agonist that activates and expands specific T cells (Vβ6 and Vβ10), boosting the immune system’s ability to attack cancer cells. Unlike PD-1 inhibitors, which release immune “brakes,” invikafusp acts like a “gas pedal” to stimulate targeted immune responses.
In the Phase 1/2 STARt-001 trial, 25% of patients with high tumor mutational burden (TMB-H) colorectal cancer resistant to PD-1 therapy achieved objective responses, and 63% experienced partial response or stable disease. More than half showed tumor shrinkage. Side effects were generally mild and manageable, typical of T-cell activation.
The FDA has granted Fast Track designation for invikafusp alfa in unresectable or metastatic TMB-H colorectal cancer. For patients who have exhausted standard treatments, this therapy offers new hope for effective immune-based cancer control.