ESMO 2025 | Clinical activity of invikafusp alfa, a TCR bsAb, monotherapy in solid tumors

Right, so the START-001 study examines a new agent called invikafusp alfa. So what this is, is a T-cell engager. It engages the V-beta-6, V-beta-10 epitope on the T-cell receptor, which is enriched in tumor-infiltrating lymphocytes. Now, this agent also has interleukin-2 which it delivers as a payload and so essentially it’s binding to these T cell receptors enriched in tumor infiltrating lymphocytes and delivering IL-2 and activating these T cells. Now it’s not a bi-specific T cell engager, so it’s not binding to a tumor antigen at the moment, but there are plans to potentially do that, further modify this drug. But at the moment, with this agent, it has been looked at in this study in tumor mutation burden high patients, that’s 10 or more mutations, or MSI high patients. So in this patient population, it was 48 patients across all solid tumors, mostly TMB high, some MSI high. Two-thirds of them had progressed after a previous immune checkpoint inhibitor, where we don’t have great immunotherapy options. In this patient population, there was a response rate of around 20-21%. So this is very promising for this T-cell engager. It did have toxicities of cytokine release syndrome, which is typical for T-cell engagers. But preliminarily, very promising evidence. And indeed, this agent is being examined some more in a phase two study of colorectal cancer, where there was some more interesting activity seen. So we’ll await more data. But I think that this agent looks very promising in this study.

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