An early study of invikafusp alfa, or invika, recorded no disease progression in 16 of 27 participants treated at optimal biological doses across its two phases, NIH reported on Oct. 23, 2026. The Nature Medicine abstract identifies START-001 as a phase 1/2 trial of the drug alone in people with mostly immune checkpoint blockade-resistant, antigen-rich solid tumors. Its results are reported as of March 12, 2025.
Four of the 27 had greater than 30% decreases in the size of targeted tumors, NIH reported. The paper’s abstract gives a 14.8% objective response rate for the optimal-biological-dose group, including confirmed partial responses. The four-person response count is narrower than the 16-person no-progression count.
Invika is designed to stimulate a narrow subset of T cells rather than T cells broadly, NIH explains. The abstract reports expansion of its targeted Vβ6/Vβ10 T-cell subsets. NIH described treatment at the optimal doses as well tolerated and said flu-like side effects were generally manageable. The abstract identifies cytokine release syndrome as the most common treatment-related adverse event, mainly grades 1 and 2, and reports two reversible dose-limiting toxicities.
NIH quoted co-first author Nicholas Tschernia warning that signs of immune activity do not always translate into patient benefit at this stage. The abstract calls the phase 2 findings initial and supports further evaluation. NIH’s report does not give a duration of disease control for the 16-person group.
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