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An early T-cell trial stalled tumors in patients whose cancers had resisted immunotherapy

In an NIH-led phase 1/2 trial published in Nature Medicine, invikafusp alfa stopped progression in 16 of 27 patients at the optimal dose and shrank tumors in four. These are early results, not a cure.

Verified · Source: National Institutes of HealthOct 23, 2026 · 1 min read
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Illustrative photo of a technician at a microscope. This is not the START-001 trial team. Shixart1985 / Wikimedia Commons · CC BY 2.0

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An NIH-led phase 1/2 trial of invikafusp alfa, also called invika, has its first human results in Nature Medicine, the National Institutes of Health said on October 23. The study, START-001, was run with Mass General Brigham and Memorial Sloan Kettering. It enrolled people whose solid tumors had already resisted standard immunotherapy, including checkpoint drugs such as pembrolizumab.

At the optimal dose, disease stopped progressing in 16 of 27 patients, and tumors shrank in four. The NIH said the drug was well tolerated in that group. Invikafusp alfa is a protein built to activate a narrow set of tumor-infiltrating T cells rather than T cells across the board, a design meant to limit the harsh side effects of broader immune stimulants. These are early results in a small optimal-dose group. They are not a cure, and the release does not report how long the responses last or whether patients lived longer.

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