Intensity Therapeutics, Inc. announced on June 11, 2025, that the first few patients in its Phase 2 INVINCIBLE-4 study achieved high levels of tumor necrosis after just eight days of INT230-6 treatment. This occurred prior to the initiation of their standard-of-care regimen for early-stage, operable triple-negative breast cancer (TNBC). MRI scans showed significant tumor necrosis and evidence of immune activation.
The INVINCIBLE-4 Study is a randomized, open-label, multicenter trial recruiting patients in Switzerland and France, with an expected enrollment of 54 patients. The primary endpoint is pathological complete response (pCR), defined as the absence of live cancer in the primary tumor and affected lymph nodes. Patients are randomized to receive two doses of INT230-6 followed by standard-of-care, or standard-of-care alone.
Lewis H. Bender, President and CEO of Intensity, highlighted that TNBC patients achieving a pCR have a significantly improved event-free survival advantage. The company is encouraged by these early responses to INT230-6 before the standard immune-chemo regimen.
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