Intensity Therapeutics, Inc. provided an update on September 10, 2025, regarding its Phase 2 INVINCIBLE-4 study for presurgical triple-negative breast cancer, reporting a pathological complete response (pCR) in the first patient evaluated in Cohort A. Patients in this cohort receive two doses of INT230-6 followed by standard of care immunochemotherapy. Additionally, patients treated with INT230-6 continue to show significant necrosis after two doses, prior to initiating standard of care.
Despite the positive efficacy signal, new patient enrollment in the INVINCIBLE-4 study has been paused. This pause is to implement modifications aimed at resolving localized skin irritation observed in some INT230-6 patients. The company stated that the safety profile in Cohort A generally looks favorable, but this issue requires attention.
The observation of a pCR is a strong indicator of treatment efficacy, as it signifies the absence of live cancer. However, the temporary halt in enrollment due to a safety concern, even if localized, introduces uncertainty and could delay the trial's progress.
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