Intensity Therapeutics, Inc., in collaboration with The Swiss Group for Clinical Cancer Research SAKK, presented final data from the completed INVINCIBLE-2 Study and an overview of the ongoing INVINCIBLE-4 Study at the San Antonio Breast Cancer Symposium (SABCS) on December 12, 2024. The INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including triple-negative breast cancer (TNBC), demonstrated significant tumor-killing properties. Some patients experienced greater than 95% necrosis with a single intratumoral dose, alongside systemic immune activation.
The INVINCIBLE-4 Study, a randomized open-label, multicenter trial for early-stage, operable TNBC, is actively recruiting patients. This study aims to determine the clinical activity, safety, and tolerability of INT230-6 when administered before standard-of-care neoadjuvant immunochemotherapy. Seven sites in Switzerland have been activated for this trial, which is expected to enroll 54 patients.
Dr. Andreas Mueller highlighted the potential for INT230-6 to increase pathological complete response (pCR) rates in aggressive breast cancers without increased toxicity. Achieving a pCR is associated with a lower risk of disease recurrence, making this a critical endpoint for the INVINCIBLE-4 study.
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