Intensity Therapeutics, Inc. Provides Update on the Phase 2 Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 Study

Core Insights - Intensity Therapeutics, Inc. provided an update on the Phase 2 INVINCIBLE-4 Study for presurgical treatment of triple-negative breast cancer, highlighting promising preliminary data on pathological complete response (pCR) rates and safety profile [1][2] Group 1: Study Overview - The INVINCIBLE-4 Study is a Phase 2 non-comparative, randomized open-label study analyzing the clinical activity, safety, and tolerability of INT230-6 combined with standard of care (SOC) immunochemotherapy in early-stage, operable triple-negative breast cancer [2] - Enrollment was paused in September 2025 due to skin irritations, but a protocol amendment was submitted in March 2026 to resume enrollment with adjusted dosing [1][2] - The expected total enrollment for the study is up to sixty-one (61) patients [1][2] Group 2: Efficacy Data - Preliminary results show that 71.4% (5 out of 7) of patients in Cohort A (receiving INT230-6 prior to SOC) achieved a pCR, compared to 33% (2 out of 6) in Cohort B (SOC alone) [1][2] - The pCR analysis is ongoing, and results are considered preliminary [1][2] Group 3: Safety Data - Cohort A experienced 14 grade 3 or higher adverse events (AEs), with only one being a common immune-related side effect, while Cohort B had 25 grade 3 AEs, including three grade 3 and one grade 4 [1][2] - There was a 44% reduction in grade 3 or higher AEs in Cohort A compared to Cohort B, indicating a favorable safety profile for INT230-6 combined with SOC [1][2] Group 4: Background on Triple-Negative Breast Cancer - Triple-negative breast cancer (TNBC) is an aggressive subtype with limited treatment options, accounting for approximately 11 to 17% of breast cancer cases [2] - The standard neoadjuvant treatment for TNBC includes systemic chemotherapy and pembrolizumab, with pCR rates ranging from 50% to 65% depending on tumor size [2] Group 5: INT230-6 Product Information - INT230-6 is designed for direct intratumoral injection and combines cisplatin and vinblastine sulfate with a diffusion enhancer, facilitating effective tumor penetration and immune engagement without immunosuppression [2] - The drug aims to improve local disease control and elicit systemic anti-tumor effects, representing a potential shift in the treatment paradigm for aggressive cancers [2]