Intensity Therapeutics has reported early promising results from its INVINCIBLE-4 trial of the intratumoral therapy INT230-6 in treating presurgical triple-negative breast cancer, with a pathological complete response observed in the first patient of Cohort A.

The trial involves administering two doses of INT230-6, spaced eight days apart, followed by standard immunochemotherapy, with initial signs of tumor necrosis and immune activation indicating potential effectiveness.

The primary endpoint of the study is the pCR rate, which is a strong indicator of long-term outcomes, and despite safety concerns, the early results are promising.

The INVINCIBLE-4 trial is a multicenter, open-label study authorized by Swiss Medic and the European Medicines Agency, conducted in collaboration with French and Swiss cancer research groups, aiming to improve surgical and long-term outcomes for triple-negative breast cancer patients.

The study plans to enroll up to 54 patients, comparing INT230-6 plus standard therapy versus standard therapy alone, with the goal of assessing whether the treatment can increase complete tumor responses.

INT230-6 is a proprietary intratumoral formulation that combines cisplatin, vinblastine sulfate, and a diffusion enhancer, designed to kill tumors and stimulate systemic immune responses without causing immunosuppression.

While the overall safety profile in Cohort A appears favorable, some patients experienced localized skin irritation, prompting a temporary pause in new patient enrollment to evaluate data and modify dosing.

The company emphasizes that the enrollment pause was voluntary and not mandated by regulators, with plans to resume with a modified dosing regimen to enhance safety and tolerability.

Looking ahead, the company remains optimistic about improving safety and efficacy in cancer treatments, aiming to turn deadly cancers into manageable chronic diseases, while acknowledging risks and uncertainties in clinical development.

Beyond this trial, the company has conducted other studies with INT230-6 in metastatic and locally advanced cancers, and is planning further trials, including a Phase 3 in soft tissue sarcoma.

Despite the safety concerns, experts highlight the potential of INT230-6 to improve treatment outcomes and cosmetic results, with the goal of increasing complete tumor responses and enhancing post-surgical appearance.