Intensity Therapeutics' Phase 3 study, INVINCIBLE-3, evaluating INT230-6 for the treatment of soft tissue sarcoma, has been authorized to continue without modification following a review by the Data Monitoring Committee (DMC). This decision, announced by Intensity Therapeutics (INTS), comes after the DMC assessed data from July to December 2024.
The INVINCIBLE-3 study (NCT06263231) is a global, open-label, randomized, controlled trial designed to assess the efficacy and safety of INT230-6 when administered intratumorally, compared to standard-of-care (SOC) chemotherapy. The trial is enrolling patients with locally recurrent, inoperable, or metastatic soft tissue sarcoma who have progressed on prior therapies.
Study Design and Endpoints
The INVINCIBLE-3 study aims to enroll approximately 333 adult participants across multiple sites in the US, Canada, and Europe. Participants are randomized to receive either INT230-6 via intratumoral injection or one of three SOC therapies: pazopanib, trabectedin, or eribulin. The primary endpoint is overall survival, with secondary endpoints including safety and exploratory quality of life assessments.
Patients are stratified into three histological subtypes of soft tissue sarcoma: leiomyosarcoma, liposarcoma (including dedifferentiated, myxoid, round cell, and pleomorphic variants), and undifferentiated pleomorphic sarcoma. The comparator agents used in the study are all approved for sarcoma treatment in the US, Europe, Canada, and Australia.
INT230-6: Mechanism of Action
INT230-6, Intensity Therapeutics' lead investigational product, is designed for direct intratumoral injection. It comprises cisplatin and vinblastine sulfate, along with a penetration enhancer molecule (SHAO) to facilitate drug dispersion within tumors. This formulation aims to achieve local disease control, direct tumor killing, and the release of tumor-specific neoantigens, potentially leading to systemic anti-tumor effects without immunosuppression.
Prior Clinical Data
In November 2024, Intensity Therapeutics presented Phase 1/2 data for INT230-6 at the Connective Tissue Oncology Society Meeting (CTOS). The data showed a median overall survival of 21.3 months for patients receiving INT230-6 alone, compared to 6.7 months in a synthetic control group. The study also demonstrated increased T-cell activation and a favorable safety profile.
Management Commentary
"We are encouraged by the continuation of the trial and continue to believe that INT230-6 represents important potential in a treatment area that has significantly unmet medical need," said Lewis H. Bender, President and CEO of Intensity Therapeutics. He also noted the company's excitement about the contracts with sarcoma-focused hospitals and the ongoing patient recruitment for both the Phase 3 sarcoma trial and the Phase 2 presurgical breast cancer trial.
