Intensity Therapeutics, Inc. announced the presentation of final safety and efficacy data from its Phase 1/2 clinical trial of INT230-6 in sarcoma patients at the 2024 Connective Tissue Oncology Society (CTOS) meeting on November 18, 2024. The data showed a median overall survival (mOS) of 21.3 months for patients receiving INT230-6 alone, compared to a synthetic control of 6.7 months. This represents a significant improvement in survival for patients with relapsed, refractory, and metastatic sarcomas.
The Phase 1/2 study also demonstrated an increase in T-cell activation and a favorable safety profile for INT230-6. Dr. Albiruni Razak noted that INT230-6 causes cell death leading to tumor necrosis, improved cancer recognition by immune cells, and a systemic anti-cancer immune response. This mechanism results in T-cells entering the tumor microenvironment.
An overview of the ongoing INVINCIBLE-3 Study, a global randomized Phase 3 trial for soft tissue sarcoma, was also provided. This study is designed to enroll 333 patients and has received authorizations in the U.S., Canada, Europe, and Australia. The positive Phase 1/2 data supports the continued advancement of INT230-6 into late-stage clinical development.
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