Intensity Therapeutics, Inc. announced on January 28, 2025, that the Data Monitoring Committee (DMC) overseeing its ongoing Phase 3 INVINCIBLE-3 sarcoma study of INT230-6 has authorized the trial to continue without modification. This decision followed a periodic review of data collected from July to December 2024. The DMC's role is to confidentially review data for safety concerns.
The continuation of the trial without changes is a positive indicator regarding the safety profile of INT230-6 in the study population. The INVINCIBLE-3 Study is a global, open-label, randomized, controlled study designed to evaluate INT230-6 compared to standard of care chemotherapy in approximately 333 adult participants with soft tissue sarcoma. Its primary endpoints are overall survival and safety.
Intensity's President and CEO, Lewis H. Bender, expressed encouragement by the DMC's decision, emphasizing the potential of INT230-6 in an area of significant unmet medical need. The study continues to recruit patients in the U.S., Canada, and Europe, with authorizations also received from the European Medicines Agency and Australia's Therapeutic Goods Administration.
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