Intensity Therapeutics Reports Early Positive Data in TNBC Trial, Resumes Enrollment
Event summary
- Intensity Therapeutics reported preliminary data from its Phase 2 INVINCIBLE-4 study, showing 71.4% pathological complete response (pCR) in Cohort A (INT230-6 + SOC) vs. 33% in Cohort B (SOC alone).
- Enrollment was paused in September 2025 due to skin irritations in Cohort A but resumed in March 2026 after a protocol amendment.
- Grade 3 or higher adverse events were 44% lower in Cohort A compared to Cohort B.
- The study aims to enroll up to 61 patients, with 14 treated so far.
The big picture
Intensity Therapeutics' INVINCIBLE-4 study represents a strategic push into the presurgical triple-negative breast cancer space, where pCR is a critical endpoint for accelerated approval. The company's non-covalent drug-conjugation technology aims to address the high toxicity and unmet medical needs in TNBC treatment. The resumption of enrollment after protocol adjustments highlights the company's agility in navigating clinical trial challenges.
What we're watching
- Clinical Efficacy
- Whether the higher pCR rate in Cohort A can be sustained with the adjusted dosing protocol.
- Regulatory Pathway
- The pace at which Intensity Therapeutics can secure accelerated approval based on pCR data.
- Safety Profile
- How the reduced adverse events in Cohort A will impact long-term patient outcomes and regulatory reviews.
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