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Intensity Therapeutics, Inc. Announces First Patient Dosed in its Global Randomized, Phase 3 Study (INVINCIBLE-3) in Metastatic Soft Tissue Sarcoma
Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy SHELTON,
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy\nSHELTON, Conn., July 9, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (\"Intensity\" or \"the Company\") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, announces that the first U.S. patient has been dosed in the Company's Phase 3 study to treat metastatic sarcoma (NCT06263231). The trial is a superiority study testing INT230-6 as monotherapy compared to the investigator's choice of three current standard-of-care systemic chemotherapy drugs in second or third-line metastatic, recurrent, or inoperable soft tissue sarcomas (\"STS\").\n\n \n \n \n \n \n \n\n \nThe global Phase 3 study is expected to enroll approximately 333 patients. The primary endpoint is overall survival. For every three patients treated, two will receive INT230-6, and one will receive the standard of care. STS subtypes being enrolled are leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. The Phase 3 initiation follows reported data from the Company's Phase 1/2 trial, where INT230-6 showed tumor-killing and immune-activating properties with increased survival in metastatic disease.\n\"We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe. Over the next several months, we anticipate initiating sites in eight countries. Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months,\" said Intensity Therapeutics' Founder, Chairman, and CEO, Lewis H. Bender. \"During our phase 1/2 metastatic dose escalation study, in a sarcoma population that had progressed following a median of 3 lines of therapy, we reported a median overall survival of 21.3 months with our drug alone. Patients, their caregivers, and physicians worldwide desperately need improved treatment options and we are excited to have finally begun testing our new approach in Phase 3. I want to take this opportunity to thank our dedicated team for getting us to this tremendous milestone.\...