DMC Recommends Continuation of Phase 3 INVINCIBLE-3 Sarcoma Study

Photorealistic illustration of sarcoma - Generated with Google Gemini AI

The Data Monitoring Committee (DMC) for the ongoing phase 3 INVINCIBLE-3 study of INT230-6 (NCT06263231) for the potential treatment of patients with sarcoma has agreed that the study should continue without modification after reviewing data covering the 6 months from July to December 2024.¹

"The Data Monitoring Committee is designed to confidentially review data to determine whether safety concerns with the data collected to date exist,” Lewis H. Bender, Intensity's president and chief executive officer, said in a press release. “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. We look forward to continuing enrollment and to providing further updates as they develop.”

INVINCIBLE-3 is a global, multicenter, randomized, phase 3, superiority study evaluating treatment with INT230-6 alone vs the investigator's choice of 3 current standard-of-care (SOC) systemic chemotherapy drugs in second- or third-line metastatic, recurrent, or inoperable soft tissue sarcomas.²

The study plans to enroll approximately 333 patients, with a primary end point of overall survival. Subtypes of soft tissue sarcomas being enrolled include leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

Patients aged 18 years and older with histologically proven, unresectable, locally advanced, or metastatic soft tissue sarcoma are eligible for enrollment in the study if they have measurable disease per RECIST 1.1 criteria, at least 1 target tumor suitable for injection using routine image guidance 2 cm or more measurable by CT or MRI, adequate organ function, and an ECOG performance status of 0 to 2. Patients must also have received at least 1 line of therapy for their sarcoma and are required to have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused.

Those who have received more than 2 prior regimens for unresectable, locally advanced, or metastatic soft tissue sarcoma are not eligible for enrollment.

For every 3 patients treated, 2 patients will be given treatment with INT230-6, and 1 will receive the SOC. Patients will be randomized following screening and eligibility confirmation. With the trial being a survival study, there is no crossover allowed between SOC and INT230-6.¹

In July 2024, the phase trial dosed its first patient from the Unites States with metastatic sarcoma. Now, the INVINCIBLE-3 study is actively recruiting patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. Regulatory authorizations for the study have been obtained in the United States, Canada, Europe, and Australia.

REFERENCES:

1. Drug monitoring committee authorizes continuation of Intensity Therapeutics' ongoing global randomized phase 3 sarcoma trial ("INVINCIBLE-3 study") following periodic review. News release. Intensity Therapeutics, Inc. January 28, 2025. Accessed January 28, 2025. https://tinyurl.com/5t45643z

2. A study to investigate efficacy & safety of INT230-6 compared to US standard of care in adults with soft tissue sarcomas (INVINCIBLE-3) (INVINCIBLE-3). ClinicalTrials.gov. Accessed January 1, 2025. Updated January 28, 2025. https://clinicaltrials.gov/study/NCT06263231?tab=table