#United States #Chicago #Intensity Therapeutics #INT230-6 #INVINCIBLE-3

Presentation of Phase 3 INVINCIBLE-3 Study at ASCO 2025

Overview of the Study

Intensity Therapeutics, Inc. (Nasdaq: INTS) is excited to announce that its Phase 3 INVINCIBLE-3 clinical trial will be presented during the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. This presentation will take place at the McCormick Place in Chicago from May 30 to June 5, 2025. The study focuses on INT230-6, an advanced treatment aimed at metastatic soft tissue sarcomas.

Key Details of the INVINCIBLE-3 Trial

The presentation will feature a poster entitled "A Multicenter, Randomized, Global Phase 3 Study to Assess the Efficacy and Safety of Intratumoral (IT) INT230-6 (SHAO, Vinblastine, Cisplatin) as Monotherapy Compared with Standard of Care Systemic Chemotherapy in Adults with Locally Recurrent, Inoperable, or Metastatic Soft Tissue Sarcomas (STS) (INVINCIBLE-3)." This poster will highlight data from Sant P. Chawla, M.D., the Director of the Sarcoma Oncology Center of Southern California.

The trial aims to challenge conventional approaches to treatment by implementing a unique methodology that allows for direct intratumoral injections, which have demonstrated significant tumor necrosis and minimal residual cancer. The study protocol includes a rigorous design that emphasizes dosage based on tumor size and marks survival advantage as the main efficacy indicator.

Expectations and Impacts of the Trial

According to Dr. Chawla, “The INVINCIBLE-3 trial is breaking new ground in metastatic sarcoma.” With the new drug product INT230-6, there is optimism surrounding the outcomes, particularly regarding immune system response and tumor regression. The trials have shown promising results, with a disease control rate of 93% in sarcoma patients, coupled with median overall survival of 21.3 months, and a low incidence of adverse events related to treatment.

Future Perspectives

Lewis H. Bender, the founder, and CEO of Intensity Therapeutics, comments that the study is framed around a unique Phase 3 protocol that contrasts their localized therapy with best systemic standards based on previous trials. However, new patient enrollments have been temporarily halted until additional funding is secured, despite ongoing treatment for currently enrolled patients. The team remains vigilant in maintaining pharmacovigilance and operational monitoring to ensure the study's integrity during this phase.

The Innovation Behind INT230-6

INT230-6, which sits at the forefront of Intensity's research, employs a streamlined technology that aims to optimize drug delivery within tumors. This investigational drug is expertly engineered to mix with existing cytotoxic agents—cisplatin, vinblastine—along with a penetration enhancer molecule (SHAO) to direct the treatment precisely into the target tissue with minimal systemic side effects. The significant aspect of this treatment is its ability to invoke an immune response post-injection, which could fundamentally alter how clinicians approach the treatment of cancers that have been traditionally difficult to manage.

Conclusion

As the date approaches for the ASCO 2025 Annual Meeting, the oncology community will be closely monitoring the outcomes of the INVINCIBLE-3 trial. The potential implications of this study could open avenues for innovative treatment protocols in metastatic soft tissue sarcomas and possibly redefine patient prognoses for these challenging carcinomas. The clinical world eagerly anticipates the discussions that will stem from this study, aiming to make strides not only in precision medicine but also in expanding the frontiers of cancer treatment methodologies.