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Marengo Therapeutics' Promising Data on Invikafusp Alfa

During the recent Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, Marengo Therapeutics shared groundbreaking interim results from the Phase 2 expansion study of their lead program, Invikafusp alfa (STAR0602). As a clinical-stage biotechnology firm focused on innovative immunotherapies for cancer treatment, Marengo has set high expectations with this latest presentation, underlining a growing interest within the medical community for novel treatment options.

Key Findings from the Clinical Trial

The study revealed compelling evidence of Invikafusp alfa’s effectiveness as a monotherapy in patients with PD-1 resistant, Tumor Mutational Burden-High (TMB-H) advanced solid tumors. Statistics highlighted include a 20% overall response rate (ORR) and an 80% disease control rate (DCR) across a variety of tumor types, including colorectal, lung, breast, gastric, gastroesophageal junction (GEJ), head and neck, and bladder cancers. Notably, 59% of patients exhibited tumor shrinkage in target lesions, encouraging signs of the drug's potential impact on patient health and quality of life.

Detailed Observations of Monotherapy Activity

The response rates varied across different tumor types, with gastrointestinal tumors observing a 28% ORR and a 78% DCR, while colorectal cancer patients experienced a 33% ORR and a 67% DCR. Non-small cell lung cancer samples indicated a 20% ORR alongside an 80% DCR. Impressive data was also noted in both immune checkpoint blockade (ICB)-naïve and experienced patients, signifying Invikafusp alfa’s applicability across various treatments and patient histories. Its activity extended beyond just TMB-H tumors to also include responsive elements in microsatellite stable (MSS) cancers, showcasing a broader therapeutic profile than initially anticipated.

Safety and Mechanistic Insights

Equally important, the safety profile of Invikafusp alfa remained consistent with expectations stemming from its unique action of selectively activating T cells. Adverse events reported were transient and manageable with standard supportive care, giving them a basis for regard in clinical environments. Evidence presented through paired biopsies illustrated significant expansion and enrichment of Vβ6⁺ T cells post-treatment, showcasing the drug's robust reprogramming abilities that enhance immune activation in the tumor microenvironment. Furthermore, a decrease in immune-suppressive factors was noted, which translated into tangible clinical benefits for patients receiving the treatment.

Future Directions

Marengo plans to continue its biomarker-enriched development strategy for Invikafusp alfa, solidifying its commitment to exploring the drug's capabilities in broader patient populations. To achieve this, they're currently conducting Phase 2 combination studies alongside Trodelvy, focusing on triple-negative breast cancer and HR⁺/HER2⁻ breast cancer outcomes.

Additionally, they are advancing through critical regulatory channels, having recently received Fast Track designation from the U.S. FDA for Invikafusp alfa in the treatment of metastatic colorectal cancer (mCRC), indicating the compound's potential significance in oncology.

Conclusion

With the presentation of these promising findings, Marengo Therapeutics is positioned to redefine the landscape of immunotherapies targeting hard-to-treat cancers. The results emphasize a commitment not just to effective treatments but also an ambitious drive towards overcoming existing barriers associated with PD-1 resistance in cancer therapies. The ongoing developments and research will be eagerly anticipated by many within the medical community, as they represent a hopeful avenue in the fight against cancer.

For additional information on Marengo Therapeutics and their innovative work, visit marengotx.com.