What's Happening?
Marengo Therapeutics has announced initial results from its STARt-002 phase 1b/2 trial, which combines Invikafusp alfa and TRODELVY® for treating metastatic breast cancer. The study, presented at the 2025 San Antonio Breast Cancer Symposium, shows that
the combination is well tolerated and biologically active. The trial focuses on patients with previously treated metastatic triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer. Early findings indicate that the regimen induces robust expansion of Vβ6/10 T cells and shows early anti-tumor activity, with two confirmed partial responses. A recommended phase 2 dose has been established, and enrollment is ongoing in North America.
Why It's Important?
The results from the STARt-002 trial are significant as they offer a potential new treatment option for patients with metastatic breast cancer, particularly those with TNBC and HR+/HER2– subtypes. These findings could lead to advancements in precision immunotherapy, providing a new approach to treating immunologically 'cold' tumors. The combination of Invikafusp alfa and TRODELVY® leverages targeted T cell activation and ADC-mediated tumor killing, which could enhance treatment efficacy and improve patient outcomes. This development is crucial for the oncology field, as it may pave the way for more effective therapies that can overcome resistance to existing treatments.
What's Next?
As the STARt-002 trial progresses, further data will be collected to assess the full clinical potential of the Invikafusp alfa and TRODELVY® combination. The ongoing phase 2 expansion cohorts will provide more insights into the regimen's efficacy and safety. Marengo Therapeutics aims to continue exploring the use of Invikafusp alfa as an immunotherapy backbone, potentially expanding its application to other cancer types. The company is committed to advancing its research and development efforts to bring innovative treatments to patients with unmet medical needs. Future studies will focus on optimizing dosing strategies and understanding the long-term benefits of this novel therapeutic approach.
