What's Happening?
Marengo Therapeutics has presented initial results from its STARt-002 phase 1b/2 trial at the 2025 San Antonio Breast Cancer Symposium. The study investigates the combination of Invikafusp alfa and TRODELVY®
in patients with metastatic breast cancer. Early findings indicate that the combination is well tolerated and shows biological activity across all dose levels. The trial demonstrated selective expansion of Vδ2/10 T cells and early anti-tumor activity in most patients. A recommended phase 2 dose has been established, and enrollment is ongoing for phase 2 expansion cohorts targeting metastatic triple-negative breast cancer and HR+/HER2– metastatic breast cancer.
Why It's Important?
The results from the STARt-002 trial are significant as they suggest a new potential treatment regimen for metastatic breast cancer, a condition with limited effective therapies. The combination of immunotherapy and antibody-drug conjugates (ADCs) could offer a novel approach to treating 'cold' tumors that are typically resistant to other forms of treatment. The study's findings could lead to improved outcomes for patients with difficult-to-treat breast cancer types, potentially extending survival and enhancing quality of life.
What's Next?
With the establishment of a recommended phase 2 dose, Marengo Therapeutics will continue enrolling patients in the phase 2 expansion cohorts. The ongoing research will focus on further evaluating the safety and efficacy of the drug combination. As the trial progresses, additional data will be collected to confirm the early promising results. If successful, this could pave the way for regulatory approval and broader clinical use of the combination therapy in treating metastatic breast cancer.
