What's Happening?
Marengo Therapeutics presented initial results from its STARt-002 clinical 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 Vβ6/10 T cells and early anti-tumor activity, with two confirmed partial responses. A recommended phase 2 dose has been established, and enrollment is ongoing for two expansion cohorts targeting triple-negative 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 options. The combination of immunotherapy and antibody-drug conjugates (ADCs) could offer a novel approach to treating this challenging disease. The trial's success could pave the way for further research and development in precision immunotherapy, potentially improving outcomes for patients with breast cancer. The study's findings also highlight the potential of Invikafusp alfa as an immunotherapy backbone, particularly when paired with ADCs.
What's Next?
Marengo Therapeutics will continue to enroll patients in the phase 2 expansion cohorts of the STARt-002 trial. The company aims to further evaluate the safety and efficacy of the Invikafusp alfa and TRODELVY® combination. As the trial progresses, additional data will be collected to confirm the initial findings and assess the long-term benefits of the treatment. The results could influence future clinical practices and regulatory approvals, potentially leading to new treatment options for patients with metastatic breast cancer.
