#United States #Cambridge #Marengo Therapeutics #Invikafusp Alfa #Trodelvy

Marengo Therapeutics Unveils Initial Findings from STARt-002

Marengo Therapeutics, Inc., a biotechnology company specializing in precision immunotherapy, has made significant strides in the fight against metastatic breast cancer. During the recent San Antonio Breast Cancer Symposium held from December 9-12, 2025, the company presented early results from its STARt-002 trial, focusing on the combination of Invikafusp alfa (also known as Invika) and TRODELVY® (sacituzumab govitecan-hziy).

Promising Clinical Results

The STARt-002 trial, which is in its phase 1b/2 stage, aims to evaluate the efficacy and safety of this innovative combination therapy for patients with previously treated metastatic breast cancer. Early findings suggest that this regimen not only shows a favorable safety profile, consistent with the known effects of each drug but also exhibits early signs of anti-tumor activity among the majority of patients involved in the study.

Dr. Steven Isakoff, a leading authority from the Massachusetts General Hospital Cancer Center, emphasized the scientific merit of these results. He stated, "The combination of Invika with TRODELVY® is compelling - it pairs targeted T cell activation with ADC-mediated tumor cell death. Seeing an increase in Vβ6/10 T cells alongside early tumor responses reinforces the potential of this treatment.”

Understanding the Mechanism of Action

Pharmacodynamic analyses indicate that Invika effectively maintains its action mechanism when combined with TRODELVY®. This results in a robust activation of Vβ6/10 T cells, a crucial component of the immune response, in patients suffering from triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer. In fact, almost all patients treated demonstrated early anti-tumor activity, with two cases confirming partial responses to the therapy.

The recommended dose for the upcoming phase 2 expansion cohorts has been established, with ongoing enrollment for patients at several cancer centers throughout North America. These cohorts specifically target individuals with metastatic TNBC and HR+/HER2– breast cancer, evidencing the robust direction of this clinical investigation.

Innovative Approaches to Treatment

Kevin Chin, Chief Medical Officer at Marengo Therapeutics, shared his optimism regarding these initial data. He noted, "Invikafusp has previously shown promise as a single agent in tumors resistant to PD-1 inhibitors. These results further substantiate its position as a potential backbone in immunotherapy, particularly in combination with ADCs, to tackle immunologically 'cold' tumors like breast cancer. We are excited about the safety, pharmacodynamics, and early clinical activity gleaned from this Invika and TRODELVY® regimen. We look forward to revealing more about the clinical potential as STARt-002 progresses through Phase 2."

Future Directions

The implications of the STARt-002 trial are being keenly observed, as it could pave the way for a groundbreaking approach in breast cancer treatment. The investigation is not merely exploring a new combination of therapies but is also examining the foundational mechanisms of immune response related to breast cancer. The results from this trial could ultimately shape future strategies for managing this challenging disease.

Presentation Overview

• - Presentation Title: Initial clinical and pharmacology results from STARt-002
• - Abstract Number: LBA 3714
• - Presentation Date/Time: December 11, 2025, 5:00 PM - 6:30 PM
• - Trial-In-Progress Information: STARt-002 (NCT06827613) focuses on the combination of invikafusp alfa and TRODELVY® in patients with metastatic breast cancer.

While the combination of Invikafusp alfa and TRODELVY® remains investigational and has not been approved by healthcare authorities, the early results provide a hopeful prospect for breast cancer patients and underline Marengo Therapeutics' commitment to innovating cancer care.