On December 12, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy for oncology and inflammation & immunology (I&I), reported initial clinical results from its ongoing STARt-002 phase 1b/2 trial during a late breaking presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12.

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Early findings from the combination study of Invikafusp alfa (Invika) and TRODELVY (sacituzumab govitecan-hziy; SG) suggest that this novel regimen, which leverages two key modalities (immunotherapy and ADCs), is well tolerated and biologically active across all dose levels evaluated. The safety profile of the combination was consistent with the known profiles of each agent.

"The early safety and pharmacodynamic data from STARt-002 are highly encouraging," said Steven Isakoff, M.D., Ph.D., Director of Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center. "The combination of Invika with TRODELVY is scientifically compelling — pairing targeted T cell activation with ADC-mediated tumor killing. Seeing consistent Vβ6/10 expansion alongside early tumor responses reinforces the potential of this regimen to meaningfully benefit patients with metastatic breast cancer, and I look forward to the results from the ongoing phase 2 cohorts."

Pharmacodynamic analyses confirmed that Invika maintains its mechanism of action in combination with Trodelvy, inducing robust and selective expansion of Vβ6/10 T cells in patients with previously treated metastatic triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer. Evidence of early anti-tumor activity was observed in almost all patients treated with this combination, including two confirmed partial responses.

A recommended phase 2 dose (RP2D) has now been established, and enrollment is ongoing in two phase 2 expansion cohorts for people with metastatic triple-negative breast cancer (TNBC) and HR+/HER2– metastatic breast cancer at select cancer centers across North America.

"Invikafusp has already demonstrated promising single-agent activity in PD-1-resistant tumors, including breast cancer," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "These initial findings further support Invika as a potential immunotherapy backbone, particularly when paired with ADCs to treat immunologically ‘cold’ tumors such as breast cancer. We are encouraged by the safety, pharmacology, and early signs of clinical activity observed with the Invika and SG regimen and look forward to understanding the full clinical potential of this treatment regimen as STARt-002 advances through Phase 2."

Additional presentation details are as follows:

Presentation: Initial clinical and pharmacology results from START-002
Abstract Number: LBA 3714
Presentation Number: PS4-06-28
Poster Presentation Date/Time: Thursday, December 11, 2025, 5:00 PM – 6:30 PM
Presentation: Trial-in-progress: START-002
Abstract Number: 2124
Presentation Number: PS5-09-16
Poster Presentation Date/Time: Friday, December 12, 2025, 12:30 PM – 2:00 PM
The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established.

(Press release, Marengo Therapeutics, DEC 12, 2025, View Source [SID1234661407])