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A novel drug duo is turning heads in breast cancer treatment. Interim data from the STARt-002 trial show that combining invikafusp alfa — a first-in-class T-cell activator — with sacituzumab govitecan produced responses in roughly 25–28% of patients with metastatic triple-negative or HR+/HER2– breast cancer, with no new safety signals. The results hint at a potential path to bringing immunotherapy to cancers that historically don't respond to it.
A first-in-class T-cell booster teams up with a proven ADC in metastatic breast cancer
Researchers are testing a creative new strategy for metastatic breast cancer: pair a drug that activates the immune system with one that delivers chemotherapy directly to tumor cells. Interim data from the phase 1b/2 STARt-002 trial, presented at the 2026 SITC Annual Meeting, show that invikafusp alfa (a dual T-cell agonist) combined with sacituzumab govitecan (Trodelvy) produced objective response rates of 28% in triple-negative breast cancer (TNBC) and 25% in HR+/HER2– breast cancer among heavily pretreated patients — with disease control rates of 67% and 80%, respectively.
The rationale is straightforward: sacituzumab govitecan kills tumor cells in a way that may flag them for immune attack, while invikafusp alfa selectively activates the T cells best suited to fight those tumors. Translational data confirmed T-cell expansion in all eight patients examined, mirroring results seen with invikafusp alfa alone.
By the Numbers
Why it matters: Many breast cancer patients — especially those with TNBC — don't benefit from immunotherapy alone. This combination could open a new door for immune-based treatment in tumors that have historically been resistant to it, with randomized trials now being planned to confirm the added benefit.
