Note: Recruitment for this phase 1 and 2 trial was also open to patients with metastatic castration-resistant prostate cancer (mCRPC), but the exact number of mCRPC patients enrolled is currently unknown.

Invikafusp alfa (STAR0602), has shown early promise in a recent clinical trial called STARt-001. This trial focused on patients with advanced solid tumors who had not responded to anti-PD-1 therapy, a common challenge in cancer treatment.

Invikafusp alfa works by selectively activating specific subsets of T cells, the immune system’s powerful weapon against cancer. This unique mechanism of action, targeting TCRVβ6/Vβ10 T cells, has demonstrated encouraging results:.

• Disease Control Rate (DCR): 50% of the 28 patients enrolled in the Phase 1 dose escalation cohorts achieved disease control. This includes both patients who experienced partial response (tumor shrinkage) and those with stable disease.
• Tumor Shrinkage: 32% of patients in the Phase 1 dose escalation cohorts experienced a reduction in tumor size.
• TMB-H Subgroup DCR: 63% of patients with high tumor mutation burden (TMB-H) cancers achieved disease control at the optimal biological dose range.
• TMB-H Subgroup Tumor Shrinkage: 50% of patients with TMB-H cancers experienced tumor shrinkage at the optimal dose.
• TMB-H Subgroup Objective Response Rate (ORR): 25% This means that 25% of patients in this subgroup experienced a significant and confirmed tumor shrinkage.
• Vβ6/Vβ10 T Cell Expansion: Up to ~500% peak increase was observed in patients following treatment with invikafusp alfa. This indicates that the treatment effectively stimulated the expansion of these specific T cell subsets.

These findings, though preliminary, suggest that invikafusp alfa could be a valuable new tool in the fight against advanced cancers. The ability to activate the immune system in a targeted and controlled manner, even in patients who have failed other therapies, represents a significant advancement in cancer treatment.

While the Phase 2 portion of the STARt-001 trial is ongoing, with results expected in 2025, the initial data is a beacon of hope for patients and researchers alike. Invikafusp alfa’s unique mechanism of action and early clinical success pave the way for a potential new era of personalized cancer immunotherapy.