On Oct. 17, 2025, Sensei Biotherapeutics announced that the dose‑expansion portion of its Phase 1/2 trial of solnerstotug, a conditionally active anti‑VISTA antibody, achieved a 6‑month progression‑free survival (PFS) rate of 37% overall and 50% in patients with prior PD‑(L)1 resistance. The data were presented during a mini‑oral session at the ESMO Congress in Berlin.
The trial enrolled 44 “hot” tumor patients who had progressed on PD‑(L)1 therapy and 20 “cold” tumor patients. At the 15 mg/kg dose of solnerstotug combined with cemiplimab, six clinical responses were observed, including five in PD‑(L)1‑resistant patients, while no responses were seen at the 3 mg/kg dose. The 6‑month PFS rate of 50% at 15 mg/kg exceeds the 10‑20% benchmark seen with docetaxel in the same setting.
Solnerstotug was well tolerated at both dose levels, with no dose‑limiting toxicities and a safety profile consistent with earlier reports. The company stated that the dose‑dependent activity and durable disease control support advancement into Phase 2 studies, which are planned to begin in 2026 pending additional capital.
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