Overview
- At the November 30, 2025 cutoff, the combination produced 1 confirmed complete response and 3 partial responses among the 10 patients at the three highest dose levels, with a 60% disease control rate and a median 15 months on treatment among responders.
- Clinical responses occurred at the 1,000 mg and 2,000 mg PLN-101095 doses in cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non–small cell lung cancer.
- PLN-101095 was given as monotherapy for 14 days before adding pembrolizumab, with responses concentrated at higher dose cohorts in this open-label phase 1 dose-escalation study (total n=16).
- Safety findings included rash in 50%, anemia in 19%, and diarrhea in 19% of patients, with serious treatment-emergent adverse events reported in 31%.
- Responders showed 4- to 13-fold increases in plasma interferon gamma after the monotherapy run-in, and Pliant plans a Phase 1b indication expansion in 2026 with final data to be presented at a scientific meeting.