Phase 2 trial of anti-PD-1 plus nab-paclitaxel and bevacizumab as second-line treatment for cancer of unknown primary

The phase 2 Fudan CUP-002 trial, at Fudan University Shanghai Cancer Center (Shanghai, China) evaluated the efficacy and safety of an anti-PD-1 antibody in combination with nab-paclitaxel and bevacizumab as second-line treatment of cancer of unknown primary (CUP). A total of 48 eligible patients were enrolled. The median follow-up was 27.1 months. The objective response rate was 54.2% (95% CI 40.3-67.4) and the disease control rate was 95.8% (86.0-98.9); the median progression-free survival was 13.1 months (8.0-19.6) and the median overall survival was 25.1 months (14.6-29.5). Treatment-related adverse events of any grade occurred in 95.8%. Exploratory analysis identified systemic eosinophil counts as prognostic biomarker for response and survival outcomes in second-line setting for CUP. The authors conclude that the combination of an anti-PD-1 antibody with nab-paclitaxel and bevacizumab was effective and well-tolerated as second-line treatment for patients with CUP.