Retrospective study of activity of low-dose nivolumab in patients with advanced squamous cell carcinomas and other cancers

Immune checkpoint inhibitors (ICIs) such as anti-PD-1 antibodies are essential in cancer therapy. Emerging data suggest that lower than conventional doses may be effective A retrospective study at Centre Léon Bérard (Lyon, France) assessed the efficacy and safety of low-dose nivolumab (20 mg every 3 weeks) in patients with advanced cancer, mainly squamous cell carcinomas (SCC). In 2023 and 2024, 53 patients were treated, with a median age of 74 years; 39.6% were aged over 80 years. Most were male (64% and had an ECOG performance status ≥ 2 (69.9%). Primary tumor sites included cutaneous SCC (34%), head and neck SCC (32%), and soft tissue sarcoma (15%). The median follow-up was 8.3 months. The median overall survival was 7.5 months. The median objective response rate (ORR) was 20.8%, driven by the SCC subgroup; no responses were observed in non-SCC histologies, in patients with prior ICI exposure, or beyond the second line of treatment. Among IO-naïve SCC patients treated in first or second line (n=22), ORR was 50%. Toxicity was manageable: 18.7% experienced immune-related adverse events, with only 3.7% grade 3. The authors conclude that low-dose nivolumab demonstrated encouraging efficacy and tolerability in a frail population of SCC patients, supporting its potential role in resource-limited settings (graphical abstract).