| Sumario: | Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are ineligible for cisplatin have limited treatment options, and the role of chemoimmunotherapy in this population remains unexplored. NIVOTAX was a randomized, non-comparative, multicenter, phase II trial evaluating paclitaxel plus nivolumab (nivotax) in previously untreated, platinum-ineligible R/M HNSCC (platinum-refractory, unfit, or cumulative dose ≥225 mg/m²). Patients were randomized 2:1 to weekly paclitaxel (80 mg/m²) plus biweekly nivolumab (240 mg) or weekly cetuximab (250 mg/m²) for 12 weeks, followed by maintenance nivolumab q4 weeks or weekly cetuximab for up to 24 months. The primary endpoint was 2-year overall survival (2yOS). Key secondary endpoints were median OS; progression-free survival (PFS), overall response rate (ORR) and safety. 141 patients were randomized (nivotax, n = 93; Erbitax, n = 48). Baseline characteristics were balanced. After a median follow-up of 12.1 months (33.1 months for alive patients), 2yOS was 24.7% (95% CI 15.9–33.5) with nivotax and 13.4% (95% CI 3.6–23.2) with Erbitax. Median OS, PFS and ORR were similar in both arms. No differences were observed by age, PD-L1 CPS and Karnofsky Performance Scale. Grade > 3 treatment-related adverse events (AEs) occurred in 38% and 43% of patients, respectively. Higher mortality was observed in the nivotax arm (18% vs 8.3%) due to higher occurrence of respiratory AEs deemed treatment unrelated by investigators. The primary endpoint of 2yOS was met. However, respiratory AEs and associated mortality emerged as a safety concern in the nivotax arm, limiting further evaluation of this regimen. • The NIVOTAX trial met its primary endpoint of improved 2-year OS rate. • PFS, ORR and DCR were similar in nivotax and erbitax regimens. • Age, KPI and PDL1 CPS status did not impact on efficacy parameters. • Safety profile was similar in both treatment regimens. • Increased treatment unrelated respiratory events led to higher mortality in the nivotax arm.
|
|---|