Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Trial
The POLARIS-02 study demonstrated a manageable safety profile and durable clinical response of toripalimab in patients with chemorefractory metastatic NPC.
This Phase‑II study evaluated toripalimab, a PD‑1 inhibitor, as second‑line or later therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (RM‑NPC) refractory to standard chemotherapy. Among 190 patients, the objective response rate (ORR) was 20.5% (95% CI 15.0‑27.0), disease‑control rate (DCR) 40.0% (95% CI 33.0‑47.3), median progression‑free survival (PFS) 1.9 months, and median overall survival (OS) 17.4 months. Early reduction in plasma Epstein‑Barr virus DNA copy number correlated with response. Genomic amplification in the 11q13 region or ETV6 alterations were associated with poorer response.
Bizonyítékszint: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.
Kapcsolódó jelek
- Anti‑PD‑1 antibody penpulimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: a randomized, double‑blind phase 3 study
- Advances in targeted therapy mainly based on signal pathways for nasopharyngeal carcinoma
- Nasopharyngeal Cancer
- Hierarchical dynamic model for risk‑stratified screening of nasopharyngeal carcinoma
- Expert consensus on the role of immunotherapy in nasopharyngeal carcinoma: clinical and economic perspectives from the GCC region