POLARIS-02

NCT02836834 📎

Regimen

Experimental
Toripalimab 3 mg/kg IV every 2 weeks until confirmed progression or unacceptable toxicity
Control
none

Population

Chemorefractory recurrent or metastatic NPC; all patients had failed prior chemotherapy; 92 of 190 had failed at least two prior lines; enrolled at Chinese centers

Key finding

POLARIS-02 was the pivotal single-arm phase 2 study that supported the NMPA approval of toripalimab in chemorefractory RM NPC. With 190 patients — the largest single-arm 2L NPC immunotherapy study — it demonstrated durable responses (median DOR 12.8 months) despite a modest ORR of 20.5%. EBV DNA ≥50% decrease at day 28 was strongly predictive of response (ORR 48.3% vs 5.7%). Toripalimab is the drug — not camrelizumab or tislelizumab.

Source: PMID 33492986

Timeline

    Guideline citations

    • NCCN NPC (p.42)