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To date, no checkpoint inhibitors have been approved for the treatment of nasopharyngeal cancer (NPC).
Toripalimab is a new type of programmed death protein-1 (PD-1) inhibitor used to treat relapse or metastatic nasopharyngeal cancer (RM-NPC) that is not effective for standard chemotherapy.
POLARISM-02 study was designed to assess Toripalimab's anti-tumor activity, safety and biomarkers.
This is a one-arm, multi-center Phase II study in which patients with RM-NPC receive Toripalimab treatment (3 mg/kg, static drops, 1 time/2 weeks) until the disease progresses or becomes unacceptablely toxic.
main endpoint is the Objective Response Rate (ORR).
secondary endpoints include security, mitigation duration (DOR), progress-free lifetime (PFS), and total lifetime (OS).
prognostic (PFS and OS) of patients with different PD-L1 states recruited a total of 190 patients, with an ORR of 20.5%, a medium DOR of 12.8 months, a medium PFS of 1.9 months and a medium OS of 17.4 months.
ORR was 23.9 percent of the 92 patients who failed only two lines of chemotherapy.
ORR in patients with PD-L1 positive (-) and PD-L1-negative (-) was 27.1% and 19.4%, respectively. on the 28th day of
, the number of copies of EB virus DNA decreased by ≥50% in patients with ANR value of 48.3%, significantly better than the decrease in the number of copies of plasma EB virus DNA in patients (5.7%, p -0.0001).
median tumor mutation load (TMB) in the prognostic (PFS and OS) queues of patients with different TMB states was 0.95 mut/megablyblyb, which had no predictive value for treatment response.
of 174 patients showed that patients with chromosome 11q13 region amplification or ETV6 genetic variation had a poorer response to toripalimab.
, polarIS-02 studies have shown that toripalimab has controlled safety and long-lasting clinical efficacy in patients with chemotherapy-resistant metastatic nasopharyngeal cancer.
of DNA copies of early plasma EB virus was associated with a good treatment response.
