Multicenter phase 2 trial of first-line sintilimab plus pegaspargase, gemcitabine, and oxaliplatin for advanced extranodal natural killer/T cell lymphoma

The PD-1 inhibitor sintilimab is effective in relapsed and refractory extranodal natural killer/T cell lymphoma (ENKTL), nasal type. The phase 2 SPIRIT trial, at three centers in China, evaluated sintilimab plus P-GEMOX (pegaspargase, gemcitabine, and oxaliplatin) as first-line treatment for advanced ENKTL. Patients received 6 three-week cycles of sintilimab plus P-GEMOX followed by sintilimab every three weeks for up to two years. Complete response was seen in 85% of patients, and partial response in 15%, for an ORR of 100%. Two-year progression-free survival rate was 64% (95% CI 48-86) and three-year overall survival rate was 76% (52-100). There were no severe adverse events. Three of 34 patients died of causes not considered to be treatment related. The authors conclude that the combination of sintilimab with P-GEMOX is an active and safe first-line regimen for patients with advanced ENKTL.