替雷利珠单抗治疗复发/难治性成熟 T 细胞与 NK 细胞肿瘤：一项多中心开放标签 II 期研究

Patients with relapsed/refractory (R/R) mature T- and natural killer (NK)-cell neoplasms lack effective treatments after failure of standard therapies. This phase 2 study evaluated the efficacy and safety of the programmed cell death protein 1 inhibitor tislelizumab in these patients. Seventy-seven patients were treated with 200 mg tislelizumab every 3 weeks. Twenty-two patients with extranodal NK-/T-cell lymphomas were enrolled in cohort 1; 44 patients with peripheral T-cell lymphoma (PTCL) were enrolled in cohort 2 (21 patients had PTCL not otherwise specified, 11 patients had angioimmunoblastic T-cell lymphoma, and 12 patients had anaplastic large-cell lymphoma). Cohort 3 comprised 11 patients with cutaneous T-cell lymphoma, of which 8 patients had mycosis fungoides (MF) and 3 had S zary syndrome.

Of the 77 patients, 76. 6% had advanced-stage disease, 51. 9% had refractory disease, and 49. 4% received 3 prior systemic regimens. Promising efficacy was observed in cohort 3 (median follow-up [FU], 16. 6 months; overall response rate [ORR], 45. 5%; complete response [CR], 9. 1%; median duration of response [DOR], 11. 3 months; median progression-free survival, 16.

8 months; median overall survival, not reached). Modest efficacy was observed in cohort 1 (median FU, 8. 4 months; ORR, 31. 8%; CR, 18. 2%; median DOR, not reached) and cohort 2 (median FU, 9. 3 months; ORR, 20. 5%; CR, 9. 1%; median DOR, 8. 2 months). Most treatment-related adverse events were grade 1 or 2, and the safety profile was consistent with the known safety profile of tislelizumab.

In conclusion, tislelizumab was well tolerated, achieving modest efficacy in R/R mature T- and NK-cell neoplasms, with some long-lasting remissions. This trial was registered at www. clinicaltrials. gov as #NCT03493451.