401 | PHASE II STUDY OF CONCURRENT TISLELIZIMAB AND RADIOTHERAPY FOR TREATMENT‐NAÏVE, NEWLY DIAGNOSED LOW‐RISK EXTRANODAL NK/T‐CELL LYMPHOMA, NASAL TYPE

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Introduction: Stage IV Natural killer/T-cell lymphoma (NKTCL) has a poor prognosis.Asparaginase is the backbone drug for the treatment of NKTCL.Anti-PD-1 antibody is effective for relapsed/refractory NKTCL.Our previous study found that angiogenesis inhibitor anlotinib was active in relapsed/refractory NKTCL.This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib (LEAP regimen) in the treatment of stage IV NKTCL patients unfit for high-dose induction chemotherapy.Methods: Eligible patients met the following criteria: (1) Histologically confirmed NKTCL with stage IV classification per Lugano 2014 criteria; (2) Age > 65 years or ≤ 65 years with protocol-defined contraindications to high-dose methotrexate/ dexamethasone.The LEAP regimen comprised 3-week cycles (maximum 8 cycles): Sintilimab 200 mg IV day 1; Pegaspargase 2500 IU/m 2 IM day 1; Anlotinib 8 mg PO days 1-14.Complete responders could receive consolidative autologous hematopoietic stem cell transplantation (auto-HSCT) at investigator discretion.The primary endpoint was complete response (CR) rate at 24 weeks by Lugano 2014 criteria.Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety analysis using CTCAE v4.0.Results: Thirty-seven patients were enrolled (median age 64 years; range 32-78; M:F = 22:15) from July 2019 to April 2021.The median treatment duration was 8 cycles (range 2-8), with 72.9% (27/37) achieving CR and an objective response rate of 83.8% (31/37).Disease progression occurred in 16.2% (6/37) during treatment.Following induction therapy, 63.0% (17/27) of CR patients underwent consolidative auto-HSCT versus 37.0% (10/27) who entered observation.With a median follow-up of 48 months (95% CI: 45.2-50.8), the auto-HSCT cohort demonstrated significantly lower relapse rates (17.6% vs. 60.0%,p < 0.05).Survival outcomes revealed 1-/4-year PFS rates of 78.4% (95% CI: 61.4%-88.6%)/56.6%(39.2%-70.7%)and 1-/4-year OS rates of 83.8% (67.4%-92.4%)/75.2%(57.7%-86.3%).All patients experienced treatment-related adverse events (AEs), predominantly grade 1-2 asparaginase-associated toxicities).Grade ≥ 3 AEs included neutropenia (10.8%) and hyperbilirubinemia (10.8%).No AE-related treatment discontinuations occurred.Conclusions: The LEAP regimen demonstrates robust clinical efficacy (CR rate 72.9%) and favorable tolerability in high-risk stage IV NKTCL patients ineligible for intensive induction chemotherapy.However, the high post-remission relapse rate (60%) in non-consolidated patients underscores the necessity for effective maintenance strategies.Our findings suggest consolidative auto-HSCT significantly improves disease free survival, potentially bridging the gap between immunotherapy and durable remission in this challenging patient population.

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