不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial.
Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial.
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EPCORE NHL-1关键研究在复发/难治性(R/R)大B细胞淋巴瘤(LBCL)中单药使用CD3×CD20双特异性抗体epcoritamab,主要结果(中位随访10.7个月)显示应答深且持久。本文报告LBCL患者的长期疗效和安全性结果(N=157;中位随访25.1个月)。截至2023年4月21日,客观缓解率为63.1%,完全缓解(CR)率为40.1%。估算的24个月无进展生存期(PFS)和总生存期(OS)率分别为27.8%和44.6%。估算24个月时仍处于CR的比例为64.2%。完全缓解者估算的24个月PFS和OS率分别为65.1%和78.2%。119例可评估微小残留病(MRD)的患者中,45.4%达到MRD阴性,且与更长PFS和OS相关。各预设亚组CR率总体一致:既往接受CAR-T 治疗者36%、原发难治性疾病患者32%、国际预后指数评分3分患者37%。最常见治疗期间不良事件为细胞因子释放综合征(51.0%)、发热(24.8%)、疲劳(24.2%)和中性粒细胞减少(23.6%)。结果突显epcoritamab治疗R/R LBCL的长期获益,其在各亚组均可产生深度缓解,包括难治且预期预后不良的患者。临床试验注册:ClinicalTrials.gov NCT03625037。
Primary results (median follow-up, 10. 7 months) from the pivotal EPCORE NHL-1 study in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) demonstrated deep, durable responses with epcoritamab, a CD3xCD20 bispecific antibody, when used as monotherapy.
We report long-term efficacy and safety results in patients with LBCL (N = 157; 25. 1-month median follow-up). As of April 21, 2023, overall response rate was 63. 1% and complete response (CR) rate was 40. 1%. Estimated 24-month progression-free survival (PFS) and overall survival (OS) rates were 27. 8% and 44. 6%, respectively. An estimated 64. 2% of complete responders remained in CR at 24 months. Estimated 24-month PFS and OS rates among complete responders were 65. 1% and 78. 2%, respectively. Of 119 minimal residual disease (MRD)-evaluable patients, 45. 4% had MRD negativity, which correlated with longer PFS and OS.
CR rates were generally consistent across predefined subgroups: 36% prior chimeric antigen receptor (CAR) T-cell therapy, 32% primary refractory disease, and 37% International Prognostic Index 3. The most common treatment-emergent adverse events were cytokine release syndrome (51. 0%), pyrexia (24.
8%), fatigue (24. 2%), and neutropenia (23. 6%). These results underscore the long-term benefit of epcoritamab for treating R/R LBCL with deep responses across subgroups, including patients with hard-to-treat disease and expected poor prognosis (ClinicalTrials. gov Registration: NCT03625037).
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