Sehgal Alison, Hoda Daanish, Riedell Peter A, Ghosh Nilanjan, Hamadani Mehdi, Hildebrandt Gerhard C, Godwin John E, Reagan Patrick M, Wagner-Johnston Nina D, Essell James, Nath Rajneesh, Solomon Scott R, Champion Rebecca, Licitra Edward, Fanning Suzanne, Gupta Neel K, Chow Victor A, Yuan Brenda, Yang Zhi, Ogasawara Ken, Thorpe Jerill, Gordon Leo I
University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA.
Loveland Clinic for Blood Cancer Therapy, Intermountain Healthcare, Salt Lake City, UT.
Blood Adv. 2025 Aug 12;9(15):3694-3705. doi: 10.1182/bloodadvances.2024015262.
We report final analysis results from the PILOT study of lisocabtagene maraleucel (liso-cel) for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Sixty-one adults with R/R LBCL who had received 1 previous line of therapy and met ≥1 hematopoietic stem cell transplantation (HSCT) not intended criterion. Overall response rate (primary end point) was 80%; 54% achieved complete response. After median on-study follow-up of 18.2 months, median duration of response was 23.3 months (95% confidence interval [CI], 6.2 to not reached [NR]). Median progression-free survival (PFS) was 9.0 months (95% CI, 4.2 to NR), median overall survival (OS) was NR (95% CI, 16.3 to NR), and 18-month PFS and OS rates were 43% (95% CI, 30-55) and 59% (95% CI, 45-70), respectively. In the treatment-emergent (TE) period (≤90 days after liso-cel administration), 79% had grade ≥3 adverse events (AEs), 38% had cytokine release syndrome (2% grade 3; no grade 4/5), 31% had neurological events (5% grade 3; no grade 4/5), and 7% had grade ≥3 infections. Of 57 patients in the post-TE period (≥91 days after liso-cel administration), 18% experienced grade ≥3 AEs; 1 patient had grade ≥3 infections. Thirty patients in the leukapheresis set (n = 74) died, mostly of disease progression (n = 24). In this population with high incidence of high-grade B-cell lymphoma, primary-refractory disease, advanced age, and comorbidities, liso-cel demonstrated durable efficacy and a favorable safety profile, consistent with previous reports. These results support liso-cel as second-line therapy for this underserved population of patients with R/R LBCL not intended for HSCT. This trial was registered at www.clinicaltrials.gov as #NCT03483103.
我们报告了利妥昔单抗（liso-cel）用于复发/难治性（R/R）大B细胞淋巴瘤（LBCL）患者的先导研究的最终分析结果。61名患有R/R LBCL的成年人，他们之前接受过1线治疗，且符合≥1项非意向性造血干细胞移植（HSCT）标准。总缓解率（主要终点）为80%；54%达到完全缓解。在中位研究随访18.2个月后，中位缓解持续时间为23.3个月（95%置信区间[CI]，6.2至未达到[NR]）。中位无进展生存期（PFS）为9.0个月（95%CI，4.2至NR），中位总生存期（OS）未达到（95%CI，16.3至NR），18个月的PFS和OS率分别为43%（95%CI，30-55）和59%（95%CI，45-70）。在治疗出现期（利妥昔单抗给药后≤90天），79%的患者发生≥3级不良事件（AE），38%的患者发生细胞因子释放综合征（2%为3级；无4/5级），31%的患者发生神经事件（5%为3级；无4/5级），7%的患者发生≥3级感染。在治疗出现期后（利妥昔单抗给药后≥91天）的57名患者中，18%经历了≥3级AE；1名患者发生≥3级感染。白细胞分离采集组中的30名患者（n = 74）死亡，大多死于疾病进展（n = 24）。在这个高级别B细胞淋巴瘤、原发难治性疾病、高龄和合并症发生率高的人群中，利妥昔单抗显示出持久的疗效和良好的安全性，与之前的报告一致。这些结果支持利妥昔单抗作为不适用于HSCT的R/R LBCL这一未得到充分治疗的患者群体的二线治疗药物。该试验在www.clinicaltrials.gov上注册，编号为#NCT03483103。
