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替雷利珠单抗治疗复发/难治性多发性骨髓瘤(RRMM)的真实世界评估:一项国际骨髓瘤工作组研究

Real-world evaluation of teclistamab for the treatment of relapsed/refractory multiple myeloma (RRMM): an International Myeloma Working Group Study.

作者信息

Tan Carlyn Rose, Asoori Sireesha, Huang Chiung-Yu, Brunaldi Larissa, Popat Rakesh, Kastritis Efstathios, Martinez-Lopez Joaquin, Bansal Radhika, Silva Corraes Andre De Menezes, Chhabra Saurabh, Parrondo Ricardo, Ailawadhi Sikander, Fotiou Despina, Dimopoulos Meletios A, Yong Kwee, Mactier Catriona, Lau Chris, Corona Magdalena, Marin Adolfo Jesús Sáez, Mian Hira, Durie Brian Gm, Usmani Saad Z, Martin Thomas G, Lin Yi

机构信息

Memorial Sloan Kettering Cancer Center, New York, NY, USA.

University of California, San Francisco, CA, USA.

出版信息

Blood Cancer J. 2025 Apr 3;15(1):53. doi: 10.1038/s41408-025-01259-z.

DOI:10.1038/s41408-025-01259-z
PMID:40175336
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11965530/
Abstract

Teclistamab, a BCMAxCD3-directed bispecific antibody, has shown high response rates and durable remissions in triple-class-exposed patients with relapsed/refractory multiple myeloma. We performed a retrospective study evaluating the efficacy and safety of teclistamab in 210 patients treated at 9 academic centers from five countries within the IMWG Immunotherapy Working Group Committee. Patients were heavily pretreated, with 83% having triple-class refractory disease and 44% with prior BCMA-targeted therapy. With a median follow-up of 5.3 months, the overall response rate (ORR) was 67% in 188 response-evaluable patients, including 55% with a very good partial response or better. The 6-month progression-free survival (PFS) and overall survival rates were 53% (95% CI, 46-61%) and 73% (67-80%), respectively. Patients who received prior BCMA-directed therapy compared to BCMA-treatment-naïve patients had a lower ORR (58.3 vs 74.0%; P = 0.03) and PFS (6-month PFS 43% [95% CI, 33-55%] vs 63% [54-73%]; logrank P = 0.004). Step-up dosing occurred in an outpatient setting for 23% of patients. CRS occurred in 54% of patients, and infections were reported in 56.2% of patients, with 22% having grade ≥3 infections. In this multicenter real-world study, we found that teclistamab can lead to rapid responses in heavily pretreated myeloma patients with comparable efficacy and safety profiles, as demonstrated in MajesTEC-1.

摘要

泰吉华单抗(Teclistamab)是一种靶向B细胞成熟抗原(BCMA)和CD3的双特异性抗体,在接受过三类药物治疗的复发/难治性多发性骨髓瘤患者中显示出高缓解率和持久缓解。我们进行了一项回顾性研究,评估泰吉华单抗在国际骨髓瘤工作组免疫治疗工作组成员的9个学术中心治疗的210例患者中的疗效和安全性。患者接受了大量前期治疗,83%患有三类药物难治性疾病,44%接受过先前的BCMA靶向治疗。中位随访5.3个月,188例可评估缓解的患者的总缓解率(ORR)为67%,其中55%为非常好的部分缓解或更好。6个月无进展生存期(PFS)和总生存率分别为53%(95%CI,46-61%)和73%(67-80%)。与未接受过BCMA治疗的患者相比,接受过先前BCMA靶向治疗的患者的ORR较低(58.3%对74.0%;P=0.03),PFS也较低(6个月PFS为43%[95%CI,33-55%]对63%[54-73%];对数秩检验P=0.004)。23%的患者在门诊进行了逐步给药。54%的患者发生了细胞因子释放综合征(CRS),56.2%的患者报告有感染,22%的患者发生≥3级感染。在这项多中心真实世界研究中,我们发现泰吉华单抗可使接受过大量前期治疗的骨髓瘤患者快速缓解,疗效和安全性与MajesTEC-1试验中所证相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/5634b9152016/41408_2025_1259_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/64cf8844ff5d/41408_2025_1259_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/5eeb8608989a/41408_2025_1259_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/1bad615717e4/41408_2025_1259_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/5634b9152016/41408_2025_1259_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/64cf8844ff5d/41408_2025_1259_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/5eeb8608989a/41408_2025_1259_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/1bad615717e4/41408_2025_1259_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efca/11965530/5634b9152016/41408_2025_1259_Fig4_HTML.jpg

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