CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：IMMPACT-MM: Insights into Multiple Myeloma Patient Outcomes following Early-Line Cilta-cel Treatment.
IMMPACT-MM: Insights into Multiple Myeloma Patient Outcomes following Early-Line Cilta-cel Treatment.
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这项真实世界研究证明 cilta-cel 在既往 1-3 线治疗后的 RRMM 中的有效性。
西达基奥仑赛（cilta-cel）已在复发/难治性多发性骨髓瘤（RRMM）患者中显示深度且持久的应答，支持以持续微小残留病（MRD）阴性作为潜在功能性治愈的标志，即长期无治疗的疾病控制。最初，cilta-cel在美国获批用于既往接受4线治疗后的RRMM，并于2024年4月扩展至既往接受1–3线治疗的患者。本研究描述既往接受1–3线治疗后使用cilta-cel的真实世界临床结局，包括MRD阴性情况。
使用Loopback Analytics电子病历（2024年4月至2025年5月），并补充医师记录。纳入既往接受1–3线治疗后接受cilta-cel的RRMM成人患者。评估输注后结局（cilta-cel应答、MRD阴性、疾病进展和总生存期），并按桥接治疗（BT）方案进行总体及分层分析。
共纳入120例患者（中位年龄67岁，女性43.3%）。输注前87.5%接受BT，包括烷化剂方案（28.6%）、免疫调节剂/单克隆抗体方案（25.7%）、蛋白酶体抑制剂方案（20.0%）、talquetamab（14.3%）及其他方案（11.4%）。中位随访5.8个月，在完成疗效评估的患者中（81.7%），cilta-cel总体缓解率（ORR）为98.0%，其中72.4%达到完全缓解。在36例可评估MRD的患者中，35例（97.2%）达到MRD阴性（10^-5），达到MRD阴性的中位时间为80.0天。末次随访时，94.2%的患者仍无进展，95.8%尚未开始后续治疗，99.2%仍存活。不同BT方案的cilta-cel ORR为95%–100%，MRD阴性率为80%–100%。
这项真实世界研究显示，cilta-cel对既往接受1–3线治疗的RRMM有效。总体及不同BT方案（包括talquetamab）患者中均报告了较高的缓解率和MRD阴性率。更长时间的随访及重复MRD测量有助于进一步了解应答持久性和生存结局，并评估实现功能性治愈的可能性。
Electronic medical records from Loopback Analytics (April 2024-May 2025) were used, supplemented with physician notes. Adults with RRMM treated with cilta-cel after 1-3 prior LOT were included. Post-infusion outcomes (cilta-cel response, MRD negativity, disease progression, and overall survival) were assessed overall and by bridging therapy (BT) regimen.
Overall, 120 patients were included (median age 67 years, 43.3% female). Prior to infusion, 87.5% received BT, including alkylator-based (28.6%), IMiD mAb-based (25.7%), PI-based (20.0%), talquetamab (14.3%), and other regimens (11.4%). Over a median follow-up of 5.8 months, among patients with a response assessment (81.7%), the overall response rate (ORR) to cilta-cel was 98.0%, including 72.4% with complete response. Among 36 MRD-evaluable patients, MRD negativity (10 -5 ) was achieved in 35 (97.2%), with a median time to MRD negativity of 80.0 days. At last follow-up, 94.2% of patients remained progression-free, 95.8% had not initiated subsequent treatment, and 99.2% remained alive. Across BT regimens, ORR to cilta-cel was 95-100% and MRD negativity was achieved in 80-100%.
This real-world study demonstrates the effectiveness of cilta-cel in RRMM after 1-3 prior LOT. High rates of response and MRD negativity were reported overall and across BT regimens, including talquetamab. Longer follow-up with repeated MRD measurements may provide further insights into response durability and survival outcomes, helping to contextualize the potential for a functional cure.
在 PubMed 查看 → 出版商原文（DOI） 全文 PDF（PMC）· 可下载 治疗专题与资料阅读指南 资料来源与翻译说明 报告译文或资料问题 →
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