【2024 ASH年会速递】ADC药物在ALL中的研究前沿

英文标题：Sinusoidal Obstruction Syndrome in Children with CD22+ B-Cell Precursors Acute Lymphoblastic Leukemia (BCP-ALL) Treated with Inotuzumab Ozogamicin in Trial ITCC-059: Risk Factors and Outcomes

中文标题：ITCC-059试验：InO治疗儿童CD22+ B细胞前体ALL（BCP-ALL）患者肝窦阻塞综合征（SOS）：危险因素和结局

汇报作者及医院：Erica Brivio Princess Maxima Center for Pediatric Oncology, Utrecht, Netherlands

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：儿童和年轻成人患者的临床试验

分享时间：2024年12月8日（周日），上午8:45（北京时间，GMT+8）

Objective: One of the most relevant toxicities associated with InO is sinusoidal obstruction syndrome (SOS), especially following hematopoietic stem cell transplantation (HSCT). We report the SOS cases from the pediatric trial ITCC-059 (NCT02981628).

研究目的：报告来自儿科试验ITCC-059（NCT02981628）的SOS病例。

Conclusion: SOS occurred in 13% of pediatric patients treated with InO, and in 20% of subsequent patients after a subsequent transplant. Patients receiving HSCT after InO had 1y-OS of 69.3%, which is encouraging in this population.

研究结论：在接受InO治疗的儿童患者中，SOS发生率是13%，在随后接受移植的患者中为20%。在InO治疗后接受造血干细胞移植（HSCT）的患者中，1年总生存率（OS）为69.3%，令人鼓舞。

英文标题：Dose Optimization of Inotuzumab Ozogamicin in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

中文标题：复发/难治成人ALL患者的InO剂量优化

汇报作者及医院：Daniel J. DeAngelo Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

会议主题：612. 急性淋巴细胞白血病：临床和流行病学：深入研究B-ALL：淋巴细胞白血病的遗传、表型和动态预后预测因素

分享时间：2024年12月10日（周二），上午03:45（北京时间，GMT+8）

Objective: To evaluate the rates of VOD and hematologic remission (CR/CRi) for the two InO dose levels.The goal of the analyses reported here is to support a particular InO dosing regimen.

研究目的：评估两种InO剂量水平的肝小静脉闭塞病（VOD）和血液学缓解（CR/CRi）率。报告分析的目标是支持特定的InO剂量方案。

Conclusion: The CR/CRi rates for patients at doses of 1.2 mg/m2/cycle and 1.8 mg/m2/cycle were 72% (46/64) and 68% (26/38), respectively. Of the patients who achieved CR/CRi, 72% and 69% of patients achieved MRD-negativity at above two doses. These analyses indicate that the current FDA approved higher dose of 1.8 mg/m2/cycle provides a favorable balance of safety and efficacy as compared to the lower dose of 1.2 mg/m2/cycle in adult patients with R/R ALL.

研究结论：在1.2 mg/ m²/周期和1.8 mg/ m²/周期剂量下，患者的CR/CRi率分别为72%（46/64）和68%（26/38）。在达到CR/CRi的患者中，分别有72%和69%的患者MRD阴性。与较低剂量1.2 mg/ m²/周期相比，当前FDA批准的较高剂量1.8 mg/ m²/周期为复发/难治（R/R ）ALL成人患者提供了有利的安全性和有效性平衡。

英文标题：Safety and Efficacy Results of Dose-Adjusted Inotuzumab Ozogamicin in Adults with B Cell Acute Lymphoblastic Leukemia: A Retrospective Single-Center Experience

中文标题：成人B-ALL患者中剂量调整后的InO的安全性和有效性结果：一项回顾性单中心经验

汇报作者及医院：姜尔烈 中国医学科学院血液病医院（中国医学科学院血液学研究所）

会议主题：612. 急性淋巴细胞白血病：临床和流行病学：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Objective: To present a summary of real-world data on the treatment patterns, effectiveness, and safety of InO in Chinese patients with newly diagnosed (ND), MRD-positive, and R/R B-ALL. Given the high cost of InO, the dose was adjusted to 1 mg (approximately 0.6 mg/m²) per administration.

研究目的：展示InO在新诊断、MRD阳性和R/R B-ALL患者中的治疗模式、有效性和安全性的中国真实世界数据。鉴于InO成本较高，剂量调整为每次1mg（约0.6 mg/m²）。

Conclusion: The median dose of InO was 2 (range: 1-3) and the median time to remission was 30 (range: 16-78) days. Eight (61.5%) patients achieved CR/CRi, 5 of whom achieved MRD negative. After that, 7 patients received alloHSCT, and 4 were second HSCT. 1-year OS rate was 36.9±13.8%. No veno-occlusive disease (VOD) occurred during InO treatment or in the post-transplantation period. The results of this study indicate that dose-adjusted InO is a well-tolerated and effective treatment option for B-ALL adults with or without chemotherapy or TKI. It can be employed as a frontline induction, consolidation, maintenance and MRD clearance, and salvage therapy.

研究结论：InO的中位剂量是2（范围：1-3），达到缓解的中位时间是30天（范围：16-78）。8名（61.5%）患者达到了CR/CRi，其中5名患者MRD阴性。之后，7名患者接受了alloHSCT，其中4名是第二次HSCT，1年OS为36.9±13.8%。在InO治疗期间或移植后期没有发生VOD。剂量调整后的InO对于有无化疗或TKI的成人B-ALL患者耐受性良好且有效，可被用作前线诱导、巩固、维持和MRD清除以及挽救治疗。

英文标题：Interim Results of a Phase II Study Investigating Dasatinib and Inotuzumab Ozogamicin-Based Induction for Newly-Diagnosed Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

中文标题：新诊断的费城染色体阳性ALL（Ph+ ALL）采用达沙替尼（DAS）和InO诱导治疗： 一项II 期研究中期结果

汇报作者及医院：Anand Ashwin Patel Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, IL

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Objective: We hypothesized that induction with dasatinib (DAS) + InO for newly-diagnosed (ND) Ph+ ALL would achieve high rates of major molecular response (MMR) or better while minimizing cytotoxic chemotherapy.

研究目的：观察是否对于新诊断的 Ph+ ALL，采用DAS+ InO 诱导治疗可实现高 主要分子缓解（MMR） 或更好的治疗效果，同时尽量减少细胞毒性化疗。

Conclusion: DAS + InO induction has an MMR+CMR (complete molecular response) rate of 83% within 2 courses thus far; 100% of pts achieved CMR and/or MRD negativity by NGS within 3 courses. No cases of VOD were seen after decoupling DAS and InO in Schema 2. There have been no relapses thus far.

研究结论：截至目前，在 2 个疗程内，DAS + InO 诱导治疗 主要分子缓解+完全分子缓解（MMR+CMR）率为 83%；在 3 个疗程内，100% NGS 检测示CMR 和/或 MRD 阴性。在方案 2 中，单独使用DAS 和InO，未出现VOD病例。尚无复发病例。

英文标题：Updated Results from a Phase II Study Hyper-CVAD, with or without Inotuzumab Ozogamicin, and Sequential Blinatumomab in Patients with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia

中文标题：一项II期研究的更新结果：对于新诊断的B-ALL患者，使用含/不含InO的Hyper-CVAD方案以及序贯贝林妥欧单抗治疗

汇报作者及医院：Daniel Nguyen University of Texas MD Anderson Cancer Center, Houston, TX

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Objective: InO improves OS in the relapsed/refractory setting, and we hypothesized that the addition of InO to hyper-CVAD plus blinatumomab would lead to deeper and more durable responses, reduce relapses, and improve survival. We present 30-month follow-up data since amendment of the protocol to include InO.

研究目的：InO可改善复发/难治患者的OS，假设在 Hyper-CVAD 加贝林妥欧单抗的方案中加入InO 会带来更深入、更持久缓解，减少复发并提高生存率。研究展示加入InO 30 个月的随访数据。

Conclusion: The 30-month RFS in the cohorts with and without INO were 91% vs 74% (P=0.05), and the OS was 100% vs 82% (p=0.008). Among HR pts, the 30-month RFS in the cohort with and without INO were 92% vs 67% (P=0.07) and the OS was 100% vs 76% (P=0.05). In pts with newly diagnosed Ph-negative B-ALL, the addition of InO to the hyper-CVAD + blinatumomab appears to improve OS.

研究结论：使用和未使用InO的队列中，30个月无复发生存（RFS）率分别为91%和74%（P=0.05），OS率分别为100%和82%（p=0.008）。在高危（HR）患者中，使用和未使用InO的队列中，30个月RFS率分别为92%和67%（P=0.07），OS分别为100%和76%（P=0.05）。在新诊断的Ph- B-ALL患者中，在 Hyper-CVAD +贝林妥欧单抗的方案中加入 INO可改善患者OS。

英文标题：Low Intensity Mini-Hypercvd (mHCVD), Inotuzumab Ozogamicin (Ino) with/without Blinatumomab (Blina) in Older Patients with Newly Diagnosed Philadelphia Negative B-Cell Acute Lymphoblastic Leukemia (B-ALL): 10 Years Update

中文标题：低强度Mini-Hypercvd（mHCVD）、InO联合或不联合贝林妥欧单抗（Blina）在新诊断Ph- B-ALL老年患者中的应用：10年数据更新

汇报作者及医院：Jayastu Senapati Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Objective: To report the long-term safety and efficacy of InO with/without Blina added to mHCVD regimen as frontline therapy in older adults (60 ≥ yrs) with Philadelphia (Ph) negative B-ALL with 10-year follow-up.

研究目的：报告InO联合或不联合Blina作为前线治疗，添加到mHCVD方案中，用于治疗60岁以上Ph- B-ALL老年患者的长期安全性和有效性，随访期为10年。

Conclusion: At a med estimated F/U of 121 mos (95% CI 61-129 mos), (129 mos pre-amendment and 46 mos post-amendment pts), the med PFS was 47 mos (95%CI 22-71 mos), OS 62 mos (95%CI 22-72 mos) and continuous remission duration (CRD) not reached (95% CI NR-NR). mHCVD-InO  Blina is an efficacious and tolerable regimen with promising PFS and OS benefit even on long-term F/U.

研究结论：在中位估计随访时间121个月（95% CI 61-129个月，修正前129个月，修正后46个月）时，中位无进展生存期（PFS）为47个月（95% CI 22-71个月），OS为62个月（95% CI 22-72个月）。mHCVD-InO-Blina方案是一种有效且耐受性好的治疗方案，即使在长期随访中，也展示出优异的PFS和OS。

英文标题：Chemotherapy Free Regimen of Inotuzumab Ozogamicin and Blinatumomab in Frontline Therapy of Older Patients with Philadelphia Negative B-Cell Acute Lymphoblastic Leukemia

中文标题：InO和Blina无化疗方案在Ph- B-ALL老年患者前线治疗中的应用

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

汇报作者及医院：Jayastu Senapati MBBS Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

Objective: To report a chemotherapy minimized InO/Blina based treatment approach for frontline therapy in older pts with Ph-ve B-cell ALL.

研究目的：报告一种针对Ph- B-ALL老年患者前线治疗的最小化化疗联合InO/Blina治疗方案。

Conclusion: A chemotherapy minimized combination of InO and Blina leads to promising response and survival outcomes in older pts with newly diagnosed B-ALL and appears tolerable.

研究结论：在新诊断的B-ALL老年患者中，最小化化疗联合InO/Blina的治疗方案展示出卓有成效的缓解和生存结局，且可耐受。

英文标题：Outcomes of Adult Patients with Philadelphia Negative B-Cell Acute Lymphoblastic Leukemia (B-ALL) Having Myeloid Type Mutations Treated with Inotuzumab/Blinatumomab Containing Frontline Regimens

中文标题：携带髓样型突变（MyM）的成人Ph- B-ALL患者，接受含InO/Blina前线治疗方案的治疗结局

汇报作者及医院：Jayastu Senapati Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

会议主题：614. 急性淋巴细胞性白血病：诊断和预后中的生物标志物、分子标志物和微小残留病变：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Background：Targeted therapies like InO and Blina are often being used in frontline therapy for B-ALL and prognostic impact of MyM with such agents need further evaluation.

研究背景：InO和Blina靶向疗法通常用于B-ALL的前线治疗 ，需进一步评估其对MyM的预后影响。

Conclusion: Baseline MyM in pts with B-cell ALL are rare and more common in older pts. Though PFS and OS were inferior in MyM+ pts in the whole cohort, age stratified analysis and MVA diminished their independent impact on survival in pts treated with InO/Blina based frontline therapy.

研究结论：B-ALL患者中基线MyM较罕见，且多见于老年患者。尽管在整个队列中，MyM+患者PFS和OS较差，但年龄分层分析和多变量分析（MVA）减少了其对接受InO/Blina前线治疗患者生存的独立影响。

英文标题：Addition of Inotuzumab Ozogamicin to Melphalan Plus Fludarabine Reduced-Intensity Conditioning Regimen of Allogeneic Transplantation in Patients with Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies: A Phase II Prospective Trial

中文标题：在美法仑+氟达拉滨的低强度预处理方案中加入InO，用于ALL和侵袭性淋巴瘤患者的异基因移植：一项II期前瞻性研究

汇报作者及医院：Issa F. Khouri Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, T

会议主题：异基因移植：预处理方案、植入和急性毒性反应：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Background: Patients with ALL and aggressive lymphoma require more intense conditioning than bendamustine, fludarabine, and rituximab should HCT be required. The safety of InO in these circumstances is unknown.

研究背景：需要进行HCT的ALL和侵袭性淋巴瘤患者需要使用比苯达莫司汀、氟达拉滨和利妥昔单抗更强烈的预处理。在这些情况下InO的安全性尚不清楚。

Conclusion: Our data suggest that InO is safe when combined with a melphalan plus fludarabine HCT conditioning regimen. The survival outcomes are encouraging and need to be validated in a larger number of patients.

研究结论：InO与美法仑+氟达拉滨的HCT预处理方案联合使用是安全的。生存结局令人鼓舞，需要在更多的患者中进行验证。

英文标题：Still You Hesitate to Use Ino?: Inotuzumab Ozogamicin Optimized Post-Transplant Outcomes in R/R Ph-Negative B-ALL

中文标题：仍在犹豫是否使用InO？：InO优化R/R Ph- B-ALL移植后结局

汇报作者及医院：Ryo Koizumi Department of Hematology, Toranomon Hospital, Minato-Ku, TKY, Japan

会议主题：732. 异基因移植：疾病反应和比较治疗研究：海报专场一

分享时间：2024年12月8日（周日），上午9:30-11:30（北京时间，GMT+8）

Objective: To compare transplant outcomes after InO treatment to those after conventional standard chemotherapy.

研究目的：比较 InO 治疗与常规标准化疗后的移植结局。

Conclusion: Results showed that the InO group was significantly higher 2-year OS compared to the SC group (51.7% vs. 24.7%, p=0.04). Our results encourage the salvage chemotherapy with InO before allogeneic HCT especially in Ph-negative R/R B-ALL patients. Compared to SC, InO had a higher remission induction rate, better post-transplant prognosis, and controllable post-transplant SOS.

研究结论：与标准化疗（SC）组相比，InO组的2年OS显著更高（51.7% 对比 24.7%，p=0.04）。鼓励在HCT前使用 InO 进行挽救治疗，特别是在Ph- R/R B-ALL患者中。与标准化疗相比，InO 具有更高的诱导缓解率、更好的移植后预后以及可控的移植后SOS。

英文标题：Updated Results of the Combination of Mini-Hyper-CVD with Inotuzumab Ozogamicin and Blinatumomab in Patients with Relapsed/Refractory B-Cell ALL

中文标题：在R/R B-ALL患者中，mHCVD联合InO和Blina的最新研究结果

汇报作者及医院：Fadi G. Haddad, MD Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

会议主题:  613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场二

分享时间：2024年12月9日（周一），上午10:00-12:00（北京时间，GMT+8）

Objective: To report updated results from a phase II trial including the dose-dense (D-D) administration of InO and Blina in combination with chemotherapy with longer follow-up.

研究目的：报告一项 II 期试验的最新结果，采用特定时间间隔给予InO和 Blina联合化疗，并进行更长时间随访。

Conclusion: The combination of mini-HCVD, InO and Blina is safe and effective in R/R B-ALL. Introducing Blina and fractionating InO seem to improve the safety and efficacy of this combination. Using a D-D approach resulted in high rates of deep and early MRD responses and promising survival outcomes, which may be better than the sequential use of these agents.

研究结论：mHCVD、InO和 Blina 联合治疗在 R/R B - ALL 中安全有效。应用Blina 并在特定时间间隔给予InO可提高这种联合治疗的安全性和有效性。使用D-D给药方法实现高比例患者MRD深度和早期缓解，并带来令人鼓舞的生存结局，可能比药物序贯使用效果更好。

英文标题：Treatment Outcomes of Adult Patients with B-Cell Acute Lymphoblastic Leukemia Relapsed after Allogeneic Stem Cell Transplant in the Era of Novel Immunochemotherapeutic Agents

中文标题：新型免疫治疗药物时代，异基因干细胞移植后复发成人 B-ALL患者的治疗结局

汇报作者及医院：Hiroaki Shimizu Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan

会议主题：723. 异基因移植：长期随访、并发症及疾病复发：海报专场二

分享时间：2024年12月9日（周一），上午10:00-12:00（北京时间，GMT+8）

Objective: Although novel immunochemotherapeutic agents, InO and Blina improved treatment outcomes of relapse/refractory B-ALL patients, efficacy and safety of these agents in those with post-transplant relapse remain to be fully elucidated.

研究目的：尽管新型免疫治疗药物InO和Blina改善了R/R B-ALL患者的治疗结局，但在移植后复发患者中的有效性和安全性尚未完全阐明。

Conclusion: The prognosis of adult Ph-negative B-ALL patients relapsed after the first SCT improved in the era of novel immunochemotherapeutic agents. Although safety profiles of InO and Blina treatments appeared acceptable, it is important to ensure an enough duration between InO administration and a second SCT to reduce VOD.

研究结论：在新型免疫治疗药物时代，成人Ph- B-ALL患者在首次SCT后复发的预后有所改善。尽管InO和Blina治疗的安全性可接受，但要确保InO给药和第二次SCT之间有足够的时间间隔，以减少VOD发生。

英文标题：Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in the Open-Label, Multi-Center, Global, Single-Arm, Phase Ib/II FELIX Study: The Impact of Bridging Therapies on CAR T-Cell Expansion and Persistence

中文标题：新一代CAR-T疗法Obecabtagene autoleucel（obe-cel）用于成人R/R B-ALL：开放标签、多中心、全球、单臂 Ib/II 期 FELIX 研究：桥接治疗对CAR-T细胞扩增和持久性的影响

汇报作者及医院：Jae H. Park Memorial Sloan Kettering Cancer Center, New York, NY

会议主题：704. 细胞免疫疗法：早期临床试验及毒性：海报专场二

分享时间：2024年12月9日（周一），上午10:00-12:00（北京时间，GMT+8）

Objective: To report the impact of Bridging therapies (BT) with and without inotuzumab ozogamicin (InO) on tumor burden at lymphodepletion (LD) and pharmacokinetics (PK), including CAR-T expansion and persistence.

研究目的：报告桥接治疗(BT) 是否应用InO对于淋巴清除（LD）的肿瘤负荷及药代动力学（PK）的影响，包括 CAR-T 细胞的扩增和持久性。

Conclusion: BT with InO is effective in reducing disease burden prior to obe-cel infusion. No apparent differences in expansion and long-term persistence of obe-cel were observed based on any of the BT evaluated, suggesting that long-term persistence of obe-cel is possible irrespective of BT and independent of initial tumor burden at LD. Reduction in tumor burden at LD through BT with InO led to more favorable survival outcomes compared with BT without InO, while maintaining a tolerable safety profile.

研究结论：在 obe-cel 输注前，InO 进行的 BT 可有效减轻疾病负荷。根据所评估的任何 BT，未观察到 obe-cel 的扩增和长期持久性有明显差异，这表明 obe-cel 的长期持久性可能不受 BT 影响，且与 LD 时的初始肿瘤负荷无关。与不含 InO 的 BT 相比，通过含 InO的 BT 在 LD 时减轻肿瘤负荷可带来更有利的生存结果，同时保持可耐受的安全性。

英文标题：Phase II Study of Inotuzumab Ozogamicin for the Treatment of Measurable Residual Disease-Positive B-Cell Acute Lymphoblastic Leukemia: 3-Year Update

中文标题：InO治疗可测量残留病灶（MRD）阳性 B-ALL的 II 期研究：3 年数据更新

汇报作者及医院：Fadi G. Haddad Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场三

分享时间：2024年12月10日（周二），上午10:00-12:00（北京时间，GMT+8）

Objective: To evaluate the efficacy and safety of INO given at reduced dosing in patients with B-cell ALL in hematologic complete remission with positive MRD status 1x10⁴.

研究目的：评估降低剂量的InO在血液学完全缓解、MRD 1x10⁴阳性 B-ALL 患者中的疗效和安全性。

Conclusion: InO resulted in high survival and MRD negativity rates in most patients with B-cell ALL and persistent MRD or MRD recurrence, with a favorable safety profile.

研究结论：大多数持续 MRD 或 MRD 复发的B-ALL患者使用InO具有较高的生存率和 MRD 阴性率，且安全性良好。

英文标题：Inotuzumab Ozogamicin Administration in First Remission Results in Profound and Safe Minimal Residual Disease Eradication in Adult Patients with Ph-Negative Acute Lymphoblastic Leukemia: Findings from a Phase 2, Single-Arm Trial

中文标题：在首次完全缓解（CR1）成人Ph- ALL患者中使用InO，可实现深度且安全的MRD清除：一项 2 期单臂试验结果

汇报作者及医院：顾闰夏 中国医学科学院血液病医院（中国医学科学院血液学研究所）

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场三

分享时间：2024年12月10日（周二），上午10:00-12:00（北京时间，GMT+8）

Objective: To investigate the effectiveness of early administration of InO in achieving minimal residual disease (MRD) clearance in first remission and to assess the change in MRD levels from baseline to InO administration.

研究目的：探讨CR1后早期给予InO实现MRD清除的有效性，并评估从基线到给予 InO 时 MRD 水平的变化。

Conclusion: The early administration of InO in CR1, even with a single course, can effectively eradicate MRD to a deep level. Moreover, early use of InO exhibits a favorable safety profile and did not significantly increase the risk of post-transplant VOD occurrence, making it a safe and effective treatment option for patients with B-ALL.

研究结论：在 CR1 后早期给予 InO，即使是单疗程，也可有效实现MRD深度清除。此外，早期使用 InO 具有良好的安全性，并且不会显著增加移植后VOD的发生风险，使其成为B-ALL患者安全有效的治疗选择。

英文标题：A Retrospective Study of Inotuzumab Ozogamicin in Individuals with Down Syndrome and B-Cell Acute Lymphoblastic Leukemia

中文标题：一项InO在唐氏综合征（DS）合并 B-ALL患者中的回顾性研究

汇报作者及医院：Amanda M Li BC Children Hospital, University of British Columbia, Vancouver, BC, Canada

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场三

分享时间：2024年12月10日（周二），上午10:00-12:00（北京时间，GMT+8）

Objective: To report a retrospective study of children, adolescents and young adults (AYA) with DS and B-ALL treated with InO, to provide real-world safety and efficacy data in this vulnerable population.

研究目的：报告一项接受InO治疗的DS和B-ALL儿童、青少年和年轻成人（AYA）的回顾性研究，以提供这类易感人群的真实世界InO安全性和有效性数据。

Conclusions: InO demonstrated efficacy and a tolerability profile that may be acceptable compared to intensive salvage chemotherapy in children and AYA with DS and relapsed ALL, with 10 of 23 (43.5%) maintaining subsequent durable remissions.

研究结论：InO显示出的有效性和耐受性或与儿童和AYA DS及复发ALL患者接受的强化挽救化疗相当，23人中有10人（43.5%）实现了持续的长期缓解。

英文标题：Extended Follow-up of Dose-Adjusted EPOCH (DA-EPOCH) Plus Inotuzumab Ozogamicin (InO) in Adults with Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL): A Safe and Effective Salvage Therapy

中文标题：剂量调整的 EPOCH（DA-EPOCH）联合InO用于成人R/R B-ALL的延长随访：一种安全且有效的挽救疗法

会议主题：613. 急性淋巴细胞白血病：非异基因移植治疗：海报专场三

分享时间：2024年12月10日（周二），上午10:00-12:00（北京时间，GMT+8）

汇报作者及医院：Noam E. Kopmar University of Washington, Seattle, WA Fred Hutchinson Cancer Center, Seattle, WA

Objective: To describe extended follow-up of all patients (pts) treated with DA-EPOCH-InO for R/R B-ALL at our center, including as a standard option off-protocol (SOC).

研究目的：描述在我们中心接受 DA-EPOCH-InO 治疗的所有R/R B-ALL患者的长期随访情况，包括作为方案之外标准选择（SOC）患者的随访情况。

Conclusion: With extended follow-up and additional pts, DA-EPOCH-InO has consistently demonstrated response rates among the highest ever reported in pts with R/R B-ALL. Additionally, this combination has a favorable safety profile (rare significant hepatotoxicity and only 1 case of SOS) and facilitated consolidation with HCT or CD19-directed imtx in most responders. It also allows administration of InO in an outpatient setting, an important practical consideration. Overall, these data support both the current use and further development (e.g., as frontline therapy) of this regimen for pts with B-ALL.

研究结论：随着随访时间延长和更多患者加入，DA-EPOCH-InO方案在R/R B-ALL患者中始终表现出极高的缓解率，同时具有良好的安全性（严重肝毒性罕见，仅有 1 例SOS），并有助于大多数患者缓解后进行HCT或 CD19导向的免疫治疗作为巩固治疗。研究还支持在门诊中使用 InO，这是一个重要的实际考虑因素。总的来说，研究支持该联合方案在B-ALL患者中的当前应用及进一步发展（例如作为前线治疗）。

【结语】

InO作为一种创新的ADC药物，在治疗B-ALL方面具有显著的疗效和良好的安全性。通过与传统化疗药物、免疫治疗及其他靶向药物联合使用，InO不仅提高了B-ALL的治疗缓解率，也为患者提供了更多的治疗选择。此次ASH大会的入选研究展现了InO令人期待的疗效和安全性，为其在不同临床场景下的应用提供了坚实的科学依据，值得进一步研究与深入探索，期待未来B-ALL患者能够迎来更有效的治疗策略和更好的临床结局。