IOMAB-ACT: a Phase Ib/II Multi-institutional Study of 131 I-Apamistamab Followed by CD19-targeted CAR-T Cell Therapy for Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion in patients with Relapsed or refractory (R/R) Diffuse large B-cell lymphoma (DLBCL).

开始日期2025-04-01

申办/合作机构

The University of Texas Southwestern Medical Center

[+1]

NCT04512716

/ Recruiting早期临床1期IIT

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.

开始日期2021-02-02

申办/合作机构

Memorial Sloan Kettering Cancer Center

NCT02665065

/ Active, not recruiting临床3期

A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML)

The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).

开始日期2016-06-01

申办/合作机构

Actinium Pharmaceuticals, Inc.

100 项与 I-131-Apamistamab 相关的临床结果

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100 项与 I-131-Apamistamab 相关的转化医学

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100 项与 I-131-Apamistamab 相关的专利（医药）

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项与 I-131-Apamistamab 相关的文献（医药）

2025-01-10·JOURNAL OF CLINICAL ONCOLOGY

Randomized Phase III SIERRA Trial of ¹³¹ I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML

Article

作者: Schuster, Michael ; Pandit-Taskar, Neeta ; Abboud, Camille ; Foran, James ; Larkin, Karilyn ; Reddy, Vijay ; Lazarus, Hillard M. ; Koshy, Nebu ; Jamieson, Katarzyna ; Choe, Hannah ; Haeuber, Elaina ; Law, Arjun Datt ; Gyurkocza, Boglarka ; Rowley, Scott D. ; Litzow, Mark R. ; Tomlinson, Benjamin ; Seropian, Stuart ; Silverman, Margarida ; Orozco, Johnnie J. ; McNamara, Kathleen ; Sandmaier, Brenda M. ; MacDougall, James ; Desai, Avinash ; Pagel, John M. ; Spross, Jennifer ; Levy, Moshe Y. ; Munshi, Pashna ; Sabloff, Mitchell ; Hari, Parameswaran ; Cook, Rachel ; Van Besien, Koen ; Stiff, Patrick ; Kebriaei, Partow ; Giralt, Sergio ; Abhyankar, Sunil ; Vusirikala, Madhuri ; Nahar, Akash ; Chen, George ; Al-Kadhimi, Zaid ; Nath, Rajneesh

PURPOSE:

Older patients with relapsed or refractory AML (RR AML) have dismal prognoses without allogeneic hematopoietic cell transplantation (alloHCT). SIERRA compared a targeted pretransplant regimen involving the anti-CD45 radioconjugate 131 I-apamistamab with conventional care.

METHODS:

SIERRA (ClinicalTrials.gov identifier: NCT02665065 ) was a phase III open-label trial. Patients age ≥55 years with active RR AML were randomly assigned 1:1 to either an 131 I-apamistamab–led regimen before alloHCT or conventional care followed by alloHCT if initial complete remission (CR)/CR with incomplete platelet recovery (CRp) occurred. Initial response was assessed 28-56 days after alloHCT in the 131 I-apamistamab group and 28-42 days after salvage chemotherapy initiation; patients without CR/CRp or with AML progression could cross over to receive 131 I-apamistamab followed by alloHCT. The primary end point was durable complete remission (dCR) lasting 180 days after initial CR/CRp. Secondary end points were overall survival (OS) and event-free survival (EFS), assessed hierarchically in the intention-to-treat (ITT) population.

RESULTS:

The ITT population included 153 patients ( 131 I-apamistamab [n = 76]; conventional care [n = 77]). In total, 44/77 conventional care arm patients crossed over and 40/77 (52%) received 131 I-apamistamab and alloHCT, with six patients (13.6%) experiencing a dCR. In the ITT population, the dCR rate was significantly higher with 131 I-apamistamab (17.1% [95% CI, 9.4 to 27.5]) than conventional care (0% [95% CI, 0 to 4.7]; P < .0001). The OS hazard ratio (HR) was 0.99 (95% CI, 0.70 to 1.41; P = .96), and the EFS HR was 0.23 (95% CI, 0.15 to 0.34), with HR <1 favoring 131 I-apamistamab. Grade ≥3 treatment-related adverse events occurred in 59.7% and 59.2% of the 131 I-apamistamab and conventional care groups, respectively.

CONCLUSION:

The 131 I-apamistamab–led regimen was associated with a higher dCR rate than conventional care in older patients with RR AML. 131 I-apamistamab was well tolerated and could address an unmet need in this population.

2009-06-04·Blood1区 · 医学

131I anti-CD45 radioimmunotherapy effectively targets and treats T-cell non-Hodgkin lymphoma

1区 · 医学

Article

作者: Press, Oliver W. ; Fromm, Jonathan R. ; Gopal, Ajay K. ; Pagel, John M. ; Wilbur, Shani

Abstract:

Radioimmunotherapy (RIT) options for T-cell non-Hodgkin lymphomas (T-NHLs) are limited. We evaluated anti-CD45-RIT in human (h) and murine (m) T-NHL. CD45 was highly expressed on hT-NHL patient samples (median, 2.3 × 105 antigen-binding capacity units/cell) and hT-NHL cell lines (3.4 × 105 CD45 antigen-binding capacity units/cell). Biodistribution studies in hTNHL xenografts showed that 131I-labeled BC8 (anti-hCD45) delivered 154% (P = .01) and 237% (P = .002) more radioiodine to tumor sites over control antibodies at 24 hours and 48 hours, respectively. Importantly, tumor sites targeted with 131I-BC8 exhibited 2.5-fold (P = .05), 3.0-fold (P = .007), and 3.6-fold (P = .07) higher 131I retention over the nontarget organs of lungs, liver, and kidneys, respectively (24 hours). Because the clinical use of anti-hCD45 would target both T-NHL and other hematolymphoid tissues, we evaluated the ability of anti-mCD45 to target mT-NHL. mT-NHL grafts targeted with anti-mCD45 correspondingly retained 5.3 (P < .001), 5.4 (P < .001), and 8.7 (P < .001) times the radioactivity in tumor sites compared with nontarget organs of lung, liver, and kidney. 131I-labeled BC8 therapy yielded improved complete remission rates (75% vs 0%, P < .001) and progression-free survivals (median, 23 days vs 4.5 days, P < .001) compared with controls. These data indicate that the high CD45 expression of T-NHL allows reliable tumor targeting and disease control supporting anti-CD45 RIT for T-NHL patients.

2006-10-01·Indian journal of experimental biology

Heat stress induced apoptosis in BC-8 cells derived from AK-5 tumor involves downregulation of Bcl-2 and generation of reactive oxygen species.

Article

作者: Pardhasaradhi, B V V ; Kumari, A Leela ; Rangaraj, Nandini ; Khar, Ashok ; Varalakshmi, Ch

BC-8, a rat histiocytoma undergoes apoptosis after heat shock, which is due to lack of an effective heat shock response. Heat shock induced generation of free radicals, which in turn are involved in the induction of apoptotic death in BC-8 cells. Treatment of BC-8 cells with N-acetylcysteine partially inhibited the heat induced apoptosis. Introduction of Bcl-2 gene in these cells did not protect them from apoptotic death, whereas transfection with hsp-70 gene did render these cells resistant to heat induced apoptosis transiently. Heat shock also downregulated the expression of Bcl-2 and p53 in these cells. These observations suggested that the heat shock induced apoptosis was mediated through reactive oxygen species and controlled upstream of Bcl-2 check point.

项与 I-131-Apamistamab 相关的新闻（医药）

2025-02-18

·小核说核药

Lintuzumab-Ac225联合CLAG-M治疗AML的1期研究进展

01. 背景简介 2024年8月，Actinium Pharmaceuticals开发的用于治疗急性髓系白血病（AML）的Iomab-B（131I-apamistamab）尽管在3期临床试验中显示出统计学上显著的主要终点效果，但其生物制品许可申请（BLA）被FDA拒绝，需要额外的头对头随机临床试验来证明其总体生存期获益，目前Actinium公司正在为Iomab-B寻找战略合作伙伴，也算是暂时搁置了Iomab-B这款产品并将重点转移到Actimab-A管线的开发上... JNM：血液肿瘤中的诊疗核药现状综述！ 2025年2月，美国威斯康星医学院的Sameem M. Abedin为通讯作者在国际著名血液学杂志Leukemia（IF=12.883）在线发表题为“Phase 1 study of lintuzumab-Ac225 combined with CLAG-M salvage therapy in relapsed/refractory acute myeloid leukemia”的1期临床研究评估了Lintuzumab-Ac225联合CLAG-M挽救治疗方案在复发/难治性AML患者中的安全性和有效性。 CLAG-M（克拉屈滨、高剂量阿糖胞苷、米托蒽醌和粒细胞集落刺激因子（G-CSF）是一种有效的挽救性化疗方案，但单用化疗的疗效仍不理想。Lintuzumab是一种抗 CD33 单克隆抗体，与放射性同位素 Ac225 结合，形成的Lintuzumab-Ac225有望增强对 AML 细胞的杀伤能力。这项单中心、开放标签的1期临床试验，采用3+3剂量递增设计，旨在确定Lintuzumab-Ac225的最大耐受剂量（MTD）和推荐的2期剂量（RP2D）。研究共纳入26名患者，其中21名接受剂量递增治疗，5名接受RP2D扩展队列治疗。 ★治疗方案：患者在完成CLAG-M（克拉屈滨、阿糖胞苷、G-CSF和米托蒽醌）挽救治疗后7天内接受Lintuzumab-Ac225单次输注，剂量范围为0.25-1.0 µCi/kg。 ★主要终点：确定MTD、RP2D以及安全性。 ★次要终点：包括完全缓解率（CR）、微小残留病（MRD）阴性率、1年和2年生存率等。 02. 研究结果 1.最大耐受剂量（MTD）：研究确定MTD和RP2D为0.75 µCi/kg。 2.安全性：所有患者均经历了至少一次治疗相关不良事件（TEAE），主要为血液学毒性，如发热性中性粒细胞减少症（65.4%）和白细胞减少（50%）。未观察到剂量限制性毒性（DLT），表明该联合方案具有良好的耐受性。 3.疗效：复合完全缓解率（CRc）：这是指完全缓解（CR）和完全缓解伴不完全血液学恢复（CRi）的总和。在23名可评估的患者中，CRc率为56.5%，而在推荐2期剂量（RP2D）0.75 µCi/kg Lintuzumab-Ac225下，CRc率提高到了62.5%。总体缓解率（ORR）：这是指所有缓解情况（包括CR、CRi和形态学白血病无病状态MLFS）的总和。所有患者的ORR为65.2%，在RP2D下，ORR提高到了75%。特定患者群体的疗效：在14名之前接受过1或2种治疗方案的患者中，CRc率为79%；在20名高危AML患者中，CRc率为50%，ORR为60%。微小残留病（MRD）阴性率：在12名可评估的应答者中，8名达到MRD阴性（66.7%）。生存率：2年总生存率（OS）为23.1%，1年无进展生存率（PFS）为30.8%。 4.药代动力学：Lintuzumab-Ac225在体内的清除速度较快，半衰期为8.25小时。图1展示了在推荐2期剂量（RP2D）0.75 µCi/kg Lintuzumab-Ac225下，5名患者接受单次0.5小时静脉输注后的总放射性活度随时间变化的个体浓度-时间曲线。表2列出了不同剂量组患者经历的3级和4级不良事件的类型和发生率。表3提供了在RP2D下Lintuzumab-Ac225的药代动力学参数，包括AUC、Cmax、tmax、t1/2等。表4展示了23名可评估患者的治疗反应。 03. 小结这项研究首次将放射免疫治疗药物Lintuzumab-Ac225与高强度化疗方案CLAG-M联合应用于AML患者，结果显示该联合方案不仅安全、耐受性良好，还能显著提高患者的缓解率和生存率。特别是对于高危患者（如TP53突变或既往接受过维奈克拉治疗的患者），该方案仍能保持较高的缓解率和生存率。此外，研究还发现，Lintuzumab-Ac225联合治疗方案在清除微小残留病方面表现出色，这一特点对于改善患者的长期预后具有重要意义。这项1期研究的结果为复发/难治性AML的治疗提供了新的思路和希望。未来，研究团队计划开展更大规模的临床试验，进一步验证该联合方案的疗效和安全性。文末附上了原文链接，方便读者检索拜读。 ●Nectin-4靶向新核药：68Ga-FZ-NR-1的临床首秀！ ●东诚核药177Lu-LNC1004 II期临床研究结果揭晓！ ●新核药助力乳腺癌精准诊疗——CDK4/6成像新突破！ ●2025开年巨献：核药发展现状全景解析！声明：本文观点仅代表小核本人，视角局限，欢迎批评指正；如需转载，请务必注明文章作者和来源。如有其它问题，请在本平台留言或联系xiaoheshuoheyao777@163.com，小核将在第一时间处理。内容编辑 | AI+小核排版设计 | 小核媒体合作 | 科研宣传 | 转载开白 xiaoheshuoheyao777（小核微信）

临床2期临床结果临床1期临床3期

2024-11-18

·PRNewswire

Actinium Pharmaceuticals Highlights Antibody Radiation Conjugate Program Developments and Reports Financial Results for the Third Quarter 2024

- Aligned with FDA on operationally seamless Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory acute myeloid leukemia - Actimab-A selected for National Cancer Institute's recently opened myeloMATCH precision medicines program for patients with acute myeloid leukemia and myelodysplastic syndromes - Two Iomab-ACT INDs cleared by FDA: Commercial CAR-T trial at University of Texas Southwestern and sickle cell transplant trial at Columbia University; proof-of-concept safety and efficacy data expected in 2025 - Actinium seeking U.S. strategic partner for Iomab-B to conduct dose optimization and head-to-head Phase 3 trial based on FDA guidance in adult patients with active relapsed or refractory acute myeloid leukemia - Accomplished biopharma industry executive June Almenoff, M.D., Ph.D., appointed to Actinium's Board of Directors - Cash and cash equivalents of approximately $78.6 million as of September 30, 2024, is expected to fund operations into 2027 NEW YORK, Nov. 18, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today highlighted recent regulatory and development updates for its Iomab-B, Actimab-A and Iomab-ACT ARC clinical programs as well as its financial results for the third quarter ended September 30, 2024. Iomab-B is a first in class CD45 targeted conditioning agent to enable bone marrow transplant (BMT) and has been studied in over four hundred patients including the completed Phase 3 SIERRA trial for patients with relapsed or refractory acute myeloid leukemia (r/r AML). Actimab-A is a targeted radiotherapeutic that uses the Actinium-225 (Ac-225) isotope payload directed against CD33 with broad potential for development in AML and other myeloid indications including in collaboration with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA). Iomab-ACT is a next-generation CD45 targeted conditioning agent being developed for cell and gene therapies for both malignant and non-malignant hematologic indications. Actinium is executing cutting-edge R&D focused on ARCs and other targeted radiotherapies for blood cancer and solid tumor indications leveraging its strong intellectual property portfolio of 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. Sandesh Seth, Actinium's Chairman and CEO, stated, "During the third quarter and over the last several weeks, we have made significant progress with our three ARC clinical programs. Actinium is now positioned to advance exciting clinical trials for Actimab-A and Iomab-ACT in large indications with high unmet needs that can deliver impactful clinical data in 2025. Actimab-A's backbone therapy potential is poised to be realized with the operationally seamless Phase 2/3 trial following alignment with the FDA, additional clinical trials being planned under the NCI CRADA including the myeloMATCH program and via our R&D efforts to further elucidate Actimab-A's mutation agnostic mechanism of action. The clinical data anticipated from Iomab-ACT in 2025 from the commercial CAR-T and sickle cell transplant trials has the potential to establish Iomab-ACT as a best-in-class targeted conditioning agent for both malignant and non-malignant hematology indications. In addition, our recent meeting with the FDA regarding Iomab-B established a clear development pathway, which will be incredibly valuable in securing a U.S. strategic partner. Finally, I am delighted to welcome Dr. June Almenoff to our Board of Directors, who brings over 25 years of biopharma industry experience with a proven track record of leading drug development through approvals and executing value enhancing business development transactions." Actimab-A Regulatory and Development Update Actinium met with the FDA in the third quarter and aligned with the FDA on an operationally seamless randomized Phase 2/3 trial to study Actimab-A + CLAG-M In the Phase 2 portion of the study, the Actimab-A dose will be optimized in combination with CLAG-M The Phase 3 portion will study the optimized dose of Actimab-A + CLAG-M versus CLAG-M alone in patients with r/r AML Operationally seamless trial design is expected to reduce the required time and resources compared to separate Phase 2 and Phase 3 trials Actinium continues to evaluate and develop additional Actimab-A clinical trials under its CRADA with the NCI, investigator initiated, or Actinium sponsored studies Actimab-A selected by NCI for recently opened myeloMATCH precision medicine program for patients with AML and myelodysplastic syndrome (MDS) Iomab-ACT Program Update In the third quarter, the FDA cleared the investigational new drug (IND) applications for both the commercial CAR-T study led by the University of Texas Southwestern (UTSW) and the sickle cell trial being led by Columbia University The UTSW commercial CAR-T trial expected to initiate patient enrollment in 1Q 2025 with proof-of-concept clinical data expected by year end Commercial CAR-T sales exceeded $3.5 billion in 2023 with multiple CAR-T therapies approved for patients with lymphomas, leukemias and multiple myeloma Columbia University sickle cell transplant trial to study Iomab-ACT for targeted conditioning prior to BMT for the first time in a non-malignant hematology setting, which is a rapidly growing indication for BMT; patient enrollment expected to commence in the first half of 2025 Iomab-B Regulatory Status and Program Update Actinium is seeking a U.S. strategic partner to advance clinical development of Iomab-B including the Phase 3 trial Actinium met with the FDA in the fourth quarter and aligned on the patient population for the head-to-head Phase 3 trial to evaluate allogeneic BMT using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation (Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI Head-to-head Phase 3 trial to enroll adult patients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%, representing a broader patient population than that in the SIERRA trial Dose optimization trial to be completed prior to initiating the head-to-head Phase 3 trial to determine the dose for Iomab-B based on radiation to the bone marrow rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based on several interactions with the FDA before starting the SIERRA trial Mr. Seth added, "We are excited by our recent progress and committed to delivering on several milestones in the near-term and throughout 2025. Our current balance sheet provides strong runway into 2027, which enables us to deliver important clinical data and further realize our vision of being a leading fully integrated specialty radiopharmaceutical company." Third Quarter 2024 Financial Results Cash and cash equivalents of approximately $78.6 million as of September 30, 2024. Based on Actinium's current operating plan, cash and cash equivalents are expected to fund operations into 2027. Research and Development Expense, net of reimbursements Research and development expenses of $9.8 million for the three months ended September 30, 2024 decreased $1.8 million from $11.6 million for the three months ended September 30, 2023. The decrease is primarily a result of a decline in Chemistry, manufacturing and controls, or CMC, expenses of $5.5 million and lower consulting expenses of $0.5 million, both due to lower activity in 2024 related to Iomab-B. These declines were partially offset by increased preclinical expenses of $3.9 million. General and administrative expense General and administrative expenses of $2.8 million for the three months ended September 30, 2024 increased by $0.1 million from $2.7 million for the three months ended September 30, 2023, primarily due to higher non-cash stock compensation expense of $0.5 million, partially offset by lower compensation expense of $0.3 million due to lower headcount. In the third quarter of 2024, our overall headcount reduced by approximately twenty percent, with a majority of these former employees being from our clinical and CMC groups. As a result of these departures, we expect our personnel expenses to be reduced by approximately $3.7 million in 2025, which may be offset by additional hires or consultants. We do not expect these departures to have a material impact on our operations or ability to execute our operating plan and we are actively seeking a strategic partner for Iomab-B in the U.S. to advance the clinical development activity for Iomab-B including the planned Phase 3 trial. Other income Other income is comprised of net interest income in both reporting periods. The amount for the three months ended September 30, 2024 and 2023 of $1.0 million in each reporting period was virtually unchanged from the same time period in the prior year. Net loss Net loss of $11.6 million for the three months ended September 30, 2024 decreased by $1.7 million from $13.3 million for the three months ended September 30, 2023 due to lower research and development expenses partially offset by higher general and administrative expenses. About Actinium Pharmaceuticals, Inc. Actinium develops Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies intended to meaningfully improve outcomes for people who have failed existing oncology therapies. The company continues to advance its development for product candidate Actimab-A, a therapeutic agent that has demonstrated potential activity in r/r AML patients. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with relapsed and refractory acute myeloid leukemia (r/r AML), which Actinium is seeking a potential strategic partner for in the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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临床3期财报临床2期放射疗法

2024-10-25

·immedica.com

Data from the phase 3 SIERRA trial of Iomab-B presented at the annual European Association of Nuclear Medicine (EANM) Congress 2024

Stockholm, October 25, 2024 – Immedica is pleased to announce that data from the Phase 3 SIERRA trial of Iomab-B was presented in both an oral and a poster presentation at the 2024 European Association of Nuclear Medicine (EANM) Congress, held in Hamburg from October 19-23. Immedica is collaborating with Actinium Pharmaceuticals on the development of Iomab-B. Dr. Neeta Pandit-Taskar, Molecular Imaging and Therapy, Memorial Sloan Kettering Cancer Center, New York, U.S. presented the results: Details of the EANM oral presentation: Title (OP-097): “Modeling-based Assessment of Exposure Measurements After High-Dose Targeted 131I-apamistamab: Results and Analyses from the Phase III SIERRA Trial” Session: Cutting Edge Science Track - Featured Session: Radiation Protection Committee / EARL: Radiation Protection for Radionuclide Therapy and Animal Protection Date and Time: October 20, 2024, 09:45 – 11:15 (CET), Hall Y4-Y9 Details of the EANM e-poster presentation: Title (EPS-134): Bone Marrow Dosimetry Exploratory Analysis from the Phase 3 SIERRA Trial of 131I-apamistamab Prior to HCT in Relapsed/Refractory Acute Myeloid Leukemia Session: e-Poster Presentations Session 7: Dosimetry Committee: Evolving Dosimetry Strategies Date and time: October 21, 2024, 15:00 – 16:30 (CET), Hall F. About EANM meeting The EANM Annual Meeting is the premier event for professionals in the field of nuclear medicine, bringing together experts from around the world to discuss the latest advancements, research, and innovations. The meeting provides a platform for sharing knowledge, fostering collaboration, and exploring new developments in diagnostic imaging, radionuclide therapies, and molecular medicine. About Actinium Pharmaceuticals, Inc. Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidate Iomab-B is an induction and conditioning agent prior to bone marrow transplant. Actinium holds more than 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: https://www.actiniumpharma.com/ About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within genetic & metabolic diseases, hematology & oncology and specialty care. Immedica was founded in 2018 and employs today more than 140 people across Europe, the Middle East and the U.S. The main owners are the investment firms KKR and Impilo. For more information visit www.immedica.com Immedica contact: Linda Holmström Head of Communication linda.holmstrom@immedica.com + 46 708 73 40 95 We believe we have an important role to fill in society – bringing new, innovative treatments to patients with rare diseases. Focus areas are within genetic & metabolic diseases, hematology & oncology and specialty care. We operate products from phase 2 and all the way to mature products. ESG is an integrated part of our business model. Stay up to date with our latest news. Telephone: +46 (0) 8 533 39 500 E-mail: info@immedica.com

临床3期临床结果放射疗法

100 项与 I-131-Apamistamab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
难治性急性髓细胞白血病	临床3期	美国	Actinium Pharmaceuticals, Inc.	2016-06-01
难治性急性髓细胞白血病	临床3期	加拿大	Actinium Pharmaceuticals, Inc.	2016-06-01
复发性急性髓细胞白血病	临床3期	美国	Actinium Pharmaceuticals, Inc.	2016-06-01
复发性急性髓细胞白血病	临床3期	加拿大	Actinium Pharmaceuticals, Inc.	2016-06-01
弥漫性大B细胞淋巴瘤	临床2期	美国	Actinium Pharmaceuticals, Inc.	2025-04-01
弥漫性大B细胞淋巴瘤	临床2期	美国	The University of Texas Southwestern Medical Center	2025-04-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2024	N/A	-	-	Iomab-B	製繭膚膚簾廠夢鹽獵積(餘鑰艱範醖憲積鑰憲網) = 觸蓋膚餘鹹襯醖窪積壓繭顧窪蓋鑰選糧築顧餘 (鬱廠壓壓淵鬱淵獵構鬱 )	-	2024-06-09
NCT02665065 (SIERRA, EHA2024) 人工标引	临床3期	急性髓性白血病 TP53 Mutation	153	Iomab-B with fludarabine and total body irradiation	鏇繭獵艱醖壓鬱網鬱齋(廠糧製廠憲顧窪衊壓壓) = 積觸簾鹹齋廠糧鏇鏇繭憲鬱網襯鏇鏇淵範廠襯 (糧鏇遞鬱遞網醖窪襯齋 ) 更多	积极	2024-05-14
				131I-APAMISTAMAB-LED (Conventional Care)	鏇繭獵艱醖壓鬱網鬱齋(廠糧製廠憲顧窪衊壓壓) = 壓淵襯糧積積願獵醖憲憲鬱網襯鏇鏇淵範廠襯 (糧鏇遞鬱遞網醖窪襯齋 ) 更多
NCT02665065 (SIERRA, EHA2024) 人工标引	临床3期	急性髓性白血病 CD45	153	Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT	窪齋繭膚積顧糧艱範網(襯餘鹹壓獵膚積夢壓窪) = 觸餘顧鏇窪觸鹹願鹹獵衊選夢憲蓋鹽網製鹹蓋 (構築憲鑰範願製蓋淵製 ) 更多	积极	2024-05-14
				131I-APAMISTAMAB-LED (Physician’s choice of conventional care (CC))	窪齋繭膚積顧糧艱範網(襯餘鹹壓獵膚積夢壓窪) = 網鏇衊糧遞壓築廠顧範衊選夢憲蓋鹽網製鹹蓋 (構築憲鑰範願製蓋淵製 ) 更多
NCT02665065 (SIERRA, EBMT2024) 人工标引	临床3期	急性髓性白血病 TP53 Mutation	153	Iomab-B	鬱選願夢簾壓壓鏇夢壓(憲構窪艱觸衊簾窪觸網) = 衊獵夢糧膚糧繭襯積艱繭糧鹹鑰遞蓋衊鬱壓鬱 (窪鹽鏇窪築築壓淵繭廠 )	积极	2024-04-17
NCT02665065 (SIERRA, Biospace) 人工标引	临床3期	急性髓性白血病 TP53 Mutation	54	Iomab-B	鏇顧餘窪範襯蓋夢淵簾(繭鏇網窪選糧顧鏇範艱) = 鬱顧膚壓襯範選積膚遞窪餘衊鏇繭壓膚醖壓壓 (遞構選積廠顧憲簾觸餘 ) 更多	积极	2024-02-26
				Crossover	鏇顧餘窪範襯蓋夢淵簾(繭鏇網窪選糧顧鏇範艱) = 醖鏇築鬱網膚選鑰構鬱窪餘衊鏇繭壓膚醖壓壓 (遞構選積廠顧憲簾觸餘 ) 更多
NCT02665065 (SIERRA, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床3期	急性髓性白血病 TP53 Mutation	153	Iomab-B with fludarabine and total body irradiation	簾醖築廠製鏇壓觸齋衊(範壓鹹鬱壓淵廠觸遞鹽) = 觸築觸餘襯繭夢鹹簾鬱築襯襯夢構廠淵壓淵範 (夢醖繭糧選繭醖襯鬱鹽 ) 更多	积极	2024-02-01
				Apamistamab (Conventional Care)	簾醖築廠製鏇壓觸齋衊(範壓鹹鬱壓淵廠觸遞鹽) = 夢網鬱鹽蓋繭齋觸壓遞築襯襯夢構廠淵壓淵範 (夢醖繭糧選繭醖襯鬱鹽 ) 更多
NCT02665065 (SIERRA, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床3期	急性髓性白血病 CD45	153	Iomab-B with fludarabine and total body irradiation (2 Gy)	糧簾鹹窪壓蓋鏇夢鹹餘(淵鹽製餘窪餘範製獵鑰) = 製廠糧觸鏇糧艱憲築顧構築鑰範選獵鹹艱築壓 (觸廠繭網積壓鹹遞遞願, 9.7 ~ 33.1) 更多	积极	2024-02-01
				I-Apamistamab (Conventional Care (CC))	糧簾鹹窪壓蓋鏇夢鹹餘(淵鹽製餘窪餘範製獵鑰) = 觸構夢衊簾製鬱製膚鬱構築鑰範選獵鹹艱築壓 (觸廠繭網積壓鹹遞遞願 ) 更多
NCT02665065 (SIERRA, Biospace) 人工标引	临床3期	急性髓性白血病 TP53 Mutation	153	Iomab-B (Crossover + TP53 Mutation)	製積範憲窪製鹽築遞鏇(艱觸構繭網襯觸餘壓糧) = 淵夢遞簾範衊鹽窪廠鹽製糧構製構膚製獵製築 (蓋製艱網築衊廠製網繭 ) 更多	积极	2023-12-11
				Control Arm (TP53 Mutation)	製積範憲窪製鹽築遞鏇(艱觸構繭網襯觸餘壓糧) = 範遞壓簾憲醖構築夢壓製糧構製構膚製獵製築 (蓋製艱網築衊廠製網繭 ) 更多
NCT02665065 (SIERRA, ASH2023)	临床3期	急性髓性白血病	153	131I-apamistamab with fludarabine and total body irradiation	範壓窪製蓋鹽餘觸糧觸(鏇醖鏇淵選餘衊蓋遞獵) = 繭鑰獵鏇選夢鬱範構範夢鹽繭淵蓋淵範餘範襯 (襯繭網範願齋製鑰鏇構, 11.5 ~ 22.3) 更多	积极	2023-12-10
NCT02665065 (SIERRA, ASH2023)	临床3期	急性髓性白血病 TP53 mutation positive	153	131I-apamistamab led induction and conditioning followed by alloHCT	艱顧膚襯選窪製壓鹽繭(鏇窪糧鑰遞構蓋膚顧壓) = 窪選艱範鑰繭構網獵鹹齋鏇範淵襯繭廠膚網積 (衊築壓繭製築齋鏇艱選, 12.29 ~ 34.73) 更多	积极	2023-12-10
				physician’s choice of conventional care	獵壓膚襯醖齋簾糧鹽糧(遞窪鏇選構簾遞築遞範) = 積糧鬱襯襯築鹹夢鹹襯積衊願蓋襯築鏇齋繭積 (餘淵鑰鏇遞網壓網鏇窪 )