Drugs / 131I-apamistamab
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04512716 | Feb 2021 → Jan 2027 expected | B-cell lymphoma, unclassifiable, with features intermediate between diffuse large b-cell lymphoma and classical Hodgkin lymphoma, diffuse large B-cell lymphoma activated B-cell type, diffuse large B-cell lymphoma germinal center B-cell type, high grade B-cell lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07015684 | Apr 2025 → Mar 2030 expected | sickle cell disease | Columbia University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2024-06-15 | Immedica Pharma AB | Results Immedica's partner Actinium announces Iomab-B phase 3 SIERRA trial results in patients with TP53 mutation at the EHA 2024 Annual Congress immedica.com ↗
Iomab-B led alloHSCT significantly improved survival outcomes compared to conventional care in this very high-risk patient population with TP53 mutations. |
| 2024-06-10 | Actinium Pharmaceuticals | Results Actinium Highlights Mutation Data from the Phase 3 SIERRA Trial of Iomab-B and Novel Linker Technology to Support Solid Tumor Antibody Radiation Conjugate Development at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting actiniumpharma.com ↗
Iomab-B achieved the primary endpoint of durable Complete Remission (dCR) with high statistical significance (p<0.0001). |
| 2024-05-14 | Actinium Pharmaceuticals | Results Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in TP53 Positive Patients at the EHA 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phase 3 SIERRA Trial actiniumpharma.com ↗
Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002). |
| 2024-04-18 | Actinium Pharmaceuticals | Results Actinium Highlights Ability of Iomab-B to Overcome High-Risk TP53 Mutation Resulting in Significant Improvement in Overall Survival in Patients with Active Relapsed Refractory AML at the European Bone Marrow Transplant Annual Meeting actiniumpharma.com ↗
Iomab-B led bone marrow transplant produced high rates of complete remission and durable complete remission regardless of TP53 mutation status in patients age 55 and above with high-risk active relapsed or refractory acute myeloid leukemia |
| 2024-04-01 | Actinium Pharmaceuticals | Results Actinium Announces Iomab-B Phase 3 SIERRA Trial Results Demonstrating Survival Benefit in High-Risk Relapsed or Refractory Acute Myeloid Leukemia Patients with TP53 Mutations Accepted for Oral Presentation at the 50th European Bone Marrow Transplant Annual Meeting actiniumpharma.com ↗
Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001) and 100% of patients receiving a therapeutic dose of Iomab-B achieved BMT access and engagement. |
| 2024-02-26 | Actinium Pharmaceuticals | Results Actinium Announces Iomab-B Markedly Increases Long Term Survival in Patients 65 Years or Older with Active Relapsed or Refractory AML in the Phase 3 SIERRA Trial at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR® actiniumpharma.com ↗
Active relapsed or refractory AML patients 65+ years receiving an Iomab-B led Bone Marrow Transplant (BMT) achieved significant improvement in survival at one and two years compared to control arm patients none of whom survived even one year |
| 2024-02-23 | Actinium Pharmaceuticals | Results Actinium Highlights Improved Survival with Iomab-B in TP53 Positive Relapsed Refractory Acute Myeloid Leukemia Patients in the SIERRA Trial and Other Presentations at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR® actiniumpharma.com ↗
Iomab-B significantly improved outcomes in TP53 positive patients with a median overall survival of 5.49 months versus 1.66 months in those not receiving Iomab-B (hazard ratio = 0.23, p-value=0.0002) in the Phase 3 SIERRA Trial |
| 2023-12-11 | Actinium Pharmaceuticals | Results Actinium Announces Iomab-B Produces High Response Rates and Significant Improvement in Overall Survival in Relapsed Refractory AML Patients with Active Disease Overcoming TP53 Mutation actiniumpharma.com ↗
The oral presentation highlighted significantly improved survival in patients with a TP53 mutation receiving Iomab-B. |
| 2023-12-11 | Actinium Pharmaceuticals | Results Actinium's Four Presentations at ASH Highlight the Positive Outcomes for Iomab-B and Actimab-A in Patients with Relapsed or Refractory Acute Myeloid Leukemia actiniumpharma.com ↗
Patients receiving Iomab-B had significantly greater median overall survival of 5.49 months compared to 1.66 months in patients on the control arm that received conventional care |
| 2023-12-08 | Actinium Pharmaceuticals | Results Actinium to Highlight Broad Potential of Targeted Radiotherapies Iomab-B and Actimab-A for Relapsed or Refractory and Elderly Acute Myeloid Leukemia Patients at the 65th ASH Annual Meeting & Exposition actiniumpharma.com ↗
131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML |
| 2023-11-14 | Immedica Pharma AB | Results Immedica's partner Actinium announces oral presentation at ASH annual meeting on Iomab-B outcomes data for TP53 gene mutation from the SIERRA trial immedica.com ↗
Median Overall Survival (OS) of patients with TP53 mutation receiving Iomab-B and a hematopoietic stem cell transplantation (HSCT) was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B (hazard ratio=0.23, p=0.0002) |
| 2023-11-02 | Actinium Pharmaceuticals | Results Actinium Announces Oral Presentation at ASH Annual Meeting Highlighting Iomab-B Treatment Significantly Increased Median Overall Survival in Relapsed or Refractory AML Patients with Highly Unfavorable TP53 Gene Mutation in the Phase 3 SIERRA Trial actiniumpharma.com ↗
Relapsed or refractory AML patients with a TP53 mutation receiving Iomab-B led allogeneic bone marrow transplant had a median Overall Survival of 5.49 months compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002) |
| 2023-09-07 | Actinium Pharmaceuticals | Results Actinium Pharma Presents Survival Data from Extended Follow-Up from Actimab-A + CLAG-M Trial and Preclinical Data Supporting Program Expansion with FLT3 Inhibitor Combinations at SOHO actiniumpharma.com ↗
In addition, results of the completed and positive Phase 3 SIERRA trial of Iomab-B were presented. |
| 2023-08-31 | Actinium Pharmaceuticals | Results Actinium Pharma Highlights Three Abstracts Accepted for Poster Presentation at the SOHO 2023 Annual Meeting actiniumpharma.com ↗
The Randomized Phase III SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) Trial: Successful Allogeneic Hematopoietic Stem Cell Transplantation Using Treatment With Iomab-B-Led Regimen for Patients With Active, Relapsed or Refractory AML With Failed Targeted Therapies |
| 2023-06-12 | Actinium Pharmaceuticals | Results Actinium Announces Positive Pivotal Phase 3 SIERRA Trial Results in an Oral Presentation at the EHA 2023 Congress actiniumpharma.com ↗
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, announced positive SIERRA trial results in an oral presentation at the European Hematology Association 2023 Congress (EHA) in Frankfurt, Germany on June 10. |
| 2023-04-28 | Actinium Pharmaceuticals | Results Actinium Highlights Successful Administration of Targeted Radiotherapy Iomab-B Across Various BMT Centers with Ease and Without Increasing Radiation Exposure Risks to Treating Nursing Staff in the Pivotal Phase 3 SIERRA Trial at the 48th Annual Oncology Nursing Society (ONS) Congress actiniumpharma.com ↗
Through education and utilizing Actinium-developed shielding solutions, site personnel became rapidly adept at Iomab-B administration. |
| 2023-04-27 | Actinium Pharmaceuticals | Results Actinium Announces Positive Pivotal Phase 3 SIERRA Trial Results of Iomab-B Showcased to the European Transplant Community in Oral Presentation at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting actiniumpharma.com ↗
Iomab-B met the SIERRA trial primary endpoint of durable Complete Remission (dCR) with high statistical significance (p<0.0001) and had a favorable safety profile compared to the control arm |
| 2023-02-18 | Actinium Pharmaceuticals | Results Actinium Announces Positive Full Data Results From the Pivotal Phase 3 SIERRA Trial in Patients with Active, Relapsed or Refractory Acute Myeloid Leukemia actiniumpharma.com ↗
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive results for the primary and secondary endpoints from its pivotal Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML). |
| 2022-10-31 | Actinium Pharmaceuticals | Results Actinium Announces Positive Top-line Results from Pivotal Phase 3 SIERRA Trial of Iomab-B in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia actiniumpharma.com ↗
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B. |
| 2022-04-25 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals, Inc. Announces 82% of Control Arm Patients Did Not Receive a Bone Marrow Transplant by Conventional Means but 100% of Patients who Received Iomab-B, Including Crossover Patients, in the Phase 3 SIERRA Trial Successfully Engrafted at the Transplantation & Cellular Therapy Tandem Meetings of ASTCT and CIBMTR actiniumpharma.com ↗
100% of patients (66/66) receiving Iomab-B were able to proceed to a bone marrow transplant (BMT) and all achieved engraftment |
| 2022-04-19 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals, Inc. to Highlight Iomab-B Pivotal Phase 3 SIERRA Trial Data at the Transplantation & Cellular Therapy Tandem Meetings of ASTCT and CIBMTR actiniumpharma.com ↗
Data from the SIERRA trial has shown a consistent 100% rate of BMT access and engraftment in all patients receiving Iomab-B |
| 2021-12-13 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals, Inc. Announces Greater Difference of Approximately 5x for Iomab-B vs Control Arm in the Number of Patients Potentially Evaluable for the Primary Endpoint of the Pivotal Phase 3 SIERRA Trial at the 63rd ASH Annual Meeting actiniumpharma.com ↗ |
| 2021-11-04 | Actinium Pharmaceuticals | Results Actinium Announces Multiple Abstracts Highlighting Iomab-B and Actimab-A Accepted for Presentation at the 63rd Annual American Society of Hematology Annual Meeting actiniumpharma.com ↗
Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Active, Relapsed/Refractory AML Patients Not Responding to Targeted Therapies |
| 2021-06-15 | Actinium Pharmaceuticals | Results Pivotal Phase 3 SIERRA Trial Data Showing 100% Bone Marrow Transplant Engraftment in Patients Treated with Iomab-B presented at the 2021 Virtual SNMMI Conference actiniumpharma.com ↗
100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician's choice of salvage therapy on the control arm |
| 2021-06-15 | Actinium Pharmaceuticals | Results Safety Data Highlighting Low Rates of Adverse Events and Non-Relapse Transplant Related Mortality in Patients Receiving Iomab-B Presented at 2021 SNMMI Virtual Conference actiniumpharma.com ↗
The presentation highlighted Iomab-B's targeting ability and corresponding safety data from 113 patients, representing 75% of patient enrollment on the SIERRA trial. |
| 2021-02-11 | Actinium Pharmaceuticals | Results Actinium Showcases Targeted Conditioning Program with 2 Oral Presentations Highlighting Iomab-B and Pivotal Phase 3 SIERRA Trial at 2021 Transplantation & Cellular Therapy Annual Meeting actiniumpharma.com ↗
Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered |
| 2020-12-29 | Actinium Pharmaceuticals | Results Actinium Announces Successful Pre-Planned Ad Hoc Interim Analysis of Phase 3 SIERRA trial actiniumpharma.com ↗
Based on the DMC's review of unblinded data, including the study's primary endpoint of durable Complete Remission (dCR) of at least 180 days, it was recommended that the study continue as planned to full enrollment of 150 patients. |
| 2020-12-07 | Actinium Pharmaceuticals | Results Actinium Announces Positive Interim Results from Iomab-B Pivotal Phase 3 SIERRA Trial at 75% of Total Patient Enrollment at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
In total, 78% (88/113) of patients enrolled on the SIERRA trial were able to receive a BMT despite this being a patient population not typically considered for BMT. |
| 2020-12-07 | Actinium Pharmaceuticals | Results Actinium Highlights Iomab-B Safety Data Presented at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
In addition, patients that crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality. |
| 2020-12-03 | Actinium Pharmaceuticals | Results Actinium Highlights Clinical Data to be Presented at the Upcoming 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered |
| 2020-11-04 | Actinium Pharmaceuticals | Results Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
We are encouraged that we continue to see positive ongoing results from our Phase 3 pivotal SIERRA trial in relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients. |
| 2020-02-21 | Actinium Pharmaceuticals | Results Actinium Presents Positive Findings from Mid-Point Analysis of Pivotal SIERRA Trial of Iomab-B at 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (TCT) actiniumpharma.com ↗
After accounting for these factors, the results showed that, on an intent-to-treat or ITT basis, 78 percent of patients in the Iomab-B arm are potentially evaluable for the primary endpoint compared to 13 percent in the control arm. |
| 2019-12-09 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals Announces Phase 3 SIERRA Trial Dosimetry Results Support Low Dose Iomab-B for Targeted Lymphodepletion Prior to Adoptive Cell Therapy actiniumpharma.com ↗
At this dose level, it expected that an adoptive cell therapy could be administered approximately six days following Iomab-ACT lymphodepletion. |
| 2019-10-28 | Actinium Pharmaceuticals | Results Actinium Announces Positive Interim Results from Iomab-B Pivotal Phase 3 SIERRA Trial at 50% of Total Patient Enrollment actiniumpharma.com ↗ |
| 2019-07-11 | Actinium Pharmaceuticals | Results Actinium Highlights Two Presentations at the Health Physics Society Annual Meeting Supporting the Safety Profile of Iomab-B for SIERRA Trial Caregivers actiniumpharma.com ↗
During HPS, Actinium presented the findings of two studies that support the safety of healthcare professionals who provide care to patients treated with Iomab-B, Actinium's lead product candidate, which is being studied in the pivotal Phase 3 SIERRA trial. |
| 2019-06-20 | Actinium Pharmaceuticals | Results Actinium's Portfolio of Antibody Radiation-Conjugates to be Highlighted in Two Oral and Two Poster Presentations at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting actiniumpharma.com ↗
In addition, findings from a multi-center team suggest that dosimetry imaging optimization may be possible with Iomab-B, which could result in benefits for patients and treatment centers including a reduction in the number and time required for imaging. |
| 2019-06-04 | Actinium Pharmaceuticals | Results Actinium Presents New Pivotal Phase 3 SIERRA Trial Data Showing Rapid Peripheral Blast Reduction and Anti-Leukemic Effect with Single Agent Iomab-B in Older Patients with Active, Relapsed or Refractory Acute Myeloid Leukemia at 2019 ASCO Annual Meeting actiniumpharma.com ↗
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") presented new data from the ongoing pivotal Phase 3 SIERRA study of Iomab-B's single agent effect in patients with active, relapsed or refractory AML or Acute Myeloid Leukemia age 55 and above. |
| 2019-05-16 | Actinium Pharmaceuticals | Results Abstract Highlighting New Data from the Iomab-B Pivotal Phase 3 SIERRA Trial to be Presented at 2019 ASCO Annual Meeting actiniumpharma.com ↗
This significant and rapid reduction in blasts occurred with patients receiving only a single therapeutic infusion of Iomab-B and no other pre-transplant conditioning. |
| 2019-02-25 | Actinium Pharmaceuticals | Results Actinium's Late Breaking Oral Presentation at 2019 TCT Meetings Reports New Data on Donor Chimerism Indicating Deep Engraftment in All Iomab-B Treated Patients in the Pivotal Phase 3 SIERRA Trial actiniumpharma.com ↗
It was reported that all patients who received Iomab-B, received a BMT or Bone Marrow Transplant with 100% (28/28) of patients achieving engraftment and Donor Chimerism. |
| 2019-02-21 | Actinium Pharmaceuticals | Results Actinium Highlights New Data at TCT Meetings Demonstrating Effective Lymphodepletion Supporting Iomab-ACT Program Development for Targeted Conditioning Prior to CAR-T and Adoptive Cell Therapy actiniumpharma.com ↗
Actinium's preclinical studies showed that a single infusion of an anti-CD45 antibody labelled with Iodine-131 can effectively deplete greater than 90% of lymphocytes, including CD4 and CD8 T cells, CD19 B cells and NK cells, which is necessary for adoptive cell therapies like CAR-T to expand and persist. |
| 2018-12-04 | Actinium Pharmaceuticals | Results Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting actiniumpharma.com ↗
Preliminary data strongly support the feasibility and safety of re-induction and targeted conditioning with Iomab-B prior to a BMT. |
| 2018-08-14 | Actinium Pharmaceuticals | Results Actinium to Provide Update on Pivotal Phase 3 SIERRA Trial Following Positive Data Monitoring Committee Meeting actiniumpharma.com ↗
Based on the DMC's unanimous recommendation, we are pleased that the ongoing SIERRA trial will continue as planned, |
All press releases naming this drug 42 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 131I-apamistamab | “131I-apamistamab is a drug construct consisting of the apamistamab monoclonal antibody (mAb) and radioactive isotope iodine 131 (131I).” NCT07015684 ↗ |
| Modality | Monoclonal antibody | “apamistamab monoclonal antibody (mAb)” NCT07015684 ↗ |
| Route | Intravenous | “131I-apamistmab will be given via intravenous (IV) infusion.” NCT07015684 ↗ |