Drugs / apamistamab
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT07157514 | Jan 2026 → Feb 2029 expected | acute myeloid leukemia, disease related to transplantation | Actinium Pharmaceuticals | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2024-02-23 | 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 |
| 2023-11-02 | 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) |
| 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. |
| 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. |
| 2019-06-25 | Actinium Pharmaceuticals | Results Actinium Presents New Data Demonstrating Effective Lymphodepletion with Lutetium-177 for CAR-T at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting actiniumpharma.com ↗
In vivo animal studies demonstrated that a Lu-177 labeled CD45 ARC transiently depleted CD45 positive immune cells while sparing platelets, red blood cells and bone marrow cells. |
| 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. |
| 2019-05-16 | 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. |
All press releases naming this drug 19 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | apamistamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07157514 ↗ |
| Modality | Monoclonal antibody | “Iodine-131 radiolabeled anti-CD45 monoclonal antibody” NCT07157514 ↗ |
| Route | Intravenous | “Administered IV as a dosimetric dose followed by treatment dose.” NCT07157514 ↗ |