Immedica’s partner Actinium announces oral presentation at ASH annual meeting on Iomab-B outcomes data for TP53 gene mutation from the SIERRA trial
Stockholm, November 14 , 2023 – Immedica’s partner Actinium Pharmaceuticals, Inc. has announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65th Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in the abstract include the following:
- 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)
- Median OS of patients without TP53 mutation receiving Iomab-B was 6.37 months and for patients with TP53 mutation it was 5.72 months, demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations
- 24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm
Detailed results will be presented in an oral presentation on December 10, 2023, as follows:
Publication Number: 469
Title: 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML
Submission ID: 182177
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Novel Conditioning Regimens for Myeloid Malignancies
Session Date: Sunday, December 10, 2023
Session Time: 9:30 – 11:00 AM Pacific Time
Presentation Time: 9:30 AM
Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19
Additional SIERRA data will be presented in two poster presentations as follows:
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster I
Session Date: Saturday, December 9, 2023
Presentation Time: 5:30 – 7:30 PM Pacific Time
Location: San Diego Convention Center, Halls G-H
Publication Number: 2159
Title: 131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 – 8:00 PM Pacific Time
Location: San Diego Convention Center, Halls G-H
Publication Number: 3529
Title: High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML
About Actinium Pharmaceuticals, Inc.
Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium's technology platform is the basis for collaborations with Astellas Pharma and AVEO Oncology/LG Chem Life Sciences for solid tumors. Actinium holds more than 220 patents and patent applications.
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 by the investment company Impilo and Buy-in-Management. Today Immedica employs more than 100 people across Europe and the Middle East.
For more information visit www.immedica.com
Immedica contact:
Linda Holmström
Head of Communication
linda.holmstrom@immedica.com
+ 46 708 73 40 95
Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm
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