Blincyto (blinatumomab) / Astellas, Amgen, BeOne Medicines - LARVOL DELTA

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: St. Jude Children's Research Hospital

New P1 trial • Hematological Malignancies • Oncology • Transplantation

Creating a Blinatumomab Care Guideline to Improve Ǫuality of Care in Patients Receiving Blinatumomab (APHON 2025) - No abstract available

Clinical

Expert Nursing Care and Coordination in Blinatumomab Delivery: A Children's Oncology Group Perspective (APHON 2025) - No abstract available

Clinical • Oncology

Evaluating TCE drug-cytokine detection in vitro (News-Medical) - "Use Human PBMC cells as effector cells and GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads (ACROBiosystems, Cat. No. GMP-MBS001) to expand T cells. On Day 10, FACS-sort CD3+ T cells and co-culture them with Raji cells. Then, stimulate with various concentrations of TCE bispecific antibody (Blinatumomab). The TCE bispecific antibody binds to both TCR/CD3 on effector cells and tumor antigens on target cells. TCE binding leads to the release of IFN-γ, IL-6, and IL-10. Collect cell supernatants at 0, 24, and 48 hours and use ClinMax™ Human Cytokines ELISA Kit to evaluate cytokine levels...Co-cultured effector and target cells at an E:T ratio of 1:10 or 1:5 leads to increased IFN-γ release with drug concentration."

Preclinical • Hematological Malignancies

AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P2 | N=461 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting | N=300 ➔ 461

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Oncology • CD19

Efficacy of Blinatumomab in the Treatment of Pediatric B-cell Acute Lymphoblastic Leukemia (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "Blinatumomab can be used as a safe and effective treatment for inducing deep remission in pediatric R/R-ALL patients and as a bridge therapy for the pediatric ALL patients who are intolerant to chemotherapy."

Journal • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Pediatrics • Transplantation

Blinatumomab in Pediatric B-acute Lymphoblastic Leukemia (Frontiers) - "As one of the representatives of cutting-edge immunotherapy for pediatric ALL, blinatumomab plays a crucial role in precision medicine against the backdrop of current genetic testing. Clinical efficacy is influenced by factors such as tumor burden, endogenous T-cell function, CD19 antigen loss, and lineage switch. Treatment-related complications, such as cytokine release syndrome (CRS), neurotoxicity (ICANS), and infections, necessitate vigilant monitoring. Administration involves continuous intravenous infusion, with consideration for drug interactions. Despite proven short-term efficacy and tolerability, long-term impacts on pediatric patients warrant further investigation. Current studies refine dosing strategies and combinational approaches to enhance therapeutic precision for pediatric patients. This review synthesizes selected literature related to clinical trials of blinatumomab, emphasizing determinants of clinical efficacy and adverse events associated with treatment."

Review • B Acute Lymphoblastic Leukemia

Efficacy or convenience? Subcutaneous blinatumomab as a promising new treatment for B-cell acute lymphoblastic leukaemia. (PubMed, Lancet Haematol) - No abstract available

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov) - P2 | N=2 | Completed | Sponsor: University of Maryland, Baltimore | Active, not recruiting ➔ Completed | Trial completion date: Aug 2027 ➔ May 2025

Minimal residual disease • Trial completion • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CD19xCD3 T-cell engager blinatumomab effective in refractory generalized myasthenic syndromes. (PubMed, Mol Ther) - "Both patients experienced grade 1 cytokine release syndrome during initial treatment phases, but no neurotoxicity or severe adverse events were observed. This report underscores the potential of CD19xCD3 T-cell engagers as a promising therapeutic approach in severe autoimmune neuroimmunological disorders, warranting further investigation in clinical trials and mechanistic studies."

IO biomarker • Journal • CNS Disorders • Immunology • Inflammation • Myasthenia Gravis

Moving the Needle in KMT2A Rearranged Pediatric B-Cell Acute Lymphoblastic Leukemia: Newer agents and novel approaches. (PubMed, Clin Hematol Int) - "Recent clinical trials have shown a significant improvement in response rates and survival outcomes in infantile and pediatric non-infant patients with KMT2A-r B-ALL when treated with blinatumomab-containing regimens...In the salvage settings the use of tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy has led to high response rates and durable remissions in pediatric KMT2A-r B-ALL. Recently, inotuzumab ozogamicin was approved in pediatric (>1 year) relapsed/refractory B-ALL, widening immunotherapy-based salvage options...Additionally, the approval of menin inhibitors like revumenib in KMT2A-r pediatric acute leukemias provides another treatment option in the salvage setting for this high-risk pediatric B-ALL subtype. These targeted agents are positively altering the treatment approaches and outcomes in pediatric KMT2A-r B-ALL, and the use of better residual disease monitoring with next generation sequencing might further help to refine treatment..."

IO biomarker • Journal • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD22 • KMT2A

First-Line Postremission Blinatumomab as Successful Toxicity-Sparing Strategy in a Boy with Cystic Fibrosis and Acute Lymphoblastic Leukemia. (PubMed, Pediatr Blood Cancer) - No abstract available

Journal • Acute Lymphocytic Leukemia • Cystic Fibrosis • Genetic Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Pediatrics • Pulmonary Disease • Respiratory Diseases

ADDITION OF BLINATUMOMAB TO CONSOLIDATION THERAPY FOR YOUNGER ADULTS (BCR:ABL1-NEGATIVE B-ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) ON THE ECOG-ACRIN E1910 PHASE III TRIAL (EHA 2025) - "Estimates of OS and RFS were calculated using the Kaplan-Meier method and comparison between treatment arms was conducted using the two-sided stratified log-rank test and Cox model with stratification factors CD20 status, rituximab use, and whether pts intended to receive transplant (HCT).Across the 488 enrolled pts, 277 were < 55 years old with median age of 42 (range 30-54), 48% were female,78% were White, and 18% were Hispanic. E1910 demonstrates significant improvement in OS and RFS in MRD- young adults who receive blina and chemo in consolidation, despite more patients with high risk disease. These results and pediatric data suggest that blina should be incorporated into the care of all adolescents and young adults with B ALL. Future studies should evaluate the potential to increase MRD negativity and decrease the use of chemo and HCT."

Clinical • P3 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Septic Shock • ABL1 • CD20 • KMT2A

CLINICAL CHARACTERISTICS AND OVERALL SURVIVAL OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA. A STUDY FROM THE GRELAL-CHILE EPIDEMIOLOGIC REGISTRY. (EHA 2025) - "Induction treatment was hyper-CVAD with or without rituximab (53.6%)...20 inotuzumab and 5 blinatumomab... Use of intensified pediatric regimens, adherence to proven effective new medications, and improved supportive care are necessary to improve survival rates in these patients."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics

Assessing the risk of cytokine release syndrome associated with the use of antineoplastic agents: A real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database (FAERS). (ASCO 2025) - " Among the top 10 drugs associated with CRS, CAR-T therapies exhibited the strongest disproportionality signals, with Axicabtagene Ciloleucel (ROR: 1946.596, PRR: 1104.019), Tisagenlecleucel (ROR: 1541.613, PRR: 908.159), and Brexucabtagene Autoleucel (ROR: 1385.781, PRR: 815.937) ranking highest...Blinatumomab (ROR: 216.203, PRR: 195.902), a BiTE therapy, ranked fourth, reflecting a moderate but significant CRS signal. Fludarabine (ROR: 128.879, PRR: 121.137), an immunosuppressive agent used in lymphodepleting regimens before CAR-T therapy, also exhibited a notable CRS association, likely due to its role in enhancing immune cell expansion. Traditional chemotherapy agents demonstrated lower CRS signals, with Cyclophosphamide (ROR: 26.215, PRR: 25.886) and monoclonal antibody Rituximab (ROR: 6.973, PRR: 6.952) showing relatively modest disproportionality. Corticosteroids, which are commonly used to mitigate CRS symptoms, had the lowest disproportionality signals, with..."

Adverse events • Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Inflammation • Oncology

A BISPECIFIC ANTI-FLUORESCEIN X ANTI-CD3 T-CELL ENGAGER ANTIBODY IN COMBINATION WITH FLUORESCEINATED ADAPTORS ENABLES LYSIS OF NEOPLASTIC CELLS (EHA 2025) - "We engineered a bispecific T-cell engager (AdFITC-TCE) by combining sequences from the fully human anti-fluorescein antibody E2 and the anti-human CD3 antibody OKT3 into a tandem single-chain variable fragment format, analogous to the design of blinatumomab. We generated antibody adaptors by conjugating fluorescein to diabodies against CD33 and CD117 and to the clinical-grade IgGs rituximab (anti-CD20) and daratumumab (anti-CD38)... Collectively, these data demonstrate that AdFITC-TCE, in combination with fluoresceinated antibody binders, activates T-cells, leading to respective target cell lysis. In theory, this approach would allow the use of any cell surface binder that can be fluoresceinated as an adaptor for T-cell mediated lysis of target cells."

Combination therapy • Acute Myelogenous Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD33 • CD3E • KIT

Anti-CD19 therapy (Blinatumomab®) as a bridge therapy for hematopoietic stem cell transplantation in pediatric patients with relapsed/refractory B-type acute lymphoblastic leukemia Ph-negative (EACR 2025) - "Although our study had some limitations regarding its retrospective design and the limited patient population, the response rate in our cohort demonstrated that Blinatumomab® has a tolerable toxicity profile, providing hope for improvements in cure rates."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Pediatrics • Transplantation

Outcomes of Haploidentical Stem Cell Transplantation for Acute Lymphoblastic Leukemia Patients: A Single-Center Experience in Mexico. (PubMed, Transplant Cell Ther) - "This study demonstrates that haplo-SCT using modern protocols yields favorable outcomes in a resource-limited Mexican setting, supporting its broader adoption in LMICs. Long-term survival was comparable to outcomes reported in high-income countries, highlighting the feasibility and scalability of this strategy."

Journal • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Pediatrics • Transplantation

Elderly Acute Lymphoblastic Leukemia: Low-Dose Chemotherapy and Immunotherapy Combinations. (PubMed, Clin Lymphoma Myeloma Leuk) - "The manuscript will sequentially consider Philadelphia chromosome (Ph) negative ALL, then Ph+ and finally T-ALL. Accordingly, novel strategies using chemo-free approaches and new drugs such as inotuzumab ozogamicin, blinatumomab, venetoclax, tyrosine kinase inhibitors and CAR T-cells will be discussed."

Journal • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

REAL-WORLD DATA ON INOTUZUMAB OZOGAMICIN FOR ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA: A GRELAL-CHILE STUDY (EHA 2025) - "Duration of Response was 10.4 months, Mean OS from the use of the drug to death was 8.8 months, PFS 6.9 months, four patients received blinatumomab at some point in their treatment, and there was no difference between the two groups (p=0.5). We present a local experience using InO in Chile. We observed OS and PFS similar to other reports; VOD was higher, but in almost all cases, it was a mild disease. The best outcomes were seen in patients who achieved negative MRD and received ASCT after InO."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Hepatology • Leukemia • Oncology • ABL1 • BCR

A QUALITY-ADJUSTED SURVIVAL ANALYSIS IN ADULT AND ELDERLY PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA: COMPARING REDUCED-INTENSITY AND FULL-DOSE CHEMOTHERAPY REGIMENS (EHA 2025) - "Non-randomized trials combining reduced-intensity chemotherapy with targeted therapies such as blinatumomab and inotuzumab ozogamicin have shown promise, but these therapies are not approved in this setting. Survival for adults aged ≥50 years with ALL treated with chemotherapy remains poor, with median OS <1 year. Reduced-intensity regimens yielded no OS advantage compared to full-dose regimens but were associated with improved quality-adjusted survival (+158.2% Q-TWiST). Pending the approval of targeted therapies for frontline treatment, reduced-intensity chemotherapy regimens may enhance quality of life in this population."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

SECOND ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR RELAPSED ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOMA IN THE ERA OF IMMUNOTHERAPY: OUTCOMES AND PROGNOSTIC RISK FACTORS (EHA 2025) - "Immunotherapies such as chimeric antigen receptor T-cell (CAR-T), blinatumomab, and inotuzumab ozogamicin have emerged as powerful tools to achieve complete remission (CR) then bridging to the second allo-HSCT for this setting...Conditioning regimens included total body irradiation (TBI)/fludarabine-based (n=66), busulfan/fludarabine-based (n=14), busulfan/cyclophosphamide-based (n=2),and total marrow irradiation (TMI)/fludarabine-based (n=3)... Our findings highlight the feasibility of the second allo-HSCT in ALL/LBL patients who relapsed after the first allo-HSCT. TBI-based conditioning regimens and achieving CR before the second HSCT are favorable factors for improving OS and RFS. Relapse remains the main cause of death."

Clinical • IO biomarker • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • ABL1 • BCR • TP53

Maximizing the impact of blinatumomab: protocol integration and best practices (EHA 2025) - "Sponsored by Amgen"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

FIVE-YEAR SURVIVAL OUTCOMES OF PATIENTS (PTS) WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) TREATED WITH BREXUCABTAGENE AUTOLEUCEL (BREXU-CEL) IN ZUMA-3 (EHA 2025) - "The median follow-up time for pts ≥26 y (n=63) was 65.6 mo (range, 56.7-94.3); median OS remained unchanged since the 4-y analysis at 26.0 mo (95% CI, 15.9-NE) with a 5-y OS rate of 42% (95% CI, 28.6-53.9).The 5-y OS rates (95% CI) for pts with (n=38) and without (n=40) prior blinatumomab were 25% (12.1-40.4) and 54% (36.3-68.5); for pts with (n=17) and without (n=61) prior inotuzumab were 21% (5.2-43.9) and 45% (31.1-57.4); and for pts with (n=29) and without (n=49) prior allogeneic stem cell transplantation (alloSCT) were 36% (17.1-55.3) and 42% (26.9-55.5), respectively. Pts in ZUMA-3 continued to experience a survival benefit with a 40% 5-y OS rate. Responders had the greatest benefit with a median OS of >5 y (CR/CRi) and not reached in those with CR. Pts benefitted regardless of age, prior therapy, or subsequent alloSCT status, though small subgroups and unbalanced pt characteristics limit interpretation of post hoc subgroup analyses."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Cervical Cancer • Hematological Malignancies • Leukemia • Oncology • Respiratory Diseases • Solid Tumor

DETERMINANTS OF SURVIVAL IN ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: A DECADE OF EXPERIENCE IN NORTHEASTERN COLOMBIA (EHA 2025) - "HSCT, blinatumomab, and maintenance chemotherapy improve survival in patients with ALL, while the presence of comorbidities, refractoriness, and relapses are associated with a worse prognosis."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Diabetes • Hematological Malignancies • Leukemia • Metabolic Disorders • Oncology • T Acute Lymphoblastic Leukemia