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

Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers (The Manila Times) - "SAdaptive Biotechnologies Corporation...announced that its next-generation sequencing (NGS)-based clonoSEQ test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL)."

Clinical data • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Oncology

Multi-courses of blinatumomab combined with reduced dose chemotherapy has been successfully used in chemo-intolerant middle to high-risk pediatric B-ALL patients with invasive fungal disease. (PubMed, Ann Hematol) - "Symptoms, signs, and imaging findings improved significantly, B-ALL remained in continuous remission in both patients, and no cytokine release syndrome, neurotoxicity, or fungal infection recurrence occurred. These cases suggest that alternating blinatumomab with reduced-dose chemotherapy is both effective and safe for patients with B-ALL suffering life-threatening infections in the setting of ALL therapy."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics

Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=36 | Active, not recruiting | Sponsor: City of Hope Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • PD-L1

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

Unmet need in adults and adolescents and young adults (AYAs) with B-cell acute lymphoblastic leukemia (B-ALL) in the US following a second relapse. (ASCO 2025) - "The most common 3L treatments were multi-agent chemotherapy (155 patients) followed by blin-containing regimens (71 patients) and inotuzumab-containing regimens (56 patients; Table). Half of adults and AYAs with B-ALL who received 1L treatment went on to require 3L treatment. The majority (76%) of patients requiring 3L treatment were AYAs and adults aged 41–64 years. The most common 3L treatment was multi-agent chemotherapy, followed by blin."

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

Cytokine release syndrome among acute lymphocytic leukemia adults undergoing treatment with blinatumomab in the United States. (ASCO 2025) - "In our real-world data, 13.2% of ALL cases undergoing Blinatumomab therapy experienced CRS. The most common form of CRS was grade 1, while grade 2 involved an older group. Furthermore, we confirmed that CRS significantly impacted the healthcare burden among such admissions."

Clinical • Cytokine release syndrome • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Efficacy and safety of combination therapy of ponatinib and blinatumomab in Philadelphia chromosome-positive acute lymphoblastic leukemia: A systematic review and meta-analysis. (ASCO 2025) - "The combination of ponatinib and blinatumomab shows promising results in achieving event-free survival, overall survival, and complete molecular response in Ph+ ALL patients, with a manageable safety profile (16% adverse effects) at 24 months. However, well-defined studies with larger sample sizes are needed for definitive conclusions."

Combination therapy • Retrospective data • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Meta-analysis of the cardiovascular adverse effects of bispecific antibodies in malignant hematology therapies. (ASCO 2025) - "The BsAbs in this analysis were blinatumomab, elranatamab, epcoritamab, glofitamab, mosunetuzumab, talquetamab, and teclistamab and only monotherapy regimens were included. As BsAbs have demonstrated promising efficacy and increased use in the treatment of R/R hematologic malignancies, a wide variety of cardiac toxicities have been observed in these patients and more data on these toxicities are documented. This meta-analysis has identified tachycardia, cardiac arrhythmias, and hypotension as the most significant cardiac adverse events in a pooled analysis of multiple BsAbs. Practicing oncologists, cardiologists, and pharmacists need not only to be aware of these potential toxicities, but also to establish strategies for cardiac monitoring, prevention and management in order to provide quality care to cancer patients."

Adverse events • Retrospective data • Acute Lymphocytic Leukemia • Atrial Fibrillation • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hypertension • Hypotension • Leukemia • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Oncology

Understanding access to novel high-cost therapies across Canada: A survey of pediatric oncology providers. (ASCO 2025) - " This online vignette-based cross-sectional survey of pediatric oncology providers across 16 Canadian centres explored blinatumomab for low-risk relapse of ALL, larotrectinib for TRK-fused soft tissue sarcoma, proton therapy for unresectable head and neck sarcoma, and CT for first relapse of ALL in a patient with Down Syndrome (DS). Our findings demonstrate inequitable access to evidence-informed therapies in Canada. The direct costs of these therapies must be addressed to make them less prohibitive for families; however, strategies must also be developed to mitigate psychosocial and economic impacts of travelling to obtain therapies. Universal funding of these therapies, and simplified access to proton therapy centres, including the development of Canadian proton therapy facilities, would increase equitable access, ultimately improving outcomes for children with cancer."

Clinical • Bone Marrow Transplantation • Developmental Disorders • Genetic Disorders • Oncology • Pediatrics • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • TFG

A phase I study of asciminib in combination with dasatinib, prednisone, and blinatumomab for Ph-positive acute leukemia in adults. (ASCO 2025) - P1 | "Dual ABL1 inhibition with ASC and DAS can be safely combined with blin in Ph+ acute leukemia. An additional 25-pt cohort is planned with blin in combination with DAS and ASC at optimized doses. Response kinetics."

Clinical • Combination therapy • P1 data • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • Respiratory Diseases • IKZF1

Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL). (ASCO 2025) - P2 | "The addition of blinatumomab to frontline chemotherapy improves survival, but regimens used are limited by toxicity and complexity. In a cohort of ND Ph- B-ALL, the addition of tafa to DA-EPOCH ± R led to rates of MRD- that are higher than historical rates, with similar toxicity. Since the target C1 MRD- rate was reached in part 1 of the 2-stage design, the trial is proceeding to part 2 and accrual will be completed. While f/u is short, no relapses have been seen."

Clinical • P2 data • B Cell Lymphoma • Cerebral Hemorrhage • CNS Disorders • Febrile Neutropenia • Hematological Malignancies • Hypotension • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Septic Shock • CD20

Outcomes of Ph-like B-lineage acute lymphoblastic leukemia in the era of novel therapies. (ASCO 2025) - "The remaining 20% of pts received novel therapies in first-line setting, including C10403 + inotuzumab (InO) in 7%, ino + blinatumomab (blin) in 6%, hyperCVD + venetoclax in 4% and C10403 + imatinib in 3%...Of note, 5 pts received kinase inhibitors (ruxolutinib, dasatinib, imatinib) in salvage setting, but did not achieve remission... Ph-like B-ALL pts treated with standard chemo have lower CR and RFS rates. Adding novel agents (InO, blin, venetoclax) to upfront regimens may improve outcomes. Future studies should focus on optimal first-line combinations and higher-risk groups such as KRAS-mutated Ph-like B-ALL."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • ABL2 • CDKN2A • CRLF2 • CSF1R • FGFR • IKZF1 • JAK2 • KRAS • NRAS • PAX5 • ROS1

Efficacy and safety outcomes of obecabtagene autoleucel (obe-cel) stratified by age in patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). (ASCO 2025) - P1/2 | "A higher proportion of pts aged <55 yrs were Hispanic/Latino (36.7% vs 18.8%), had extramedullary disease at lymphodepletion (LD; 29.1% vs 8.3%), received prior blinatumomab (53.2% vs 22.9%), and prior inotuzumab ozogamicin (35.4% vs 25.0%) than those ≥55 yrs, while a higher proportion of pts aged ≥55 yrs had Philadelphia chromosome-positive disease (47.9% vs 16.5%)... Obe-cel treatment resulted in favorable ORR and EFS with low Grade ≥3 CRS/ICANS incidence in both age groups. These findings indicate that obe-cel is effective and has a positive benefit/risk profile regardless of age, including in older adults with R/R B-ALL despite few receiving consolidative SCT."

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

Impact of TP53 mutations and variant allelic frequency on survival in adults with newly diagnosed acute lymphoblastic leukemia. (ASCO 2025) - "In older pts who received frontline inotuzumab ozogamicin (InO) and/or blinatumumab (Blina), TP53 VAF ≥45% remained a strong predictor of OS (2-year OS 37% vs. 75% for VAF <45%; p=0.04). TP53 mutations were associated with worse outcomes in both younger and older adults with ALL. VAF ≥45% can risk stratify pts aged ≥60 years but did not impact OS in younger pts. Incorporating frontline InO and/or Blina into therapy might improve outcomes of TP53-mutated ALL."

Clinical • Tumor mutational burden • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • TMB • TP53

Treatment patterns and out-of-pocket cost after CAR-T cell therapy in commercially insured patients with hematologic malignancies: A real-world US study. (ASCO 2025) - "After CAR-T failure, the most common first-line therapies were lenalidomide (n=12), ibrutinib (n=7), and pembrolizumab (n=5) for DLBCL, and blinatumomab (n=3) and ruxolitinib (n=2) for ALL. This study highlights a substantial risk of CAR-T failure, with targeted therapies and immunotherapies commonly used post-CAR-T. OOP costs were significant, particularly for patients requiring additional therapy, with considerable variability. These findings emphasize the need for strategies to improve outcomes and reduce financial toxicity in this population."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Epigenetic and phenotypic signatures of T-cell response to blinatumomab in pediatric relapsed and refractory B-ALL. (ASCO 2025) - "Blinatumomab therapy in pediatric B-ALL patients induced variable epigenetic and phenotypic changes to the T cell compartment indicative of exhaustion, corresponding to differences in T cell expansion and persistence between patients. Our study is the first to link epigenetic changes in exhaustion regulators with response variability in blinatumomab-treated patients. Furthermore, our findings highlight a potential role of baseline T cell composition and tumor burden in determining therapeutic outcomes."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD8 • HAVCR2 • IKZF1

Barriers to Blinatumomab Administration and Access: How to Overcome Them (ASCO 2025) - No abstract available

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

Who Would and Would Not Benefit From Receiving Blinatumomab in Frontline Treatment of B-Cell Acute Lymphoblastic Leukemia (ASCO 2025) - No abstract available

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

Navigating B-Acute Lymphoblastic Leukemia in the Era of Blinatumomab (ASCO 2025) - "In the last year, pivotal new trial results from the Children's Oncology Group have upended the standard of care treatment of patients with B-ALL. Faculty will discuss how treatment paradigms have changed for different subpopulations of patients with B-ALL; the barriers patients and institutions face in delivering blinatumomab, and the future of treatment for B-ALL"

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

KT501, A CD19, BCMA-DIRECTED T-CELL ENGAGER (TCE), LEADS TO DEEP B-CELL DEPLETION AND MINIMAL CYTOKINE RELEASE IN VIVO (EULAR 2025) - "Background: B cell depletion therapies targeting CD19 or BCMA, including Chimeric antigen receptor T-cell (CAR-T) therapies and Bispecific antibody such as blinatumomab and Teclistamab, had shown impressive efficacy in treating B cell malignancy. Those preclinical data strongly support clinical development of KT501 in autoimmune disease treatment, which is expected to move into Phase I trial in Q4, 2025."

Preclinical • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

SAFETY AND EFFICACY OF T CELL ENGAGER THERAPY IN PATIENTS WITH REFRACTORY AUTOIMMUNE DISEASE (EULAR 2025) - "14 patients with rheumatoid arthritis (RA) were treated with the CD19xCD3 TCE blinatumomab, while 10 patients (systemic sclerosis (SSc), N=3, idiopathic inflammatory myositis (IIM) N=2, IgG4-related disease (IgG4-RD) N=2, primary Sjoegren’s-Syndrome (SjS) N=1, Graves disease (GD) N=1,) and RA N=1) were treated with the plasma cells targeting BCMAxCD3 TCE teclistamab. Together, these results substantiate the feasibility of TCE treatment of to autoimmune disease. Most notable adverse events are low grade cytokine release syndrome and infections. Short term efficacy is high even in a refractory patient population, however relapses occur."

Clinical • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Grave’s Disease • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Myositis • Nephrology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis • IFIH1

Applications for SLE patient-derived PBMC-induced mouse model in preclinical pharmacological studies (EULAR 2025) - "In case 2, the T cell engager under test and positive control, Blincyto, were administered intravenously 7 days after PBMC inoculation, twice a week for three consecutive weeks... SLE patient-derived PBMC-induced mouse model exhibits similar pathological features seen in SLE patients such as high levels of autoantibodies and pathogenic B cells. It demonstrates good responses to B-cell directed therapeutic antibodies and cell therapies in pharmacological studies and offers a clinically relevant animal model to accelerate the development of novel therapies ."

Preclinical • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD20

Treatment of severe systemic sclerosis with blinatumomab, a bispecific anti-CD3/CD19 T cell engager (EULAR 2025) - "We present the first cases worldwide in which blinatumomab was used as a B-cell-depleting therapy in a non-malignant disease. Blinatumomab was safe with transient neutropenia in one of the three patients and resulted in profound B-cell depletion and a significant decrease in serum IgG. Remarkably, this did not lead to increased susceptibility to infections."

Cardiovascular • Fibrosis • Immunology • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Orthopedics • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

The use of the CD3/CD19 T cell engager blinatumomab in severe systemic sclerosis : a case series (EULAR 2025) - "The treatment protocol included premedication with hydrocortisone (100 mg), paracetamol (1 g), and dexchlorpheniramine (5 mg), followed by continuous intravenous infusion of blinatumomab at 9 µg/day for 7 days, then 28 µg/day for another 7 days. This real-world study indicates that blinatumomab is safe for use in systemic sclerosis and may lead to clinically significant improvements, including benefits for skin and lung manifestations."

Clinical • Cardiovascular • Fatigue • Fibrosis • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

Induction of GC-free remission by the bispecific CD19xCD3 T cell engager blinatumomab in patients with severe, therapy-refractory anti-synthetase syndrome (EULAR 2025) - "All patients were anti-Jo1 antibody positive and were not responding to multiple immunosuppressive therapies including prednisone, immunoglobulins, rituximab. Treatment with blinatumomab induced rapid, glucocorticoid-free remission of myositis in all patients and improvement of all other manifestations. Blinatumomab may thus offer potential for induction of remission in treatment-refractory ASyS patients."

Clinical • Cardiovascular • Immunology • Infectious Disease • Inflammation • Myositis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • CD20