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

Efficacy and safety profile of inaticabtagene autoleucel in Chinese patients with Philadelphia chromosome-positive b-ALL: Insights from real-world data (ASH 2025) - P | "Prior therapies included hematopoietic stem cell transplantation (HSCT) (24.1%), inotuzumab ozogamicin (14.8%), and blinatumomab (24.1%)...The median infusion dose was 0.60 (range: 0.44–1.00) × 10 8 viable CAR-T cells, with 88.9% of patients receiving bridge therapy...All patients recovered without sequelae: 9 received corticosteroids, and 11 received tocilizumab. Conclusion Real-world data demonstrate that Inati-cel exhibits excellent efficacy in patients with Ph+ B-ALL, yielding low toxicity, short treatment cycles, high complete molecular response rates, and favorable long-term survival. Extended follow-up could illuminate the long-term outcomes of Inati-cel use."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Hematological Malignancies • Leukemia • ABL1 • IKZF1

Efficacy and safety profile of inaticabtagene autoleucel in Chinese adult patients with B-cell acute lymphoblastic leukemia who relapsed after their transplant: Insights from real-world data (ASH 2025) - P | "The median infusion dose was 0.60 (range: 0.42–1.00) × 10 8 viable CAR-T cells...Patients with and without prior blinatumomab exposure had similar OS (p = 0.62) and RFS (p = 0.58); the same was true for prior inotuzumab ozogamicin exposure (p = 0.86 and p = 0.67, respectively)...Conclusion Real-world data demonstrate that Inati-cel exhibits excellent efficacy in patients with B-ALL who relapse after HSCT and in patients with active extramedullary disease; its safety was also established. Extended follow-up is warranted to fully characterize the long-term outcomes of Inati-cel use."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Transplantation • IKZF1 • TP53

Efficacy and safety profile of inaticabtagene autoleucel in Chinese patients with B-cell acute lymphoblastic leukemia: Insights from real-world data (ASH 2025) - P | "Prior immunotherapies included: HSCT(21.4%), inotuzumab ozogamicin (18.6%), and blinatumomab (28.3%)...All patients recovered without sequelae, with 38 treatedwith corticosteroids, and 33 with tocilizumab or siltuximab.Real-world data on Inati-cel corroborates its robust response rate, favorable toxicity profile, and survivalbenefits. Real-world data on Inati-cel corroborates its robust response rate, favorable toxicity profile, and survivalbenefits. Inati-cel demonstrates efficacy in patients with active extramedullary diseases, particularlythose with CNSL. In vivo expansion was observed across different disease states."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • CD4 • CD8 • IKZF1 • KMT2A • PAX5 • TP53

Real-world efficacy of inaticabtagene autoleucel in adult B-cell acute lymphoblastic leukemia patients with high-risk molecular alterations (ASH 2025) - P | "The CR1-MRD⁻ group exhibited a trend toward superior median RFS compared to the combined CR1-MRD⁺ and R/R group (not reached vs. 404 days [95% CI: 30-777 days], P=0.073).In terms of post-CAR-T management, 20 patients received combination therapy (including three patients received tyrosine kinase inhibitors, one patients received zanubrutinib, two patients received pomalidomide, three patients received venetoclax, one patients received blinatumomab, one patients received inotuzumab ozogamicin, and four patients received allo-HSCT), while 21 patients underwent observation only. Front-line consolidation with CAR-T during CR1-MRD⁻ in patients with high-risk molecular alterations may yield better RFS outcomes compared to treatment administered in R/R or MRD⁺ settings. No RFS benefit from post-CAR-T combination therapy was observed in this cohort, highlighting the need for validation with longer follow-up durations and larger patient cohorts."

Clinical • IO biomarker • Real-world • Real-world effectiveness • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • IKZF1 • KMT2A • TP53

Cardiovascular adverse events associated with bispecific antibodies in Relapsed/Refractory hematologic malignancies: A comprehensive systematic review and meta-analysis (ASH 2025) - "The study included seven bispecific antibodies (BsAbs) : blinatumomab , mosunetuzumab , elranatamab , epcoritamab , glofitamab , talquetamab , and teclistamab . While bispecific antibodies (BsAbs) show promising results in managing R/R hematologic malignancies, their use can lead to significant cardiac adverse effects, including tachycardia, arrhythmias, and hypotension. To mitigate these risks, a multidisciplinary approach—incorporating vigilant cardiac monitoring, preventive strategies, and prompt intervention—is essential for optimizing patient care and treatment success. Risk of Bias was relatively low."

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

Incidence of second primary malignancies (SPMs) following bispecific antibody (BsAb) therapy for lymphoid malignancies: A descriptive analysis of clinical trials (ASH 2025) - "Included agents were blinatumomab (CD19×CD3), glofitamab, mosunetuzumab, epcoritamab, and odronextamab (all CD20×CD3), as well as elranatamab, teclistamab, and linvoseltamab (BCMA×CD3), and talquetamab (GPRC5DxCD3). Notably, some reported cases may represent disease progression rather than true SPMs. However, limited follow-up duration across trials warrants continued long-term surveillance, particularly as agents move to frontline settings where longer survival may reveal delayed malignancies."

Clinical • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lung Cancer • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Comparative analysis of fatal serious adverse events associated with FDA-approved bispecific antibodies in hematologic malignancies (ASH 2025) - " Using the FDA Adverse Events Reporting System (FAERS) public dashboard case-listing feature up to Q2 2025, individual reports listings with death as an outcome were extracted for all FDA-approved BsAbs/BiTEs: blinatumomab, glofitamab, epcoritamab, teclistamab, elranatamab, and talquetamab. The FAERS-based analysis aligns with literature on BsAb/BiTEs toxicities: CRS and infections are consistently reported fatal SAEs, with ICANS more notable in BCMA-targeting agents. Notably, our study also reveals underappreciated signals: cardiovascular fatal events, rare neurological syndromes beyond ICANS, and opportunistic infections—which are not prominently featured in the literature but appear in real-world fatal outcomes. These findings highlight both expected and emerging fatal toxicity patterns across FDA-approved BiTEs/BiAbs."

Adverse events • Serious adverse event • Acute Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Leukemia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Cardiovascular safety profile of CD20 × CD3 bispecific antibodies compared to immune-checkpoint inhibitors: A faers analysis, 2014–2025 (ASH 2025) - "Background: Bispecific T-cell engagers (BTEs) have evolved from CD19 × CD3 constructs such as blinatumomab to newer CD20 × CD3 agents, including mosunetuzumab, glofitamab, and epcoritamab. CD20 × CD3 bispecifics are associated with a distinct arrythmia signal, more frequent and earlier than that observed with ICIs. However, overall arrhythmia reporting has declined over time, likely reflecting improved mitigation strategies such as step-up dosing and early monitoring. Nonetheless, the absolute incidence (2.8%) exceeds that seen with ICIs, supporting baseline ECG and rhythm surveillance during CD20 BTE initiation."

Checkpoint inhibition • Clinical • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Inflammation • Oncology • Venous Thromboembolism • CD20 • ROR1

Real-world descriptive analysis of the use of bispecific t cell engagers (BiTEs) in the treatment of hematological malignancies in Qatar: A state-wide retrospective cohort study (ASH 2025) - "Nevertheless, in r/r multiple myeloma (MM) elranatamab and teclistamab have been used to target BCMA. Another BiTE targeting CD20 used in r/r follicular lymphoma (FL) such as mosunetuzumab, and glofitamab in r/r diffuse large B cell lymphoma (DLBCL), while epcoritamab has been approved in both indications (Shouse G., 2025)...Method This is a descriptive retrospective cohort study, including all adult hematological patients who were treated with BiTEs: epcoritamab, glofitamab, blinatumomab, and teclistamab...Despite the small sample size and the study design, our findings nearly comply with primary literature that BiTEs serve as a promising therapeutic alternative for patients with relapsed or refractory disease, particularly those who have exhausted other modalities. However, the high incidence of reported adverse drug reactions (ADRs), including severe toxicities such as CRS and ICANS, highlights the need for robust and careful strategies for safety and tolerability..."

Real-world • Real-world evidence • Retrospective data • Acute Lymphocytic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Clinical outcomes and novel therapeutic strategies in adult patients with MLL-rearranged acute lymphoblastic leukemia: A monocentric retrospective analysis (ASH 2025) - "While the efficacy of blinatumomab and CAR-T therapy has been established in relapsed/refractory B-ALL, clinical studies in adult patients with newly diagnosed MLL-r B-ALL remained limited... Dynamic MRD-directed sequential immunotherapy overcame chemo-resistance in MLL-r B-ALL, achieved molecular responses and long-term survival . MLL transcript clearance is a critical biomarker for cure, validating this paradigm as a new standard of care."

Clinical data • IO biomarker • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia

Blinatumomab plus dasatinib in a dialysis-dependent patient with ph-positive B-ALL: Durable MRD-negative remission (ASH 2025) - "To date, the literature is limited to isolated reports of reduced-dose imatinib or dasatinib monotherapy in dialysis patients. After cycle 1 the patient achieved MRD-positive complete remission (BCR-ABL1/ABL1 ratio 0.019%, 3.6-log reduction). Following cycle 2, bone-marrow biopsy demonstrated MRD-negative complete remission with undetectable BCR-ABL1. Serial lumbar punctures remained negative."

Clinical • Minimal residual disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Mucositis • Nephrology • Renal Disease • Respiratory Diseases • Septic Shock • ABL1 • BCR • IKZF1

upfront use of blinatumomab in adolescents and adults with Philadelphia Chromosome–Negative B-cell acute lymphoblastic leukemia: A systematic review and proportional meta-analysis (ASH 2025) - "Blinatumomab-based regimens in the frontline setting are associated with high MRD clearance and complete remission rates, particularly when used during induction or consolidation. However, the predominance of non-randomized studies, small sample sizes, and heterogeneity in MRD assessment limit definitive conclusions. Prospective randomized trials are needed to clarify the optimal integration of blinatumomab in frontline Ph– B-ALL therapy."

Retrospective data • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Safety and efficacy of consolidation-Phase blinatumomab in newly diagnosed B-cell acute lymphoblastic leukemia : A systematic review and meta-analysis (ASH 2025) - "Consolidation-phase blinatumomab is associated with high response rates and a favorable safety profile, reinforcing the survival gains observed in E1910 (3-year OS: 83% vs 65%). With low rates of treatment-limiting toxicity and mortality, our findings support the incorporation of blinatumomab into standard adult B-ALL consolidation regimens. These data suggest that this immunotherapeutic approach may help narrow the outcome gap between adult and pediatric ALL."

Retrospective data • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Immunotherapy without or with low-intensity chemotherapy versus standard chemotherapy as first-line treatment for newly diagnosed b-ALL patients: A propensity score-matched study (ASH 2025) - "Among them, 25 patients received immunotherapy(blinatumomab or inotuzumab ozogamicin) without or with low-intensity chemotherapy (immunotherapy group) while 108 patients received standard chemotherapy(chemotherapy group). Our present study demonstrates that immunotherapy without or with low-intensity chemotherapy as first-line treatment improves clinical efficacy while reducing adverse events in newly diagnosed B-ALL patients compared to standard chemotherapy."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Respiratory Diseases • Solid Tumor

T-cell engaging bispecific antibody shows potent MRD negativity with variable remission and survival outcomes: A bayesian meta-analysis of randomized controlled trials (ASH 2025) - "While CR and OS benefits show promise, particularly in frontline settings, heterogeneity underscores the influence of disease stage on outcomes. Clinically, these findings support integrating blinatumomab into standard regimens for R/R and MRD+ patients to enhance deep responses and potentially reduce relapse, urging further trials in pediatric and high-risk cohorts to refine its role in transforming B-ALL care."

Minimal residual disease • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Blinatumomab vs. chemotherapy in pediatrics B-cell ALL: A meta-analysis of randomized controlled trials (ASH 2025) - "This meta-analysis supports adding Blinatumomab to chemotherapy for improved survival in pediatric relapsed/refractory B-ALL. Its focus on pediatric RCTs enhances relevance, but variability in MRD response and adverse event reporting limits conclusions on safety. Standardized MRD and toxicity assessments are needed."

Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Pediatrics

Favorable survival and tolerability of the GMALL protocol in adolescents and young adults with ALL: A single-center experience (ASH 2025) - "In general, pediatric and pediatric-inspired regimens involve high cumulative doses of vincristine, glucocorticoids, and asparaginase (ASP), with most regimens adding an anthracycline (usually doxorubicin or daunorubicin), along with intensive and prolonged central nervous system prophylaxis...Four patients (10%) were CD20 positive, and three of them received rituximab (3-7 doses in total). Five received blinatumomab prior to transplant for MRD eradication, and 16 underwent allogeneic transplantation in first complete remission (CR1)... Our single-center experience in AYA-ALL patients aged 18–40 treated with the pediatric- inspired GMALL protocol demonstrates favorable survival outcomes and good tolerability. These real-world findings align with previously reported GMALL clinical trial data and are comparable to outcomes seen with more intensive pediatric regimens in this age group."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Pancreatitis • CD20

Front-line treatment of Philadelphia negative B-cell acute lymphoblastic leukemia with hypercvad with blinatumomab (ASH 2025) - "The MD Anderson Cancer Center (MDACC) also has published a regimen incorporating Blin into hyperCVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) therapy as induction and consolidation for adults with Ph neg B-ALL...Two doses of rituximab were included in each of the first 4 cycles of therapy when CD20 expression was identified on ≥20% of blasts at diagnosis. Intrathecal prophylaxis consisted of alternating doses of methotrexate and cytarabine, with a goal of administering 2 doses per cycle for a minimum of 8 doses... The addition of Blin to front-line hyperCVAD chemotherapy is associated with excellent RFS in adults with standard-risk ALL, but patients with HR genotypes remain at risk of relapse within one year of treatment initiation. This demonstrates a need for further iteration on this approach to better mitigate the risk of relapse. Because alloHCT remains the best approach to sustain long-term definitive disease control, it remains especially..."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • CD20 • CRLF2 • JAK2 • KMT2A • TP53

Efficacy and safety of blinatumomab as frontline treatment for infant acute lymphoblastic leukemia (ASH 2025) - "Among the high-risk patients (n=8), 5 pts received concomitant venetoclax (BCL2 inhibitor) during their first blinatumomab cycle. It is expected that new immunotherapeutic agents will change the treatment predicament of childhood ALL, especially infant ALL. However, large-scale clinical data and longer follow-up are still needed for verification."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • KMT2A • PAX5

Fc engineering of CD9 antibodies overcomes platelet toxicity and preserves superior potency against refractory acute lymphoblastic leukemia (ASH 2025) - "Notably, single-agent N297A-engineered hAbs treatment profoundly reduced multi-organ leukemia burden by >98% ( P <0.01) and introduced clear survival benefits (53-62 days vs. 27 days, P =0.003) in PDXs developed from ALL patients who relapsed from CAR T or blinatumomab therapies displaying CD19 antigen loss...This study potentially breaks the bottleneck of CD9-targeted therapy development and puts forward a new agent for refractory ALL patients failing upfront immunotherapies. Further validations in large animal models are ongoing."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Thrombocytopenia • CD22 • CD4 • CD9 • IFNG • SELP

Increased dosing of blinatumomab in children and adolescents with Relapsed/Refractory B-lineage acute lymphoblastic leukemia – beneficial safety profile with 30µg/m²/day in a single center study (ASH 2025) - "Escalating the blinatumomab dose to 30μg/m²/day in pediatric B-ALL appears safe and did not increase toxicity or CRS severity relative to the standard dose. Even in children with high-risk or refractory disease, high-dose blinatumomab produced MRD responses similar to standard dosing. Changing pediatric standard dosing in the future will require prospective controlled clinical trials."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia

Second-generation tyrosine kinase inhibitors vs imatinib in adult ph+ ALL: Target-trial emulation using a propensity-matched multinational cohort (ASH 2025) - "Second-generation BCR-ABL1 tyrosine-kinase inhibitors (2G-TKIs; dasatinib, nilotinib, bosutinib) achieve deeper kinase inhibition and superior central-nervous-system penetration, yet their incremental benefit over imatinib in modern adult practice remains uncertain because head-to-head phase-3 trials are lacking. Frontline second-generation BCR-ABL1 TKIs, predominantly dasatinib, deliver a clinically meaningful five-year survival advantage over imatinib in real-world adult Ph+ ALL without increasing treatment-related mortality. The benefit is concentrated in adults older than 35 years, whereas estimates in 18–35 years are not significant, supporting age-informed TKI selection. Transplant use and CNS relapse are similar between groups, and falsification outcomes are neutral, strengthening causal confidence."

Clinical • Acute Lymphocytic Leukemia • Diabetes • Gastroenterology • Gout • Hematological Disorders • Hematological Malignancies • Inflammatory Arthritis • Leukemia • Nephrology • Renal Calculi • Rheumatology • Thrombocytopenia • ABL1 • BCR

A-319, a CD3xCD19 T cell engager, monotherapy for patients with refractory/relapsed B-cell acute lymphoblastic leukemia (r/r B-ALL) (ASH 2025) - "Introduction Blinatumomab has been approved to treat patients with B cell precursor acute lymphoblastic leukemia (B-ALL) with 28-day continuous IV infusion. Conclusions When administered at 3-day (D1, D3, D5) dosing with 4-day (D2, D4, D6-D7) pause schedule, A-319 (1.2μg/kg/day) demonstrated a tolerable safety profile with a high CR and MRD- rate in r/r B-ALL patients, especially for those patients with high tumor burden. Therefore, further clinical study is warranted."

Clinical • Monotherapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia

Identification of TPR::FGFR1 fusion in an unusual case of concurrent acute B lymphoblastic leukemia and T-lymphoblastic lymphoma: Case report and review of literature (ASH 2025) - "Bone marrow biopsy after 1 cycle of Blinatumumab showed 11% myeloblasts concerning for therapy related myelodysplastic syndrome with excessive blasts, so he was started on azacitadine and venetoclax. His WBC count and blasts continued to rise despite treatment and repeat bone marrow biopsy showed a new TPR:FGFR1 rearrangement in addition to MECOM:MNBL1 fusion, so he was transitioned to Pemigatinib with plan to proceed with allogenic stem cell transplant. He received FLAG-Ida-Ven followed by bone marrow transplant but passed away approximately two months later due to disease progression.We describe and review literature on the first case of TPR:FGFR1 fusion arising post-cytotoxic therapy in a composite nodal T-LBL and bone marrow B-ALL."

Case report • Clinical • Review • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Eosinophilia • Hematological Malignancies • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Myelodysplastic Syndrome • CD1a • FGFR1 • MECOM • MME • PAX5 • RUNX1 • SH2B3

Bi-allelic germline SH2B3 loss in pediatric B-ALL with cirrhosis and autoimmunity (ASH 2025) - "Salvage reinduction followed by three cycles of blinatumomab resulted in CR2; hematopoietic stem cell transplantation (HSCT) is planned but deferred due to advanced liver disease...Given that our patient is not fit for HSCT, ruxolitinib was initiated in addition to maintenance chemotherapy with no excess toxicity...This case further elucidates the role of SH2B3 in leukemogenesis and supports for screening of SH2B3 variants in patients with ALL and gain of RUNX1. Future research is necessary to identify the optimal treatments for this condition, including the potential use of JAK inhibitors."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Celiac Disease • Chronic Myelomonocytic Leukemia • Endocrine Disorders • Fibrosis • Gastroenterology • Hematological Malignancies • Hepatology • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Juvenile Myelomonocytic Leukemia • Leukemia • Liver Cirrhosis • Pediatrics • Portal Hypertension • Rheumatoid Arthritis • Rheumatology • ABL1 • BCR • CDKN2A • RUNX1 • SH2B3