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

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

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

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

Defining the role of blinatumomab in frontline B-ALL: lessons from E1910 (EHA 2025) - "Sponsored by Amgen"

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

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

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

SAFETY AND EFFICACY OF SINGLE-AGENT SUBCUTANEOUS BLINATUMOMAB IN ADULTS WITH RELAPSED/REFRACTORY (R/R) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL): RESULTS FROM A PHASE 1/2 DOSE EXPANSION STUDY (EHA 2025) - P1/2 | "In this large cohort of 88 pts with R/R B-ALL, single agent SC blinatumomab, resulted in high efficacy, with high MRD-negativity rate and acceptable safety profile. The trial is ongoing and will continue to assess efficacy and AE management in phase 2."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Inflammation • Leukemia • Oncology

EFFICACY AND SAFETY OUTCOMES OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) STRATIFIED BY AGE IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) (EHA 2025) - P1/2 | "A higher proportion of pts aged <55 years were Hispanic/Latino (36.7% vs 18.8%), had extramedullary disease at lymphodepletion (29.1% vs 8.3%), and had received prior blinatumomab (53.2% vs 22.9%), and/or prior inotuzumab ozogamicin (35.4% vs 25.0%) vs those aged ≥55 years... Obe-cel treatment was associated with deep and durable remissions resulting in favorable ORR, EFS, and OS with low incidence of Grade ≥3 CRS and ICANS in both age groups. These findings indicate that obe-cel is effective and has a positive benefit and risk profile regardless of pt age, including in older adults with R/R B-ALL, despite few pts receiving consolidative SCT"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic 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

HEALTH-RELATED QUALITY OF LIFE BENEFITS OF FRONTLINE PONATINIB PLUS BLINATUMOMAB IN ADULT PATIENTS WITH PH+ ACUTE LYMPHOBLASTIC LEUKEMIA. PRELIMINARY ANALYSIS OF THE GIMEMA ALL2820 TRIAL (EHA 2025) - "We report the first evidence-based data on HRQoL of adult patients with newly diagnosed Ph+ ALL treated in induction/consolidation with ponatinib plus blinatumomab. Our findings indicate notable HRQoL improvements across all age groups, although younger patients seem to benefit the most from this novel treatment approach, devoid of systemic chemotherapy. Further analyses will elucidate on the value of this approach compared with standard of care."

Clinical • HEOR • Acute Lymphocytic Leukemia • Fatigue • Hematological Malignancies • Leukemia • Oncology • Pain • Pulmonary Disease

DEVELOPMENT OF AN IN VITRO BIOMARKER PLATFORM FOR DETERMINING BISPECIFIC ANTIBODY EFFICACY IN HAEMATOLOGICAL MALIGNANCIES (EHA 2025) - "T cell-to-target synapse formation was initially measured by co-incubation of purified T cells from healthy donors (HD) with one of a range of CD19+CD20+ tumour cell lines (Raji, Mino, JeKo-1) at a ratio of 1:1 in the presence of one of the bispecific antibodies (blinatumomab, epcoritamab or glofitamab (10 ng/ml)) for 1 hour at 37°C. The whole PBMC synapse-formation assay provides an accessible real-world assessment of synapse formation in patient blood samples prior to commencing bispecific antibody treatment. This new in vitro platform may be used as a biomarker for bispecific antibody efficacy. This study has important implications for bispecific antibody dosing in applications where T:B cell ratios are highly skewed."

Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20 • CD4 • CD8

EFFICACY AND SAFETY OF REGIMEN WITH OLVEREMBATINIB AND BLINATUMOMAB FOR THE FRONTLINE TREATMENT OF PH-POSITIVE OR PH-LIKE ACUTE LYMPHOBLASTIC LEUKEMIA (EHA 2025) - "This study presents the first clinical experience with the combination of olverembatinib and blinatumomab as a chemotherapy-free treatment regimen for patients with Ph-positive or ABL-class Ph-like ALL. The findings demonstrate excellent efficacy, rapid achievement of CMR, and an optimal safety profile, with no dose interruptions or cardiovascular toxicities observed. These results strongly suggest that this regimen represents a promising chemotherapy-free treatment option for patients with Ph-positive ALL."

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

REAL-WORLD OUTCOMES OF ADULT B-ALL PATIENTS WHO EXPERIENCE RELAPSED OR REFRACTORY DISEASE FOLLOWING BREXUCABTAGENE AUTOLEUCEL, A STUDY BY THE ROCCA CONSORTIUM (EHA 2025) - "However, CR2 for specific therapies included subsequent CAR-T (100%), TKI monotherapy (64%), inotuzumab-containing regimen (53%), salvage chemotherapy (32%), blinatumomab-containing regimens (33%), or BCL2-inhibitor-containing regimens (22%). Outcomes of refractory B-ALL following commercial brexu-cel are poor with a median OS of 3 months underscoring a need for novel salvage therapies following bexu-cel failure. In contrast, patients who relapsed >6 months have an encouraging 1-year OS of 67%. Salvage treatment decisions should be personalized considering patient and disease specific factors."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology

COMPARATIVE EFFICACY OF THE GIMEMA LAL1913 STANDARD CHEMOTHERAPY PROTOCOL VERSUS THE STANDARD ARM OF THE E1910 TRIAL IN MRD-NEGATIVE PH-NEGATIVE ALL: A MAIC ANALYSIS (EHA 2025) - "In the E1910 trial (Litzow et al, NEJM 2024), Ph- B-ALL patients MRD- after induction treatment were randomized to receive as consolidation standard of care chemotherapy (SOC) or SOC plus blinatumomab. The GIMEMA LAL1913 chemotherapy regimen offers outcomes comparable to those of the E1910 trial's standard arm in MRD- Ph- B-ALL, supporting the clinical equivalence of the Italian standard approach. These findings also provide indirect evidence of the superiority of blinatumomab and to advocate for the adoption of blinatumomab-based consolidation, to further improve outcomes also in MRD- Ph- B-ALL patients."

Clinical • Minimal residual disease • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

MRD-BASED TARGET THERAPY FOR PH-NEGATIVE ACUTE LYMPHOBLASTIC LEUKEMIA IN ADULT PATIENTS BY THE RALL-2016M PROTOCOL: EFFECTIVE FOR BCP-ALL, SHOWS NO EFFICACY IN T-ALL (EHA 2025) - P=N/A | "The RALL-2016m study demonstrates the high effectiveness of therapy aimed at rapid reduction of the residual tumor clone. The results show efficacy and an acceptable toxicity profile. Consolidation with blinatumomab for B-ALL with MRD persistence significantly improved the results and equalized the chances of patients with the group without persistent MRD."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

DISCOVERY OF A NOVEL BCP-ALL MOLECULAR SUBGROUP DEFINED BY IGH::FENDRR GENE FUSION, FOXF1 OVEREXPRESSION AND KRAS A146 MUTATION (EHA 2025) - "Of these, six remained MRD positive following Induction/early consolidation therapy and five reached MRD negativity only after Blinatumomab treatment or allogenic stem cell transplantation, indicating an inferior response to chemotherapy... IGH::FENDRR gene fusion, FOXF1 overexpression and a KRAS p.A146 mutation define a novel BCP-ALL subgroup. Current data indicate an unfavorable initial response to therapy. A distinct overexpression of VEGFR2 in this group suggests a potential for subgroup-specific therapy options."

Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • ABL1 • KDR • KRAS

OUTCOMES OF BLINATUMOMAB ADDED TO CONDITIONING REGIMEN OF ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR ADULT B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA PATIENT WITH LOW MINIMAL RESIDUAL DISEASE (EHA 2025) - "Patients received 7-14 days of blinatumomab ( 8 μg/d) followed by myeloablative conditioning (cytarabine busulfan cyclophosphamide MECCNU ATG). Short-course blinatumomab conditioning in B-ALL patients with low MRD or persistent fusion genes reduces post-transplant relapse risk and improves long-term survival suggesting its potential as a safe and cost-effective strategy in allo-HSCT regimens."

Clinical • Minimal residual disease • Residual disease • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Leukemia • Oncology • Transplantation • PBX1

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

LOWER-INTENSITY CHEMO-IMMUNOTHERAPY WITH CLADRIBINE, LOW-DOSE CYTARABINE, VENETOCLAX AND BLINATUMOMAB PRODUCES HIGH RESPONSE RATES IN PATIENTS WITH BCR::ABL1-NEGATIVE B/MYELOID MIXED PHENOTYPE ACUTE LEUKEMIA (MPAL) (EHA 2025) - "VEN (400 mg daily or an equivalent dose) was given for 5 to 14 days and dexamethasone was given for 4 days in each cycle...2 pts were previously treated: 1 pt received a cycle of CLAD, LDAC, VEN, and vincristine without blinatumomab and had only a partial response; the 2nd pt was initially treated with one cycle of IV decitabine and VEN, with residual disease... A combination of CLAD, LDAC, VEN, and blinatumomab shows early promise as a lower-intensity hybrid therapy for BCR::ABL1-negative B/myeloid MPAL, with high rates of MRD negative CR, manageable side effects and no early therapy-related mortality."

Clinical • Febrile Neutropenia • Ovarian Cancer • Solid Tumor • ABL1 • KMT2A

INDIVIDUALIZED AND INCLUSIVE STRATEGIES FOR TREATING JEHOVAH'S WITNESSES WITH ACUTE LEUKEMIA AND HIGH-GRADE MYELOID NEOPLASMS (EHA 2025) - "Treatments included: 7+3, attenuated decitabine+venetoclax, and azacitidine and sorafenib...One, treated with dasatinib+HyperCVAD, relapsed after 9 mos, then received Ponatinib+Blinatumomab, and underwent stem cell transplant...The third pt was treated with cyclophosphamide/topotecan for a co-occurring neuroblastoma without response, switching to blinatumomab then hospice due to neuroblastoma progression.For MDS - 1 pt received luspatercept for 8 mos before cessation due to cytopenia (Hgb of 2.9 g/dL)...TPO agonists included romiplostim at 2 to 4 mcg/kg weekly or daily eltrombopag, while G-CSF (Filgrastim, 5 mcg/kg) was administered based on ANC levels. Our study of Jehovah's Witness pts with acute leukemia and high-grade MDS underscores the possibility of individualized leukemia-directed care despite transfusion limitations. Despite significant baseline cytopenias, individualized treatment approaches and the use of hematopoietic growth factors can facilitate the..."

Clinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Myelofibrosis • Neuroblastoma • Oncology • Septic Shock • Solid Tumor • NPM1

EFFICACY AND SAFETY OF BLINATUMOMAB IN NEWLY-DIAGNOSED PATIENTS WITH PH-POSITIVE/NEGATIVE B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (EHA 2025) - "All patients were treated with a course of 14-day or 28-day blinatumomab therapy with Ph+ patients receiving Dasatinib or Olverembatinib (third-generation tyrosine kinase inhibitor) throughout the treatment. The study demonstrates that compared with traditional induction chemotherapy, blinatumomab has showed favorable efficacy and safety in patients with Ph+/- status and high-risk genetic features. However, the relationship between blinatumomab and CNS relapse warrants further investigation."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • IKZF1 • PAX5 • TP53

TYROSINE KINASE INHIBITORS WITH BLINATUMOMAB VERSUS CHEMOTHERAPY IN PHILADELPHIA-POSITIVE ACUTE B-LYMPHOBLASTIC LEUKEMIA (EHA 2025) - "Our findings, consistent with published prospective trials, highlight the safety and efficacy of TKI and blinatumomab in managing Ph+ B-ALL."

Hematological Malignancies • Leukemia • Oncology

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

FIRST-LINE (1L) AND SECOND-LINE (2L) TREATMENT PATTERNS IN PATIENTS WITH B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN DIFFERENT TIME PERIODS (EHA 2025) - "The proportion of patients receiving blinatumomab-containing regimens (blin) increased from 9% to 25% over the two time periods...The use of inotuzumab-containing regimens (ino) was low in both periods (2014-2020, 2%; 2021-2024, 11%), reflecting its lack of approval in 1L B-ALL... The 1L and 2L treatment landscape in B-ALL has evolved following the approvals of targeted therapies. Although MDT regimens continue to form the backbone of therapy in B-ALL, targeted therapies are increasingly used in earlier treatment lines. Further follow-up is needed to assess the impact of earlier use of targeted immunotherapy on overall survival and progression-free survival."

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

INOTUZUMAB OZOGAMICIN FOR THE TREATMENT OF B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN PEDIATRIC AND ADOLESCENT PATIENTS (EHA 2025) - "All received a 5-day pre-conditioning regimen (VAD, Vindesine 3mg/m2 on D1; Cytarabine, 100mg/m2 on D1-5; and dexamethasone 6mg/m2 on D1-5 (for intolerant patients, it can be replaced with methylprednisolone, 1.5-2mg/kg)...Treatment status was different: 4 cases with R/R B-ALL (received sequential Blinatumomab therapy 6 months post-InO treatment), 23 patients in the remission induction phase(14 with MRD > 0.1%, 3 adolescents and young adults (AYA) B-ALL, 3 of high-risk B-ALL, and 3 intolerant to chemotherapy, 8 cases with persistent MRD+ after the induction remission phase and 10 was the maintenance phase... All 39 pediatric patients achieved MRD negativity after one treatment cycle of InO and none developed veno-occlusive disease (VOD). Thus, we recommend expanding the use of InO in newly diagnosed pediatric and AYA patients with high-risk, Ph+, and chemotherapy-intolerant B-ALL."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • Pediatrics • Thrombocytopenia • CD22 • CRLF2 • CSF1R • FLT3 • IKZF1 • PBX1 • SSBP2 • TP53