Besponsa (inotuzumab ozogamicin) / Pfizer - 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

Inotuzumab ozogamicin as salvage therapy for refractory/relapsed B-cell acute lymphoblastic leukemia following the failure of chimeric antigen receptor T cell therapy and allogeneic hematopoietic stem cell transplantation (ASH 2025) - "However, two out of them relapsed 8 and 9.5 months after the InO initiation, respectively. In conclusion, InO is a well-tolerated, effective regimen for patients with B-ALL who relapse after prior CAR-T therapy and allo-HSCT, despite the long-term progression free survival needs improving."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Hepatology • Leukemia • Transplantation • CD22

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

Successful treatment of two refractory acute lymphoblastic leukemia cases with an orelabrutinib-based regimen (ASH 2025) - "Treatment with the CD22 monoclonal antibody (Inotuzumab ozogamicin) reached a CRi (complete remission with incomplete hematologic recovery), but relapse occurred one month later...Subsequently, blinatumomab was administered to eradicate MRD, followed by a matched sibling allogeneic hematopoietic stem cell transplant...Due to financial constraints, she was unable to receive immunotherapy and was instead treated with orelabrutinib combined with venetoclax and chidamide...Conclusion The successful treatment of these two cases demonstrates the potential of orelabrutinib in refractory or primary resistant B-ALL patients, offering a novel therapeutic option for this high-risk population. This study supports further exploration of orelabrutinib-containing regimens in the clinical management of B-ALL."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • CD22 • IKZF1 • PBX1 • SETD2

Outcomes of concomitant Philadelphia chromosome-positive and CRLF2-rearranged B-cell ALL (ASH 2025) - "All newly diagnosed pts (n=6) received ABL1 kinase TKI-based induction (ponatinib, n=4; dasatinib, n=1; imatinib, n=1) with hyper-CVAD (n=3), pediatric-inspired regimens (n=2), and blinatumomab-ponatinib (n=1)...However, 2-years later, patient developed flow MRD+ disease and received inotuzumab + ponatinib followed by allo-SCT and died 2-months later from post-transplant complications...Both patients also had ruxolitinib added to the salvage treatment. Concomitant Ph+/CRLF2+ B-ALL represents a rare but high-risk subset with inferior outcomes despite TKI- and immunotherapy-based regimens. Notably, relapses often involved loss of the Ph+ clone with persistence of CRLF2+ disease."

IO biomarker • Acute Lymphocytic Leukemia • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Leukemia • ABL1 • CRLF2 • IKZF1 • JAK2 • NRAS • PTPN11

A real world study of inotuzumab ozogamicin for the treatment of B-cell acute lymphoblastic leukemia: Multi-center result from SH-ALL group (ASH 2025) - "Among 70 Ph neg pts, 21 pts received INO+venetoclax (VEN). From June 2022 to July 2025, a total of 102 pts with B-ALL received INO-based therapy in 8 centers in Shanghai, among whom 93 pts with available data were analyzed. The median age was 57 years old (range, 17-77). There were 23 (24.7%) Ph pos pts and 70(75.3%) Ph negative (Ph neg ) pts."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hepatology • Thrombocytopenia • CD22 • TP53

Role of DNA damage sensing and TP53 function as modulators of sensitivity to calicheamicin-based antibody-drug conjugates (ADCs) for acute leukemia (ASH 2025) - "Better survival of some patients with the CD33 ADC, gemtuzumab ozogamicin (GO), and the CD22 ADC, inotuzumab ozogamicin (InO), validate these efforts, but these ADCs are ineffective in many others...CLM-induced cytotoxicity was assessed in vitro in the presence/absence of a Mouse Double Minute 2 homolog (MDM2) inhibitor (idasanutlin), Ataxia-Telangiectasia Mutated (ATM) inhibitor (AZD1390, lartesertib), Ataxia Telangiectasia and Rad3-related (ATR) inhibitor (ceralasertib), Checkpoint Kinase 1 and Checkpoint Kinase 1 (Chk1/Chk2) inhibitors (prexasertib, BML-277), and poly(ADP-ribose) polymerase (PARP) inhibitor (veliparib)... Our studies identify ATM, MDM2, and TP53 as key modulators of CLM-induced cytotoxicity in acute leukemia cells. These results support further evaluation of combination therapies with corresponding small molecule inhibitors (currently pursued in patients with other cancers) toward possible clinical testing as novel strategies to increase the efficacy..."

Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Ataxia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immunology • Leukemia • Movement Disorders • Primary Immunodeficiency • CD22 • CD33 • CDKN1A • FBXW7 • TP53

First report of the GIMEMA INO-first multicenter observational study analyzing infective and non-infective complications in patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with inotuzumab ozogamicin. (ASH 2025) - P | "These AEs occurred in only 8.2% ofpatients and resulted in treatment discontinuation in only 2.8% of cases. These findings support the useof INO as a suitable bridging therapy to SCT or to other cellular immunotherapies."

Clinical • Observational data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Mucositis • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Stomatitis • CD22

Transplant outcomes of b acute lymphoblastic leukemia treated with inotuzumab ozogamicin with mini–Hyper-CVD based chemo-immunotherapy (ASH 2025) - "The chemotherapy protocol consisted of mini-CVD part A(cyclophosphamide at 150mg/m2 x 4 doses, dexamethasone 20mg x 4 days, vincristine 1.5mg on day 1and 8, but no anthracycline) or part B (methotrexate 250mg/m2 and cytarabine 0.5gm/m2 x 4 doses)...CD22 expression was positive in 22patients (91.4%), Other therapies added to this regimen included tyrosine kinase inhibitors in 3 patients(12.5%), venetoclax in 13 patients (54%), and rituximab in 11 patients (45.3%).The overall response rate (ORR) was 95.8% (n = 23)...Conditioning regimens included Flu/TBI in 12 patients, Fludarabine(Flu)/Melphalan (Mel) in 2 patients, Flu/Mel/Total Body Irradiation (TBI) in 4 patients,Flu/Cyclophosphamide/TBI in 2 and Flu/Thiotepa/TBI in 1. Graft versus host disease prophylaxis varied,with post-transplant cyclophosphamide (PTCy) /Cyclosporine (CsA)/mycophenolate mofetil (MMF) used in15 patients, PTCy/CSA in 5, and CSA/methotrexate in 1...InO mini CVD is a feasible and effective salvage..."

IO biomarker • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Leukemia • Neutropenia • Septic Shock • Transplantation • CD20 • CD22 • CD34 • TP53

CRLF2-rearrangement and extramedullary disease in B-cell acute lymphoblastic leukemia: A possible link? (ASH 2025) - P1, P1/2 | "Notably, after blinatumomab and/or inotuzumab (administered for marrow relapse), five (23.8%)patients with CRLF2r B-ALL relapsed with EMD. Based on our analysis, we identified that patients with CRLF2r had higher rate of EMDcompared to those without CRLF2. While limited by factors inherent to retrospective analyses, ourfindings nonetheless suggest a potential association among CRLF2r and EMD that warrants further study.This is particularly imperative as this relationship may impact treatment approaches and guide decisionmaking. Additionally, in raising awareness about the presence of non-CNS EMD in B-ALL patients,establishing systematic approaches to assess for non-CNS EMD in high-risk patients is warranted."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • CDKN2A • CDKN2B • CRLF2 • IDH1 • JAK1 • JAK2 • KMT2D • KRAS • NRAS • PTPN11 • STAT3

Real-world treatment patterns, outcomes, and unmet needs in patients with ph+ ALL receiving tyrosine kinase inhibitors in the United States: Emerging trends and the role of asciminib-based combinations (ASH 2025) - "Anytime during the follow-up period, 67%received dasatinib, 35% ponatinib, 24% imatinib, 13% nilotinib, 6% bosutinib, and 66 (2%) asciminib-based therapy.Based on the index TKI, treatment patterns evolved over time, with important shifts between 2016 and2024...Asciminib was given ascombination therapy (82%) with corticosteroids (76%), chemotherapy (64%), inotuzumab ozogamicin(16%), and blinatumomab (15%). This real-world study described evolving patterns in the management of pts with Ph+ ALL... This real-world study described evolving patterns in the management of pts with Ph+ ALL. Inrecent years, increased use of ponatinib and immunotherapy has been observed alongside a decline inuse of dasatinib and imatinib. Despite therapeutic advances, many pts experienced clinical eventsassociated with TKI-related conditions, and one-third had disease relapse."

Clinical • HEOR • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Ischemic stroke • Leukemia • Myocardial Infarction • Respiratory Diseases

Time toxicity in ALL: Quantifying home days among adults with acute lymphoblastic leukemia (ASH 2025) - "A total of 354 patients were screened. After removing patients due to incomplete records, 136patients (72 Philadelphia chromosome [Ph] negative [-neg], 57 Ph+, 7 T-ALL) were included in the finaldataset. The mean age was 55 (range 18 – 93); 59% were male, 41% female; 63% were white, 16% wereBlack, 21% were other; 16% were Hispanic."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • T Acute Lymphoblastic Leukemia

Survival after first relapse of pediatric B-ALL differs by insurance type: A real-world analysis from the recall-1 study (ASH 2025) - "Use ofblinatumomab trended higher in those with private insurance (36% vs 45%, p=0.07), and inotuzumab wassimilar (11% for both, p=0.87)...In contrast, rates of MRD-negative CR2 and receiptof CAR-T and HCT were comparable across insurance types. These findings highlight the urgent need toidentify effective interventions that will ensure equitable outcomes after relapse."

Clinical • Real-world • Real-world evidence • Reimbursement • US reimbursement • Hematological Malignancies • Leukemia • Pediatrics

Donor-derived CAR-T cells co-infused with the allogenic graft on the platform of T cell depletion or post-transplant cyclophosphamide in children with advanced B-cell neoplasms (ASH 2025) - "All patients had disease relapse after multiple lines of treatmentincluding previous HSCT(n=13), blinatumomab (n=22), inotuzumab (n=2), blinatumomab+inotuzumab(n=6) and CAR-T cell infusion(n=12)...The median proportion ofCD19-positive cells in the leukemic population was 100% (0–100%), while the median proportion of CD22-positive cells was 100% (36–100%).Fourteen (36%) pts received treosulfan-based myeloablative preparative regimen and TBI-based regimenwas used in 25 (64%) pts...Inthe PtCy group GVHD prophylaxis included abatacept, vedolizumab and CsA or baricitinib ResultsThere was no suspected conflict between the graft and CAR-T cells...We have documented CAR-T expansion and persistence. Prospective testing of theapproach is warranted."

CAR T-Cell Therapy • Clinical • Metastases • Post-transplantation • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation • CD22

Long-term outcomes of a chemotherapy-free regimen of concomitant blinatumomab and inotuzumab ozogamicin in older patients with Philadelphia negative B-cell acute lymphoblastic leukemia (ASH 2025) - "Pts received the following treatment during cycle 1: dexamethasone 20 mgintravenously (IV) days 1-4, vincristine 1 mg IV day 4, fractionated InO 0.6 IV mg/m2 day 1 and 0.3 IVmg/m2 day 8 followed by blina IV days 15-28 (9 ug/day x 2 days followed by 28 ug/daily) followed by 2-week rest...Pts with CD20 positive ALL could receive rituximab 375 mg/m2 IV on days 2 and 9during cycles 1-4. Pts received 12 doses of intrathecal chemotherapy and ursodiol...There were no episodes of veno-occlusive disease.ConclusionA largely chemotherapy-free regimen of blina in combination with InO for older or unfit pts was toleratedand resulted in high rates of MRD-negative remission with 2-year survival rates of 50%. Most deaths areattributable to non-relapse mortality, suggesting that continued optimization of treatment regimens areneeded for older pts with B-cell ALL."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Leukemia • Leukopenia • Myocardial Infarction • Neutropenia • Respiratory Diseases • Thrombocytopenia • CD20 • CRLF2 • KMT2A

Efficacy and safety of a retreatment with inotuzumab ozogamicin in adult patients with relapsed/refractory acute lymphoblastic leukemia: A Campus ALL study (ASH 2025) - "Notably, the incidence of thesetoxicities was not significantly higher than those reported during the first Ino exposure.ConclusionsThis study indicates that retreatment with Ino is a valuable option associated with a high CR rate andacceptable safety, even in heavily pretreated relapsed patients. Notably, the clinical outcomes forpatients who responded to Ino retreatment and were subsequently bridged to CAR-T therapy wereparticularly encouraging."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Hepatology • Leukemia

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 with extended follow-up (ASH 2025) - P1/2 | "At baseline, patients had received a median of 2 prior lines of therapy (range, 1–7),which included cIV blinatumomab in 17 (22%), chimeric antigen receptor T-cells in 14 (18%), HSCT in 23(29%), and inotuzumab ozogamicin in 26 (33%) patients. Consistent with prior findings, single-agent SC blinatumomab maintained durable remissionsand OS in this extended follow-up analysis. These outcomes were observed across the 250/500 and500/1000 doses and were independent of HSCT status. Compared to our previous report, this analysisincludes additional follow-up and updated post-HSCT outcomes."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Septic Shock

Phase 1 evaluation of the safety and efficacy of rapcabtagene autoleucel (YTB323) in adult patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (ASH 2025) - P1/2 | "Sixteen pts (46%) were previously treated with blinatumomaband 13 pts (37%) with inotuzumab...CRS management includedtocilizumab (70%), siltuximab (10%), corticosteroids (40%), tocilizumab plus corticosteroids (37%), andanakinra (7%)...Seven pts received supportive measures for ICANS,including dexamethasone (5 pts, 71%) and anakinra (3 pts, 43%)... Phase 1 results with long follow-up suggest rapcabtagene autoleucel is active with highcellular expansion, durable efficacy for DL2–DL4, and a manageable safety profile in adult pts with r/r B-ALL. DL3—at which 92% of pts achieved BOR of CR/CRi by 3 mo, with median DOR not reached after 22mo median follow-up—exhibited an acceptable balance of safety, efficacy, and cellular expansion."

Clinical • P1 data • Acute Lymphocytic Leukemia • Aplastic Anemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Neutropenia • Rare Diseases

Risk factors for relapse and post-relapse outcomes in patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia receiving frontline blinatumomab-based regimens (ASH 2025) - "Inotuzumab (Ino) was used frontlinein 173 pts (73%)...A total of 27 pts (96%) received at least one line of salvage therapy, with 2nd CRc attained in 18 pts (67%).1st salvage regimens included chemotherapy backbone (+/- venetoclax, Blina/Ino) in 24 pts (89%), CAR-Tin 2 pts, and Ino alone in 1 pt... Relapse after frontline Blina-based regimens in Ph-neg B-ALL is infrequent, with a 3-year CIRof 13% in our cohort. We identified older age, obesity, and baseline WBC>50k as key risk factors forrelapse. Post-relapse outcomes are dismal, with a median OS of only 8.6 mos (2-year OS 30%),underscoring the need for newer therapies."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Genetic Disorders • Hematological Malignancies • Leukemia • Obesity • CD19 • CRLF2 • KMT2A • TP53

Safety and efficacy of carniospinal irradiation (CSI) before CAR T cell therapy in patients with acute lymphoblastic leukemia (ALL) with central nervous system (CNS) disease: A potential role for CSI beyond cell killing and into immune priming (ASH 2025) - "Background : Outcomes of patients (pts) with B-cell acute lymphoblastic leukemia (B-ALL) have improvedsignificantly with the Introduction of targeted therapies such as blinatumomab, inotuzumab, and CD19-directed CAR T cell therapies... A total of 12 patients were identified who received CSI prior to CAR T cell infusion. The time fromthe completion of CSI to infusion of CAR T cells was a median of 20 days (range, 7-67). Eleven receivedBrexu-cel, and 1 received Obe-cel."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia

KMT2Ar, but not other high-risk genetics, adversely impacts outcomes in adult patients with relapsed/refractory (R/R) Philadelphia chromosome negative B-cell acute lymphoblastic leukemia (B-ALL) treated with brexucabtagene autoleucel (Brexu-cel) (ASH 2025) - "HR and SR pts had similar disease burden pre-apheresis (>5% blasts: 58% vs 53%), priorblinatumomab (60% vs 58%), prior inotuzumab (42% vs 46%), and prior allo HCT (27% vs 37%). To our knowledge, this analysis represents the largest examination of adult B-ALL recipients of CAR-Tassessed by genomic risk group. We found that response rates and survival outcomes following brexu-cel were similar among HR and SR B-ALL pts, including pts with TP53m and CRLF2r. However, pts withKMT2Ar had lower response rates and dismal EFS and OS, with higher rates of PD and myeloidtransformation at relapse, suggesting that alternative strategies are necessary to improve outcomes forpatients with R/R KMT2Ar B-ALL."

Adverse events • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • CRLF2 • IKZF1 • JAK2 • KMT2A • TP53

Safety and efficacy of low-intensity chemotherapy combined with sequential blinatumomab and inotuzumab ozogamicin immunotherapy in newly diagnosed B-ALL patients unfit/fit-declined for intensive chemotherapy: A prospective, open-label, single-arm Phase II trial in progress (ASH 2025) - P1/2, P2 | "The study will enroll 26 newly diagnosed B-ALL pts aged ≥60 yearsor 15-60 years, who are either unfit for intensive chemotherapy or fit but have declined it (fit-declined).Unfit pts must have Eastern Cooperative Oncology Group performance status ≥2 or at least one of: 1)congestive heart failure requiring therapy or left ventricular ejection fraction of ≤50%, 2) diffusingcapacity of carbon monoxide of ≤65% or forced expiratory volume in the first second of ≤65%, 3)creatinine >2×the upper limit of normal [ULN] or creatinine clearance 1.5×ULN or aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3×ULN), 5)active uncontrolled infection, 6), cognitive impairment, 7) other chemotherapy-contraindicatedcomorbidities.Induction therapy consists of low-intensity chemotherapy combined with BiTE with or without TKIs.Regimen included dexamethasone 8 mg/m²/day intravenously injection (IV), days 1-14, vindesine 4 mg, IV,day 7,..."

Clinical • P2 data • Acute Lymphocytic Leukemia • Alzheimer's Disease • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Cognitive Disorders • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Infectious Disease • Leukemia • CD22