Duoenda (mitoxantrone liposomal) / CSPC Pharma - LARVOL DELTA

Prognostic utility of myocardial work indices and biomarkers for identifying anthraquinone induced cardiotoxicity in hematopoietic stem cell transplantation (ASH 2025) - P=N/A | "Liposomal mitoxantrone shows promising potential for auto-HSCT conditioning. Myocardial work indices and specific biomarkers GLS could be integrated into clinical protocols for early detection and intervention of cardiovascular complications during chemotherapy."

Biomarker • Atrial Fibrillation • Bone Marrow Transplantation • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Lymphoma • Transplantation

Efficacy and safety of mitoxantrone hydrochloride liposome combined with pegaspargase in the treatment of extranodal NK/T-cell lymphoma (ASH 2025) - "The regimen combining PLM60 with pegaspargase demonstrates high ORR and DCR in treating extranodal NK/T-cell lymphoma. Adverse events were primarily hematologic toxicities, which were manageable overall. The regimen exhibits a favorable safety profile, thereby providing a new effective treatment option for ENKTL patients."

Clinical • Epstein-Barr Virus Infections • Extranodal Natural Killer/T-cell Lymphoma • Gastrointestinal Disorder • Immunology • Infectious Disease • Leukopenia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Mitoxantrone liposome combined with EAC autologous transplant conditioning for the treatment of T/NK non-Hodgkin's lymphoma (ASH 2025) - " The study retrospectively analyzed the data of T/NK cell lymphoma patients who underwent autologous hematopoietic stem cell transplantation from January 2023 to December 2024 in Xinqiao Hospital of the Army Medical University, and the transplant pretreatment regimen was: intravenous infusion of mitoxantrone hydrochloride liposomal 24mg/m 2 on the 7th day before autologous stem cell reinfusion; Etoposide 150 mg/m 2 daily from day 6 to day 3 before reinfusion; Cytarabine 150 mg/m 2 2 times/day from day 6 to day 3 before reinfusion; Cyclophosphamide 1.0 g/m 2 daily from day 6 to day 3 before reinfusion. Mitoxantrone liposomes combined with EAC conditioning for transplantation of T/NK non-Hodgkin lymphoma are safe and effective, and well tolerated, and the implantation kinetics have not changed, but further follow-up and expanded sample size evaluation are needed."

Bone Marrow Transplantation • Extranodal Natural Killer/T-cell Lymphoma • Febrile Neutropenia • Lymphoma • Natural Killer/T-cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

A potential drug to overcome the venetoclax resistance challenge in AML: Mitoxantrone hydrochloride liposome (ASH 2025) - "The venetoclax combined with azacitidine regimen has greatly improved the prognosis of acute myeloid leukemia (AML). Our study suggests that the MAV regimen may serve as a potential salvage therapy for AML patients who have failed venetoclax-based treatment. A phase II clinical trial is currently underway to further validate the efficacy and safety of the MAV regimen."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • MCL1 • TOP2A

Combination of mitoxantrone hydrochloride liposome with CLAG regimen in patients with relapsed or refractory Acute Myeloid Leukemia: A prospective, single-arm study (ASH 2025) - P4 | "The CLAG ± M/I regimen [cladribine, cytarabine, granulocyte colony-stimulating factor (G-CSF) ± mitoxantrone or idarubicin] is a common utilized chemotherapy regimen. Lipo-MIT combined with CLAG regimen showed a promising efficacy and manageable safety in R/R AML. The favorable post-transplant survival suggests this regimen is effective to bridge R/R AML patients to HSCT. The trial is still ongoing."

Clinical • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Bone Marrow Transplantation • Colorectal Cancer • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Thrombocytopenia • ASXL1 • CEBPA • FLT3 • TP53 • U2AF1

Liposomal mitoxantrone demonstrates superiority to traditional mitoxantrone in the treatment of AML (ASH 2025) - "Furthermore, we aim to explore potential optimizable combination regimens, with the Lipo-MIT plus venetoclax and azacitidine (VA-Lipo-MIT) protocol serving as a case in point. The VAM regimen demonstrates superior efficacy in prolonging survival compared to the VA regimen in the venetoclax-resistant MLL-AF9 model. These results support Lipo-MIT as a promising strategy combining direct antileukemic effects and immune modulation."

Head-to-Head • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Immune Modulation • Immunology • Leukemia • CD4 • CD8 • HOXA9 • NUP98

Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with rituximab, gemcitabine, dexamethasone, and cisplatin (R-GDPM) in Relapsed/Refractory diffuse large B-cell lymphoma: A multicenter, single-arm study (ASH 2025) - "The combination of Lipo-MIT with R-GDP demonstrated encouraging efficacy and a manageable safetyprofile in patients with R/R DLBCL. Further studies with continued follow-up are warranted to assesssurvival outcomes."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Dual epigenetic modulation with obinutuzumab/liposomal mitoxantrone in refractory or Relapsed Diffuse large B-cell lymphoma patients post-salvage therapy: A phase II study (ASH 2025) - P2 | "We previously investigated the efficacy of CD-R-GemOx, a dual epigenetic agent-primed immunochemotherapy regimen, consisting of chidamide,decitabine, rituximab, gemcitabine, and oxaliplatin, in this high-risk population...This emphasizes thecritical need to optimize the dual epigenetic immunochemotherapy approach to enhance patientoutcomes while mitigating adverse effects.Aims: This study aims to evaluate the efficacy and safety of a modified dual epigenetic primingimmunochemotherapy regimen, termed CAGM, consisting of chidamide, azacitidine, obinutuzumab, andmitoxantrone liposome, in R/R DLBCL patients who had failed salvage therapy. This ongoing, prospective, multicenter, open-label phase II study (NCT05823701) enrolledpatients with R/R DLBCL who had failed salvage therapy... This study demonstrates the favorable efficacy and significantly lower hematologicaltoxicities of the CAGM regimen in R/R DLBCL patients, offering a promising therapeutic option for..."

Clinical • P2 data • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Diffuse Large B Cell Lymphoma • Heart Failure • Infectious Disease • Lymphoma • Mucositis • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases

Lipo-MIT-based bridging therapy enables effective CAR-T treatment in high-risk relapsed or refractory B-cell lymphoma (ASH 2025) - "Mitoxantrone Hydrochloride Liposome (Lipo-MIT), aliposomal anthracycline with enhanced accessibility to mass tumor, has shown promising clinical efficacyin hematological malignancies. Here, we evaluated the efficacy and safety of R/G/Z-MINE regimenincluding CD20 antibody, Lipo-MIT, ifosfamide and etoposide as BT prior to CAR-T in patients (pts) withaggressive, bulky, or rapidly progressive R/R B-cell lymphoma.We retrospectively enrolled pts with R/R B-cell lymphoma who received at least one cycle of R/G/Z-MINEregimen before CAR-T administration in a single institution from Feb 2022 to Aug 2024. Anti-CD20monoclonal antibodies were administered on day 0, including rituximab or zebrituzumab at 375 mg/m²or obinutuzumab at 1000 mg...In this pragmatic clinical study conducted in a cohort of pts with high tumor burden and rapidlyprogressive disease, R/G/Z-MINE regimen was shown to be a feasible bridging strategy that achievedeffective tumor debulking and controllable..."

B Cell Lymphoma • Burkitt Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma

Combination of mitoxantrone hydrochloride liposome with gemcitabine, cisplatin and dexamethasone (MGDP) in patients with relapsed or refractory peripheral T cell lymphoma: A prospective, single-arm, multicenter, Phase I/II study (ASH 2025) - P1/2 | "Lipo-MIT combined with GDP (MGDP) regimen demonstrated promising efficacy andmanageable safety in r/r PTCL, warranting further investigation."

Clinical • P1/2 data • Follicular Lymphoma • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • ALK

Mitoxantrone liposome plus cytarabine and azacitidine for newly diagnosed Acute Myeloid Leukemia: A prospective, multicenter, randomized controlled study (ASH 2025) - P3 | "daunorubicin or idarubicin, with the antimetabolitecytarabine—often known as the 7+3 regimen—which results in a complete remission (CR) rate of roughly60%. No treatment-related deaths were reported.Conclusion The MA+AZA regimen shows encouraging efficacy and manageable toxicity in newlydiagnosed AML. Preliminary efficacy was observed, with ongoing sample size expansion and follow-upextension to evaluate long-term survival outcomes"

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Thrombocytopenia • CD34

Liposomal mitoxantrone versus chidamide in relapsed/refractory peripheral T-cell lymphoma: Final analysis from the multicenter, prospective randomized phase 3 study (ASH 2025) - "Treatment discontinuations due to AEs were 15.8% vs 14.7%.ConclusionThe study met its primary efficacy endpoint. The outcome of the present phase 3 trial demonstrated thatthe efficacy of Lipo-MIT was superior to chidamide with an acceptable and manageable overall safetyprofile in patients with R/R PTCL."

Clinical • P3 data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Peripheral T-cell Lymphoma • Thrombocytopenia

A novel strategy to circumvent venetoclax resistance in relapsed/refractory Acute Myeloid Leukemia (ASH 2025) - P2 | "Mitoxantrone hydrochloride liposome (Lipo-MIT), a novelanthracycline nano-drug, has demonstrated improved pharmacokinetics and anti-leukemic activity. Wedeveloped the MAV regimen that includes Lipo-MIT, cytarabine and VEN for relapsed/refractory (R/R) AML(NCT06621212).This prospective study enrolled patients (≥18 years) with R/R AML and Eastern Cooperative OncologyGroup (ECOG) performance status 0-2... The MAV regimen demonstrates preliminary efficacy and manageable toxicity in R/R AML, showingparticular potential to overcome VEN resistance in relapsed patients with prior venetoclax exposure. Thisclinical trial remains ongoing."

Acute Myelogenous Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Chronic Myelomonocytic Leukemia • Febrile Neutropenia • Infectious Disease • Lymphoma • Myelodysplastic Syndrome • Neutropenia • Respiratory Diseases • Septic Shock • ASXL1 • RUNX1 • SRSF2 • STAG2

Venetoclax plus mitoxantrone hydrochloride liposome and Azacitidine As first-line treatment for adults with Acute Myeloid Leukemia (ASH 2025) - P4 | "Background The standard "3+7" regimen (idarubicin/daunorubicin combined with cytarabine, IA/DA) remains thecornerstone of first-line induction therapy for acute myeloid leukemia (AML), excluding acutepromyelocytic leukemia (APL). The adverse reactions weretolerated or controlled. Overall, the regimen was well tolerated in patients with AML at the initialdiagnosis.ConclusionAs a promising treatment, MVA regimen is effective and safe in newly diagnosed AML patients."

Clinical • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Nephrology • Neutropenia • Renal Disease • DNMT3A • FLT3 • RUNX1 • RUNX1T1

Mitoxantrone liposome, subcutaneous cytarabine and G-CSF (CMG) combined with venetoclax as first-line treatment in secondary Acute Myeloid Leukemia (sAML) or elderly AML patients: A multicenter, prospective, single-arm clinical trial with concurrent control (ASH 2025) - P=N/A | "CMG+VEN represents a more safe alternative regimen in sAML and elderly AML patients,showing higher MRD negative rate and deserving further investigation."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm

Single-center experience with mitoxantrone hydrochloride liposome-based therapy for patients with myeloid sarcoma (ASH 2025) - "Anotherpatient experienced a recurrence after consolidation treatment and died due to complicationsfollowing CAR-T and allo-HSCT therapy.Two patients with relapsed MS (with or without BM involvement) were treated with Lipo-MIT,cytarabine, and etoposide (MAE) ± PD-1...After one cycle of treatment with the VMCP (vindesine, Lipo-MIT, cyclophosphamide and dexamethasone) regimen, both BM and extramedullary sites wereassessed as CR, with negative minimal residual disease (MRD) detected by flow cytometry... Our results indicated the initial efficacy of Lipo-MIT for de novo MS, demonstrated by its ability to reduceor eliminate tumor burden within two cycles. Sequential allo-HSCT following remission could extendsurvival duration. Further large-sample analyses are anticipated to comprehensively elucidate theefficacy and safety of the Lipo-MIT-based regimen."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Pneumonia • Respiratory Diseases • Sarcoma • PD-1

Rituximab, cyclophosphamide, mitoxantrone hydrochloride liposome, vincristine, and prednisone (R-CMOP) in elderly patients with newly diagnosed diffuse large B-cell lymphoma: A multicenter, prospective study (ASH 2025) - P2 | "The R-CMOP regimen demonstrated encouraging efficacy and a manageable safety profile in patientsaged 60 years or older with newly diagnosed DLBCL. Further studies with continuation of follow-up arewarranted to confirm the clinical significance of the survival outcomes."

Clinical • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma

Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with azacitidine and Chidamide can be an effective chemotherapy regimen for patients with angioimmunoblastic T-cell lymphoma (AITL) (ASH 2025) - P4 | "Currently, cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is the mostcommon first-line chemotherapy regimen. This study showed that the Lipo-MIT combined with azacitidine and chidamide (MAC)regimen is associated with high response rate and manageable toxicity in patients with newly diagnosedand relapsed/refractory AITL. It deserves further large-sample studies to confirm efficacy and safety."

Clinical • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

First evaluation of novel cmoep (Liposomal Mitoxantrone-Based Chemotherapy) in front-line peripheral T-cell lymphoma: The compass Phase II study (ASH 2025) - P2 | "Pts received Lipo-MIT(18 mg/m2) combined with COEP regimen (cyclophosphamide at 750 mg/m2 on day 1, vincristine at 1.4mg/m2 on day 1, etoposide at 60 mg/m2 on days 1-3, and prednisone at 100 mg on days 1-5) every 21days for six cycles. Building on the completed phase I results, initiation of a phase II trial has demonstratedencouraging efficacy and manageable safety in pts with TN-PTCL. The Phase II trial is currently ongoing."

P2 data • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Combination of mitoxantrone hydrochloride liposome with chidamide in patients with relapsed or refractory peripheral T cell lymphoma: Updated results of the phase II study (ASH 2025) - P1/2 | "The Lipo-MIT-CHI regimen showed a promising efficacy and manageable safety in patientswith R/R PTCL."

Clinical • P2 data • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Bispecific antibodies serve as a safe and effective bridging therapy prior to CD19 CAR T-cell therapy/combinational therapy of CD19 CAR-T cell and HDT/ASCT in patients with R/R DLBCL (ASH 2025) - "The median number ofprior treatment lines before bridging therapy was 2 (range 1-4).Bridging therapy consisted of glofitamab monotherapy (3 patients) or glofitamab combined withchemotherapy (GVM [gemcitabine, vinorelbine, mitoxantrone hydrochloride liposome] in 4patients; GemOx [gemcitabine, oxaliplatin] in 4 patients). These preliminary data suggest that BsAbs-containing bridging therapy prior toCD19-specific CAR-T therapy, either alone or combined with HDT/ASCT, is effective and safe inDLBCL. More detailed data will be presented at the conference."

CAR T-Cell Therapy • Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • TP53

Daratumumab and venetoclax-based combined regimen for relapsed/refractory T-lymphoblastic leukemia/lymphoma (ASH 2025) - "Additionally, some patients received liposomal mitoxantroneand pegaspargase as part of their treatment. The combined regimen of Dara and Ven achieved an overall response rate (ORR) of 75.0%, with acomplete remission (CR) rate of 58.8%. The Dara and Ven regimen demonstrates a high response rate and well-tolerated treatmentoption for patients with relapsed/refractory T-ALL/LBL. It can serve as a bridging treatment for patientswho have not undergone allo-HSCT. For patients who experience relapse after allo-HSCT, it can also beused as a maintenance therapy to extend disease-free survival."

Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • T Acute Lymphoblastic Leukemia

Mitoxantrone hydrochloride liposome-based CMOP±R regimen achieves superior response in treatment-Naïve non-Hodgkin lymphoma: A phase III clinical trial with matching-adjusted indirect comparison (ASH 2025) - P2 | "The CMOP regimen, comprising cyclophosphamide,mitoxantrone hydrochloride liposome (Lipo-MIT), vincristine, and prednisone, has demonstrated efficacyin treating newly diagnosed peripheral T-cell lymphoma (PTCL) (Huang et al., ASH 2022, Abstract #1632).However, its efficacy in other NHL subtypes remains unclear...MAIC demonstrated that CMOP±R achieved superior responses overconventional regimens in DLBCL (weighted ORR: CMOP+R 100% vs. RCHOP 83.8% or Pola-R-CHP 85.5%,P0.05), or in PTCLpatients (weighted ORR: CMOP 100% vs. CHOP 60.5%, P<0.05; weighted CR rate: CMOP 75.9% vs. CHOP37.1%, P<0.05)...The CMOP±R regimen demonstrated promising efficacy as a first-line treatment for NHL, whilemaintaining a manageable safety profile. Updated data incorporating additional patients will be reportedsubsequently."

Clinical • P3 data • Atrial Fibrillation • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • CD20

R-cmop and pola-R-CMP regimens as first-line treatment for diffuse large B-cell lymphoma with cardiac comorbidity: A prospective, single-arm, multicenter study (ASH 2025) - P=N/A | "The median age at diagnosis is around 65 years, with 30% of patients aged > 75.While the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)achieves cure rates of 60%-70%, its anthracycline component (doxorubicin) causes significantcardiotoxicity, precluding its use in patients with pre-existing cardiac dysfunction or cardiovascular riskfactors (e.g., coronary artery disease, hypertension, valvular heart disease)...Mitoxantrone hydrochloride liposome (Lipo-MIT), as a modifiedformulation of the anthracycline drug mitoxantrone, possesses the characteristic of reducingcardiotoxicity.Aim:This prospective, single-arm, multicenter trial evaluated the safety and efficacy of first-line R-CMOP(rituximab, cyclophosphamide, Lipo-MIT, vincristine, prednisone) or Pola-R-CMP (polatuzumab vedotin,rituximab, cyclophosphamide, Lipo-MIT, prednisone) in newly diagnosed DLBCL patients with cardiaccomorbidity or those experiencing cardiac adverse..."

Clinical • B Cell Lymphoma • Coronary Artery Disease • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Malignancies • Hypertension • Lymphoma • Non-Hodgkin’s Lymphoma

Mitoxantrone hydrochloride liposome, gemcitabine, vinorelbine with or without anti-CD20 antibody (GVM±CD20) in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma: A prospective, multicenter, Phase Ⅱ study (ASH 2025) - P2 | "Background :Platinum-based salvage chemotherapy is the most widely used treatment approach for relapsed orrefractory aggressive non-Hodgkin lymphoma (R/R aNHL), with an objective response rate (ORR) of 42.0–63.5% and a complete response (CR) rate of 13.5-40.0%.We previously reported the efficacy and safety ofa novel non-platinum-based salvage regimen—GVM±R (mitoxantrone hydrochloride liposome [Lipo-MIT],gemcitabine, vinorelbine, with or without rituximab)—in R/R aNHL, demonstrating promising activity withan ORR of 66.7% and a CR rate of 50.0% (ESMO 2024, Abstract #833P). The GVM±CD20 regimen exhibited encouraging efficacy in R/R aNHLs, including refractory cases. Themost common treatment-related toxicities were hematologic adverse events, which were manageablewith supportive care but required close monitoring. The phase II trial is currently ongoing."

Clinical • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia