Marqibo (vincristine liposomal) / Servier, CASI, Aurobindo - LARVOL DELTA

ECOG-ACRIN EA9152: Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial primary completion date: Dec 2028 ➔ Dec 2025

IO biomarker • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2

Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. (ASCO 2025) - "Pepaxto was excluded from our analysis as it had no reported payments on OpenPayments...Following announcement of negative postapproval confirmatory study results, average monthly payments received by all physicians increased for Marqibo (vinCRIStine sulfate) from $138 in the year preceding announcement to $164 during the period between announcement of negative results and market withdrawal, but decreased for Farydak (panobinostat) ($12,317 to $4,916), Blenrep (belantamab mafodotin) ($152,417 to $119,394), and Ukoniq (umbralisib) ($23,139 to $14,130). Lartruvo (olaratumab) and Aliqopa (copanlisib) had almost no payments after announcement of negative confirmatory study results. Industry payments for oncology drugs with accelerated approvals mostly decreased after announcement of negative confirmatory trial results; however, there was evidence of continued promotion for certain drugs until a request for voluntary withdrawal was made by FDA. This suggests that regulatory..."

Oncology

Nanotechnology in Hematology: Enhancing Therapeutic Efficacy With Nanoparticles. (PubMed, Health Sci Rep) - "Various NP formulations have shown promise in clinical trials, including liposomal formulations like Vyxeos for acute myeloid leukemia and Marqibo for Ph-negative acute lymphoblastic leukemia...Nanomedicine holds transformative potential in the treatment of hematological malignancies, offering more effective and specific therapies compared to conventional treatments. Continued research is necessary to overcome the clinical challenges and maximize the benefits of NP-based therapies for patients with blood cancers."

Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Oncology

EXCELLENT OUTCOME WITH INTERIM PET ADAPTED TREATMENT REDUCTION IN ELDERLY DLBCL PTS WITH FAVOURABLE PROGNOSIS: RESULTS OF 288 PTS TREATED IN OPTIMAL>60 TRIAL OF THE DSHNHL/GLA (EHA 2025) - P3 | "Higher activity and less polyneuropathy (PNP) had been reported for liposomal (lip) compared to conventional (conv) vincristine (VCR) sulfate (Marqibo®) in r/r aggressive lymphoma (Rodriguez et al, Cancer, 2009)... PET adapted treatment strategy resulted in excellent PFS and OS comparable to elderly fav pats treated with 6xR-CHOP+2R in RICOVER-60 and even in a similar cure rate as in younger fav pts in FLYER. Substitution of conv by lip VCR resulted in significant more neurotoxicity without improving outcome. PET-4 adapted treatment with R-CHOP is save and results in reduced treatment exposure in 2/3 of elderly pts with fav DLBCL."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Pain

PET GUIDED OMISSION OF RADIOTHERAPY IN ELDERLY DLBCL PATIENTS WITH LESS FAVOURABLE PROGNOSIS IS SAFE: RESULTS OF 863 PATIENTS TREATED IN THE OPTIMAL>60 TRIAL OF THE DSHNHL/GLA (EHA 2025) - P3 | "In relapsed/refractory aggressive lymphoma liposomal (lip) vincristine sulfate (Marqibo®) has shown high activity and higher tolerability compared to conventional (conv) VCR (Rodriguez et al, Cancer, 2009)... In elderly pts with less fav DLBCL RT to bulk can be spared safely in PET neg pts.Neither lip VCR nor increasing number and modifying schedule of rituximab resulted in a significantly better outcome compared to 6xR-CHOP+2R. Overall, outcome significantly improved in OPTIMAL>60."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology

THE CMOP±R REGIMEN SHOWS HIGH EFFICACY AS A FIRST-LINE TREATMENT FOR NON-HODGKIN'S LYMPHOMA: A PHASE II CLINICAL TRIAL WITH MATCHING-ADJUSTED INDIRECT TREATMENT COMPARISON (MAIC) ANALYSIS (EHA 2025) - P=N/A | "The CMOP regimen, comprising cyclophosphamide, mitoxantrone hydrochloride liposome, vincristine, and prednisone, has shown efficacy in treating newly diagnosed peripheral T-cell lymphoma (PTCL), as reported in a recent study (Huang et al., ASH 2022 abstract 1632)...The MAIC analysis in DLBCL patients showed that CMOP±R achieved a slightly improved response compared to the R-CHOP (weighted ORR 94.6% vs 83.8%, P=0.126; weighted CRR 82.2% vs 74.0%, P=0.485) or pola-R-CHP arm (weighted ORR 94.6% vs 85.5%, P=0.196; weighted CRR 82.2% vs 78.0%, P=0.721) from the POLARIX study... The CMOP±R regimen exhibited notable efficacy as a first-line treatment for NHL, while maintaining a manageable safety profile. Based on the MAIC results, CMOP±R is associated with a favorable response in patients with DLBCL."

Clinical • P2 data • Anemia • Atrial Fibrillation • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

CLINICAL EFFICACY OF XPO-1 INHIBITOR COMBINED WITH PD-1 MONOCLONAL ANTIBODY, CD20 MONOCLONAL ANTIBODY, AND MOED REGIMEN IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: A SINGLE-CENTER RETROSPECTIVE STUDY (EHA 2025) - "The regimen comprised an XPO-1 inhibitor, PD-1 monoclonal antibody, CD20 monoclonal antibody, and MOED (mitoxantrone liposome, vincristine, etoposide, dexamethasone). The XPO-1 inhibitor-based combination regimen demonstrated promising efficacy and manageable toxicity in R/R , potentially offering a new therapeutic option for high-risk patients. Larger-scale studies are warranted to validate survival benefits."

Retrospective data • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • XPO1

AREN0533: Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor (clinicaltrials.gov) - P3 | N=395 | Active, not recruiting | Sponsor: Children's Oncology Group

Trial completion date • Lung Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Solid Tumor • Wilms Tumor

Vincristine Sulfate Liposome Injection with Combination Chemotherapy for Children, Adolescents, and Young Adults with Relapsed Acute Lymphoblastic Leukemia: A Therapeutic Advances in Childhood Leukemia and Lymphoma Consortium Trial. (PubMed, Pediatr Blood Cancer) - P1 | "Based on the promising response signal in this heavily pretreated population, further study of VSLI is warranted. (ClinicalTrials.gov NCT02879643)."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Phase I/II clinical study of rituximab combined with cyclophosphamide, Mitoxantrone hydrochloride liposome, vincristine and prednisone in the treatment of newly diagnosed large B-cell lymphoma with bulky disease (ChiCTR) - P4 | N=51 | Recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New P4 trial • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • ALK

Cyclophosphamide, Mitoxantrone Hydrochloride Liposome, Vincristine, and Prednisone Regimen with or without Rituximab (CMOP±R) Shows High Efficacy As a First-Line Treatment for Non-Hodgkin's Lymphoma: A Phase II Clinical Trial with Matching-Adjusted Indirect Treatment Comparison (MAIC) Analysis (ASH 2024) - P=N/A | "Conclusions : The CMOP±R regimen exhibited notable efficacy as a first-line treatment for NHL, particularly in patients with advanced-stage disease, while maintaining a manageable safety profile. Based on the MAIC results, CMOP±R is associated with a favorable response in patients with DLBCL."

Clinical • P2 data • Anemia • Atrial Fibrillation • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

R-Cmop and Pola-R-CMP Regimes As First-Line Treatment for Diffuse Large B-Cell Lymphoma with Cardiac Comorbidity (ASH 2024) - "For several decades, the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) has been the backbone of DLBCL treatment, achieving overall cure rates in the range of 60% to 70%...Therefore, there is a need for a novel treatment approach for these patients.Aims : The study was a prospective, single-arm, multicenter clinical trial to evaluate the safety and efficacy of R-CMOP (rituximab, cyclophosphamide, mitoxantrone hydrochloride liposome, vincristine, prednisone) or Pola-R-CMP (polatuzumab vedotin, rituximab, cyclophosphamide, mitoxantrone hydrochloride liposome, prednisone) regimes as first-line therapy for newly diagnosed DLBCL with cardiac comorbidity or in whom cardiac adverse events happened after 1-3 cycles R-CHOP treatment.Methods : Adult patients with newly diagnosed DLBCL with cardiac comorbidity or in whom cardiac adverse events happened after 1-3 cycles R-CHOP treatment...The most common grade 3/4 TRAEs with an incidence of..."

Clinical • Anemia • B Cell Lymphoma • Cardiovascular • Coronary Artery Disease • Diffuse Large B Cell Lymphoma • Heart Failure • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases

ECOG-ACRIN EA9152: Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2

A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia: Results from the ECOG-ACRIN EA9152 protocol. (PubMed, EJHaem) - P1/2 | "The combination of VEN and L-VCR was found to be safe for patients with r/r ALL and encouraging preliminary efficacy, including MRD negative responses. With the removal of L-VCR from the US market, the phase 2 portion of this trial is actively enrolling with vincristine sulfate."

Combination therapy • Journal • P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

« Tailor-made vincristine-liposomes for tumor targeting». (PubMed, Biochimie) - "Confocal microscopy revealed the intracellular release of vincristine, evidenced by disrupted mitosis-specific labeling of actin filaments in metastatic prostate cell lines. This highlights the crucial role of membrane fluidity in the development of lipid-based drug carriers, offering a promising and cost-effective option for targeting cancer cells as an alternative to conventional strategies."

Journal • Breast Cancer • Oncology • Prostate Cancer • Solid Tumor

Scalable microfluidic method for tunable liposomal production by a design of experiment approach. (PubMed, Int J Pharm) - "Starting from a Doxil®-like formulation (HSPC, MPEG-DSPE and cholesterol), a rational approach (Design of Experiments, DoE) was applied for the screening of the process parameters affecting the quality attributes of the product (mainly size and polydispersity). The procedure was applied to a Marqibo®-like formulation as well (sphingomyelin and cholesterol) to show the generality of the proposed formulation, process development and scale-up approach. The application of the system and method herein presented enables the large-scale manufacturing of liposomes, in compliance with the internationally recognized regulatory standards for pharmaceutical development (Quality by Design)."

Journal

Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; The study was terminated early because copanlisib was removed from the market by the Food and Drug Administration (FDA) and the manufacturer.

Trial termination • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BCL2 • BCL6

Research on the loading and release kinetics of the vincristine sulfate liposomes and its anti-breast cancer activity. (PubMed, Int J Pharm X) - "VCRS liposomes also enhanced in vitro and in vivo antitumor activity. Thus, VCRS liposomes showed great potential for VCRS delivery, and the loading and release kinetics were well researched to provide a reference for investigating active drug loading liposomes."

Journal • Breast Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

CYCLOPHOSPHAMIDE, MITOXANTRONE HYDROCHLORIDE LIPOSOME, VINCRISTINE, AND PREDNISONE REGIME WITH OR WITHOUT RITUXIMAB (CMOP±R) SHOWS HIGH EFFICACY AS A FIRST-LINE TREATMENT FOR NON-HODGKIN'S LYMPHOMA (EHA 2024) - "The CMOP±R regimen showed exceptional efficacy as a first-line treatment for NHL, especially in patients withadvanced disease, with acceptable and manageable adverse effects. The efficacy and safety profile of thisregimen will be further determined in future studies. Swimmer plot of each enrolled patient"

Clinical • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine (clinicaltrials.gov) - P3 | N=1152 | Completed | Sponsor: Universität des Saarlandes | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2024 | Trial primary completion date: May 2025 ➔ Jan 2024

Combination therapy • FDG PET • Trial completion • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • ALK • CD20

Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: May 2028 ➔ May 2026 | Trial primary completion date: May 2027 ➔ May 2026

Combination therapy • Trial completion date • Trial primary completion date • Burkitt Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine (clinicaltrials.gov) - P3 | N=1152 | Active, not recruiting | Sponsor: Universität des Saarlandes | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: Dec 2023 ➔ May 2025

Combination therapy • FDG PET • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • ALK • CD20

OPTIMAL>60 / DR. CHOP, Improvement of Therapy of Elderly Patients With CD20+ DLBCL Using Rituximab Optimized and Liposomal Vincristine (clinicaltrials.gov) - P3 | N=1152 | Active, not recruiting | Sponsor: Universität des Saarlandes | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • FDG PET • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • ALK • CD20

[VIRTUAL] First-line therapy DLBCL (DGHO 2020) - P3 | "Standard treatment front line therapy consists of the combination of rituximab (R) and CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone), given every 14 or 21 days...In elderly less-favorable pts (61-80 yr., IPI=1 (age), with bulk, IPI=2-5) the OPTIMAL>60 trial (NCT01478542) currently investigates the role of optimized R, liposomal vincristine and PET adapted administration of RT. Recently several trials testing the addition of new drugs e.g. Ibrutinib to R-CHOP did not show superiority (Younes et al., J Clin Oncol. R-CHOP remains the standard of care but further research is needed to optimize treatment management in front-line DLBCL"

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Medical College of Wisconsin | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Burkitt Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD19