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

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

Phase II Results of ECOG-ACRIN EA9152: A multicenter study of liposomal vincristine (L-VCR) or vincristine sulfate (VCR) and venetoclax (VEN) in relapsed or refractory acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LL) (ASH 2025) - "The combination of VEN at the established RP2D and L-VCR/VCR was feasible and had an acceptablesafety profile in heavily pretreated patients with R/R ALL/LL. However, response rates, including CR/CRiand MRD negativity, were limited, particularly in the B-cell cohort. Median OS and PFS remain poor inboth subtypes, highlighting the need for improved strategies in this high-risk population."

Clinical • P2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Respiratory Diseases

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

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 | "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. 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

Machine Learning-Guided microfluidic optimization of clinically inspired liposomes for nanomedicine applications. (PubMed, Int J Pharm) - "This study explores the application of machine learning algorithms to optimize the production of liposomes inspired by the compositions of two clinically validated formulations, Doxil® (currently approved) and Marqibo® (formerly approved), using a microfluidic production platform. All models were rigorously validated through independent sets of wet-lab experiments, demonstrating robust performance and adaptability even under resource-constrained conditions. Our findings highlight the transformative potential of machine learning to streamline liposome development, improve reproducibility, and enable cost-effective transition from research-scale to commercial manufacturing, while aligning with regulatory quality frameworks and GMP expectations, thereby supporting the adoption of Quality by Design principles in the advancement of nanomedicine."

Journal

"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" (DGHO 2025) - P3 | "Introduction: 6 cycles (cy) R-CHOP chemotherapy (ChT) are standard of care in elderly DLBCL patients (pts)...In r/r aggressive lymphoma liposomal (lip) vincristine sulfate (Marqibo®) showed high activity and higher tolerability compared to conventional (conv) VCR... In elderly pts with less fav DLBCL bulk RT can be spared safely in PET neg pts. Neither lip VCR nor increasing number and modifying schedule of R resulted in a significantly better outcome compared to 6xR-CHOP+2R. Overall, outcome significantly improved in OPTIMAL>60.Supported by Acrotech Biopharma, Roche Pharma, Amgen"

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

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: Sep 2025 ➔ Mar 2026

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

Case Report of Long-Term Complete Remission with Liposomal Doxorubicin for Treatment of Cardiac Involvement in Diffuse Large B-Cell Lymphoma. (PubMed, J Vis Exp) - "Immunochemotherapy with rituximab, cyclophosphamide, doxorubicin hydrochloride liposomes, vincristine, and prednisone (R-CDOP) was initiated, with dose adjustments for cardiac toxicity. Close monitoring and management of cardiac complications are critical for favorable outcomes. The individualized treatment approach, including dose modification and specific management of cardiac complications, played a key role in the patient's successful treatment."

Journal • B Cell Lymphoma • Cardiovascular • Cough • Diffuse Large B Cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases

Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Therapeutic Advances in Childhood Leukemia Consortium | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Dec 2024

Trial completion • Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Medical College of Wisconsin | N=33 ➔ 11 | Trial completion date: May 2026 ➔ Oct 2027 | Trial primary completion date: May 2026 ➔ May 2025 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

Channel-size enlarging strategy for liposome production scale-up: A simplified approach. (PubMed, Int J Pharm) - "Firstly, to characterize the platform, the influence of TFR and diverse flow regimes on size and Polidispersity Index (PDI) of empty-Doxil® liposomes was investigated. This scaling approach was also applied to empty Marqibo® and DOTAP nanoparticles, achieving consistent results across scales. Our findings point out the scalability, efficiency and adaptability of this strategy, bridging the gap between laboratory innovation and industrial implementation and offering practical insights into liposome engineering through fluidic control."

Journal

NCI-2018-01198: Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • BCL2

Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=17 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=12 ➔ 17

Enrollment change • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Postbiotics: Modulation of the Gut Microbiota and Potential for Association with Nanotechnology. (PubMed, Probiotics Antimicrob Proteins) - "In the pharmaceutical industry, several nanotechnology-based delivery systems have already been approved by the FDA and successfully marketed, demonstrating their clinical and industrial viability, such as Abraxane®, Doxil® (or Caelyx®), Onivyde®, Marqibo®, and Vyxeos®...However, although nanotechnology in the delivery of postbiotics is an emerging and innovative field with promising preclinical studies, the lack of consolidated clinical or commercial data means that this topic needs to be expanded in order to achieve standardization and clinical validation. This review aims to highlight the importance of postbiotics in the modulation of gut microbiota and in the prevention/treatment of disease, as well as the potential of using nanotechnology to facilitate the targeting of these compounds and the limitations of using these systems for such applications."

Journal • Review • Gastrointestinal Disorder

EXCELLENT OUTCOME WITH INTERIM PET ADAPTED TREATMENT REDUCTION IN ELDERLY DLBCL PTSWITH FAVOURABLE PROGNOSIS: RESULTS OF 288 PTS TREATED IN OPTIMAL > 60 OF THE DSHNHL/GLA (ICML 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. PET adapted treatment strategy resulted in excellent PFS and OS comparable to elderly favpats 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 • Lymphoma • Oncology

PET GUIDED OMISSION OF RADIOTHERAPY IN ELDERLY DLBCL PTS WITH LESS FAVOURABLE PROGNOSIS IS SAFE: RESULTS OF 863 PATIENTS TREATED IN THE OPTIMAL > 60 TRIAL OF THE DSHNHL/GLA (ICML 2025) - P3 | "Inrelapsed/refractory aggressive lymphoma liposomal (lip) vincristine sulfate (Marqibo) has shown high activity and highertolerability 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 • Lymphoma • Oncology

THE CMOP ± R REGIMEN SHOWS HIGH EFFICACY AS A FIRST-LINE TREATMENT FOR NHL: A PHASE II CLINICAL TRIAL WITH MATCHING-ADJUSTED INDIRECT TREATMENT COMPARISON ANALYSIS (ICML 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) (Huang et al., ASH 2022 abstract 1632)...The MAIC analysis in DLBCL 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 • Diffuse Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

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

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

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

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

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