Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials

. 2025 Nov 25 ; 9 (22) : 5708-5719.

Jazyk angličtina Země Spojené státy americké Médium print

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid40763276

Belantamab mafodotin (belamaf) combined with standard therapies demonstrated significant progression-free survival (PFS) and overall survival benefits in DREAMM-7 and PFS benefit in DREAMM-8 in relapsed/refractory multiple myeloma. Belamaf dose modifications managed adverse events, including belamaf-related ocular events. Ocular events included ocular adverse reactions (eg, dry eyes, photophobia, eye irritation) and protocol-mandated ophthalmic examination findings. Protocol-recommended dose modifications for ocular events were driven by ophthalmic examination findings and included belamaf dose delays until resolution and reductions. We used descriptive analyses to evaluate the impact of dose modifications on managing ocular events and treatment efficacy. In patients with normal baseline vision who were receiving treatment, dose modifications extended belamaf dosing intervals to a median of 8 to 12 weeks by 9 months; the prevalences of reduced vision to bilateral 20/50 or worse and ocular adverse reactions were highest in the first 3 months and remained low at later time points. The median time to resolution after grade ≥2 ophthalmic examination findings was 12 weeks. Rates of belamaf discontinuations due to ocular events were low. Almost all responders (partial response or better) required dose modifications. Most patients achieved a response before an extended (>2 cycles) dose delay; most who had not, subsequently achieved or deepened their response. In DREAMM-7 and DREAMM-8, the median PFS in patients with ≥1 dose delay of ≥12 weeks was 36.6 months and not reached, respectively. Ocular events were common but effectively managed with dose modifications, allowing for patients to remain on treatment and derive robust efficacy benefit. The trials were registered at www.clinicaltrials.gov as #NCT04246047 (DREAMM-7) and #NCT04484623 (DREAMM-8).

1st Faculty of Medicine Charles University and General Hospital Prague Czech Republic

4th Department of Internal Medicine Hematology University Hospital Hradec Králové Faculty of Medicine in Hradec Králové Charles University Hradec Králové Czech Republic

Clínica São Germano São Paulo Brazil

Department of Clinical Therapeutics School of Medicine National and Kapodistrian University of Athens Athens Greece

Department of Hematology Liv Hospital Ankara İstinye University Ankara Turkey

Department of Hematooncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic

Department of Medical and Surgical Sciences University of Bologna Bologna Italy

Department of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada

Department of Medicine Korea University Seoul Republic of Korea

Division of Clinical Oncology Hematology Department of Internal Medicine The Jikei University School of Medicine Tokyo Japan

General Hospital Evangelismos Athens Greece

Gorodskaya Klinicheskaya Bol'nitsa Im S p Botkina Moscow Russia

GSK Collegeville PA

GSK London United Kingdom

GSK Mississauga ON Canada

GSK Research Triangle Park NC

GSK Stevenage United Kingdom

GSK Waltham MA

Hematology Unit Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Istituto di Ricovero e Cura a Carattere Scientifico Meldola Italy

Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo Universidade de São Paulo São Paulo Brazil

Hospital Universitario de Salamanca Instituto de Investigación Biomédica de Salamanca Cancer Research Center Ciberonc Salamanca Spain

Leningrad Regional Clinical Hospital Saint Petersburg Russia

Medical University of Łódź Łódź Poland

Medical University of Lublin Lublin Poland

Royal Prince Alfred Hospital and University of Sydney Camperdown NSW Australia

St Vincent's Hospital Melbourne University of Melbourne Melbourne VIC Australia

Sungkyunkwan University Samsung Medical Center Seoul Republic of Korea

The 1st Affiliated Hospital of Soochow University Jiangsu China

The Royal North Shore Hospital Sydney NSW Australia

Universidade da Região de Joinville and Centro de Hematologia e Oncologia Joinville Brazil

Zobrazit více v PubMed

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A study of belantamab mafodotin administered in combination with lenalidomide and dexamethasone (BRd) versus daratumumab, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (TI-NDMM) (DREAMM-10). ClinicalTrials.gov identifier: NCT06679101. Updated 6 August 2025. https://clinicaltrials.gov/study/NCT06679101

A study to investigate the safety and efficacy of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatments (DREAMM-20). ClinicalTrials.gov identifier: NCT05714839. Updated 5 June 2025. https://clinicaltrials.gov/study/NCT05714839

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Zobrazit více v PubMed

ClinicalTrials.gov
NCT04246047, NCT04484623

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