Safety and efficacy of belantamab mafodotin with pembrolizumab in patients with relapsed or refractory multiple myeloma
Suvannasankha, Attaya (Indiana University Simon Cancer Center and Roudebush VAMC)
Bahlis, Nizar (University of Calgary Arnie Charbonneau Cancer Research Institute)
Trudel, Suzanne (Princess Margaret Cancer Centre (Toronto, Canadà))
Weisel, Katja (University Medical Center Hamburg-Eppendorf)
Koenecke, Christian (Hannover Medical School. Clinic for Hematology. Hemostasis. Oncology and Stem Cell Transplantation)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Voorhees, Peter M. (Levine Cancer Institute. Atrium Health/Wake Forest University School of Medicine)
Alonso, Aranzazu A (Grupo Quirónsalud)
Callander, Natalie S. (University of Wisconsin)
Mateos, M. V (Hospital Universitario de Salamanca)
Reddy, Nishitha (Merck & Co.. Inc)
Hakim, Shawn (GlaxoSmithKline)
LaMacchia, John (GlaxoSmithKline)
Patel, Nashita (GlaxoSmithKline)
Williams, Danaé (GlaxoSmithKline)
Jewell, Roxanne C. (GlaxoSmithKline)
Zhou, Xiangdomg (GlaxoSmithKline)
Gupta, Ira (GlaxoSmithKline)
Opalinska, Joanna (GlaxoSmithKline)
Nooka, Ajay K. (Emory University Hospital)

Fecha:	2024
Resumen:	Background: Belantamab mafodotin (belamaf) has shown promising antimyeloma activity in relapsed or refractory multiple myeloma (RRMM) as a single agent. It was hypothesized that its multimodal activity may be enhanced by programmed cell death protein 1 pathway inhibition and activation of T cell-mediated antitumor responses. This study investigated the efficacy and safety of belamaf with pembrolizumab in patients with RRMM. Methods: DREAMM-4 (NCT03848845) was an open-label, single-arm, phase 1/2 study divided into dose-escalation (part 1) and dose-expansion (part 2) phases. Patients were ≥18 years old with ≥3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 agent. Patients received belamaf (2. 5 or 3. 4 mg/kg, part 1; 2. 5 mg/kg, part 2) and 200 mg pembrolizumab for ≤35 cycles. Results: Of 41 enrolled patients, 34 (n = 6 part 1, n = 28 part 2) who received 2. 5 mg/kg belamaf plus pembrolizumab were included in this final analysis. Sixteen patients (47%) achieved an overall response. Minimal residual disease negativity was achieved in three of 10 patients who had very good partial response or better. Five of eight patients who had prior anti-B-cell maturation antigen therapy achieved partial response or better, including two who had B-cell maturation antigen-refractory disease. Common grade ≥3 adverse events were keratopathy (38%) and thrombocytopenia (29%). Despite belamaf-related ocular events, quality-of-life measures remained stable over time. No new safety signals were observed. Conclusions: The results of DREAMM-4 demonstrated clinical activity and a favorable safety profile of belamaf plus pembrolizumab in patients with RRMM.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Belantamab mafodotin ; Pembrolizumab ; Refractory multiple myeloma ; Dose-escalation ; Dose-expansion ; Benefit-risk profile ; Safety
Publicado en:	Cancer, Vol. 130 Núm. 15 (August 2024) , p. 2629-2641, ISSN 1097-0142

DOI: 10.1002/cncr.35319

13 p, 633.7 KB

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Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Instituto de Investigación contra la Leucemia Josep Carreras
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