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hutchings-et-al-2025-efficacy-and-safety-of-glofitamab-plus-polatuzumab-vedotin-in-relapsed-refractory-large-b-cell.pdf (469.1 KB)

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2025-10-20

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cc-by-nc-nd (c) American Society of Clinical Oncology, 2025
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/228755

Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial

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https://doi.org/10.1200/JCO-25-00992

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PURPOSEAn unmet need remains for more effective therapies for relapsed/refractory (R/R) large B-cell lymphoma (LBCL), especially high-grade B-cell lymphoma (HGBCL). We present the primary analysis of a phase Ib/II study (ClinicalTrials.gov identifier: NCT03533283) investigating efficacy and safety of glofitamab plus polatuzumab vedotin (Glofit-Pola) in patients with R/R LBCL, including HGBCL and those who received previous chimeric antigen receptor (CAR) T-cell therapy.METHODSPatients received 1,000 mg obinutuzumab on Cycle (C)1 Day (D)1 (once daily). Polatuzumab vedotin (1.8 mg/kg) was given on C1D2 and D1 of C2-6 (21-day cycles; once daily). Glofitamab was given as step-up doses in C1 (D8, 2.5 mg; D15, 10 mg) followed by 30 mg on D1 of C2-12 (21-day cycles; once daily). Polatuzumab vedotin was given for six fixed-duration cycles, and glofitamab for 12.RESULTSAs of September 2, 2024, 129 patients with LBCL (HGBCL; n = 44, 34.1%), received >= 1 dose of study treatment. The median age was 67 years (range, 23-84), and 63.6% were male. Patients had received a median of 2 (range, 1-7) previous lines of treatment (previous CAR T-cell therapy, n = 28, 21.7%). The independent review committee-assessed overall response rate was 78.3% (complete response rate, 59.7%). The median progression-free survival and overall survival (OS) were 12.3 and 33.8 months, respectively (median OS follow-up time, 32.7 months). The most common adverse event (AE) was cytokine release syndrome (43.4%; grade 1-2: 41.9%; one grade 5 event). Grade 3-4 AEs occurred in 58.9% of patients; 9.3% had grade 5 AEs, and 14.7% discontinued treatment because of AEs.CONCLUSIONGlofit-Pola demonstrated high efficacy and durable responses, with manageable safety, in heavily pretreated patients with R/R LBCL, including patients with HGBCL and previous CAR T-cell therapy failure.

Matèries

Leucèmia limfocítica crònica, Tractament adjuvant del càncer

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Chronic lymphocytic leukemia, Adjuvant treatment of cancer

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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HUTCHINGS, Martin, SUREDA, Anna, BOSCH, Francesc, STAUFFER LARSEN, Thomas, CORRADINI, Paolo, AVIGDOR, Abraham, TEROL, María josé, RUEDA DOMINGUEZ, Antonio, PINTO, Antonio, SKARBNIK, Alan, CORDOBA, Raul, MESZAROS JØRGENSEN, Judit, ZINZANI, Pier luigi, LEUNG, Wilfred, BOTTOS, Alessia, LI, Donghang, RELF, James, TANDON, Maneesh, SELLAM, Gila, GRITTI, Giuseppe. Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. _Journal of Clinical Oncology_. 2025. Vol. 43, núm. 36, pàgs. 3788-3798. [consulta: 5 de maig de 2026]. ISSN: 1527-7755. [Disponible a: https://hdl.handle.net/2445/228755]

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