Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features : integrated analysis of two phase 3 studies
Burger, Jan A (Department of Leukemia. University of Texas MD Anderson Cancer Center)
Robak, Tadeusz (Medical University of Lodz. Copernicus Memorial Hospital)
Demirkan, Fatih (Dokuz Eylul University)
Bairey, Osnat (Rabin Medical Center (Petah-Tikva, Israel))
Moreno, Carolina (Institut d'Investigació Biomèdica Sant Pau)
Simpson, David (BeiGene)
Munir, Talha (Department of Haematology. St. James's Hospital)
Stevens, Don A. (Norton Cancer Institute)
Dai, Sandra (Pharmacyclics LLC. an AbbVie Company)
Cheung, Leo W.K (Pharmacyclics LLC. an AbbVie Company)
Kwei, Kevin (Pharmacyclics LLC. an AbbVie Company)
Lal, Indu (Pharmacyclics LLC. an AbbVie Company)
Hsu, Emily (Pharmacyclics LLC. an AbbVie Company)
Kipps, Thomas J (University of California San Diego. Moores Cancer Center)
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda)

Fecha:	2022
Resumen:	Genomic abnormalities, including del(17p)/TP53 mutation, del(11q), unmutated IGHV, and mutations in BIRC3, NOTCH1, SF3B1, and XPO1 predict poor outcomes with chemoimmunotherapy in chronic lymphocytic leukemia. To better understand the impact of these high-risk genomic features on outcomes with first-line ibrutinib-based therapy, we performed pooled analysis of two phase 3 studies with 498 patients randomized to receive ibrutinib- or chlorambucil-based therapy with median follow-up of 49. 1 months. Ibrutinib-based therapy improved overall response rates (ORRs), complete response rates, and progression-free survival (PFS) versus chlorambucil-based therapy across all subgroups. In ibrutinib-randomized patients with versus without specified genomic features, ORR and PFS were comparable across subgroups. PFS hazard ratio (95% CI) for del(17p)/TP53 mutated/BIRC3 mutated: 1. 05 (0. 54-2. 04); del(17p)/TP53 mutation, del(11q), and/or unmutated IGHV: 1. 11 (0. 69-1. 77); unmutated IGHV: 1. 79 (0. 99-3. 24); and NOTCH1 mutated 1. 05 (0. 65-1. 69). This integrated analysis demonstrated efficacy of first-line ibrutinib-based treatment irrespective of cytogenetic and mutational risk features. Registered at ClinicalTrials. gov (NCT01722487 and NCT02264574).
Nota:	Altres ajuts: Pharmacyclics LLC; AbbVie Company.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Chronic lymphocytic leukemia ; Ibrutinib ; Chlorambucil ; Obinutuzumab ; Pooled analysis
Publicado en:	Leukemia and Lymphoma, Vol. 63 Núm. 6 (2022) , p. 1375-1386, ISSN 1029-2403

DOI: 10.1080/10428194.2021.2020779
PMID: 35014928

13 p, 1.9 MB

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