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Baseline Characteristics from CLL-ZANU2024, an Italian Non-Interventional Study Assessing the Real-World Use of Zanubrutinib in the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

Introduction: Zanubrutinib, a selective second-generation irreversible Bruton Tyrosine Kinase (BTK) inhibitor, received European Medicines Agency (EMA) approval in November 2022 for the chronic lymphocytic leukemia (CLL) treatment and Agenzia Italiana del Farmaco (AIFA) reimbursement as monotherapy...

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Published in:Blood 2024-11, Vol.144 (Supplement 1), p.6794-6794
Main Authors: Martino, Enrica Antonia, Pasquale, Raffaella, Ferrarini, Isacco, Moia, Riccardo, Visentin, Andrea, Sanna, Alessandro, Motta, Marina, Moratti, Massimo, Sportoletti, Paolo, Chiarenza, Annalisa, Maggi, Alessandro, Zammit, Valentina, Merli, Michele, Innocenti, Idanna, Giordano, Claudia, Nocilli, Laura, Postorino, Massimiliano, Stelitano, Caterina, Ferrario, Andrea, Frustaci, Annamaria, Scardino, Stefania, Anticoli Borza, Paola, Ballotta, Laura, Mancuso, Salvatrice, Musuraca, Gerardo, Mele, Anna, Galimberti, Sara, Catania, Gioacchino, Giordano, Annamaria, Angeletti, Ilaria, Schiattone, Luana, Pennese, Elsa, Miccolis, Rosanna, Fama, Angelo, Giordano, Giulio, Califano, Catello, Vigna, Ernesto, Bruzzese, Antonella, Farina, Giuliana, Bulian, Pietro, Loseto, Giacomo, Pocali, Barbara, Innao, Vanessa, Galieni, Piero, Fraticelli, Vincenzo Ludovico, Vitale, Candida, Romeo, Azzurra Anna, Rossi, Marco, Scortechini, Ilaria, Vozzella, Federico, Malandruccolo, Luigi, Derenzini, Enrico, di Martina, Valentina, Marasca, Roberto, Del Principe, Maria Ilaria, Coscia, Marta, Di Renzo, Nicola, Laurenti, Luca, Neri, Antonino, Musto, Pellegrino, Di Raimondo, Francesco, Tedeschi, Alessandra, Trentin, Livio, Gaidano, Gianluca, Morabito, Fortunato, Gattei, Valter, Gentile, Massimo
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Language:English
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Summary:Introduction: Zanubrutinib, a selective second-generation irreversible Bruton Tyrosine Kinase (BTK) inhibitor, received European Medicines Agency (EMA) approval in November 2022 for the chronic lymphocytic leukemia (CLL) treatment and Agenzia Italiana del Farmaco (AIFA) reimbursement as monotherapy in October 2023. Despite this, further evaluation of Zanubrutinib in real-world post-marketing settings is necessary. The CLL-ZANU2024 study, an Italian, observational, multicenter, longitudinal secondary data usage analysis, aims to address this need by retrospectively examining a cohort of CLL patients who initiated Zanubrutinib between October 2023 and June 2024, regardless of their treatment status at the time of inclusion. Methods: CLL-ZANU2024 study started in May 2024 (first-patient in), and aimed to enroll CLL patients (pts) across 52 Italian sites. The study provides the first Italian real-world data on Zanubrutinib use in CLL. The primary end-point of this study was to evaluate the time to treatment discontinuation (TTD) and reasons for discontinuation in pts with CLL, both overall and according to treatment lines. Pts will be prospectively observed for up to 5 years since the last patient's index date or until study withdrawal (consent withdrawal, physician's choice, loss to follow-up or death), whichever occurs first, regardless of Zanubrutinib discontinuation. All visits and assessments are conducted as per site clinical practice. Descriptive statistics is used for baseline characteristics. Results: As of June 2024, 203 pts were identified and included for demographic and baseline characteristics analysis. The median age was 75.9 years (range 45.8-94.5), and 129 pts (63.2%) were male. Zanubrutinib was first treatment in 128 (62.7%) pts (treatment-naïve, TN) pts and subsequent therapy in 77 (37.3%) pts (refractory/relapsed, RR). The median time from diagnosis to Zanubrutinib initiation was 2.2 years (range 0.2-18.4) in TN pts and 8.8 years (range 1.5-33) in RR pts. Binet classification at treatment start was: A stage (24 pts; 11.8%), B stage (71 pts; 34.8%), C stage (109 pts; 53.4%). Del(17p), del(11q), TP53 mutational status and IGHV mutational status data were available in 179 (87.9%), 171 (83.8%), 177 (86.8%) and 176 (86.3%) pts, respectively. Del(17p) was reported in 29 pts (16.2%; 16 TN, 13 RR), del(11q) in 30 pts (17.5%; 18 TN, 12 RR), TP53 mutations in 32 pts (15.7%; 16 TN, 16 RR). IGHV was unmutated in 122 pts (68.9%; 86 TN, 36 RR). In 169 ca
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2024-205354