DP044 | PRELIMINARY ANALYSIS OF CLL-ZANU2024, AN ITALIAN NON-INTERVENTIONAL STUDY ASSESSING THE REAL-WORLD USE OF ZANUBRUTINIB IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

The CLL-ZANU2024 study is an Italian, observational, multicenter, longitudinal secondary data analysis evaluating the safety and efficacy of Zanubrutinib in real-world post-marketing setting. It retrospectively examines chronic lymphocytic leukemia (CLL) patients who initiated Zanubrutinib from October 2023, regardless of prior treatment. The study aimed to enroll patients (pts) across 56 Italian sites, providing the first Italian real-world data register on Zanubrutinib in CLL. The primary end-point was time to treatment discontinuation (TTD) and reasons for discontinuation; the secondary end-point was time to next treatment or death (TTNTD). As of May 2024, 393 pts were included. Median age was 76 years (range 44-94), and 63.2% were male. Zanubrutinib was first-line treatment in 237 pts (60.3%) (treatment-naïve, TN) and subsequent-line therapy in 156 pts (39.7%) (refractory/relapsed, RR). At treatment start, Binet stage was: A in 10.4%, B in 38.4%, C in 51.1%. Del(17p), TP53 mutation, and IGHV status were available in 91.1%, 90.8%, and 87.8% of pts, respectively. Del(17p) was detected in 16.5% (31 TN, 28 RR), TP53 mutations in 20.2% (36 TN, 36 RR), and IGHV was unmutated in 70.1% (154 TN, 88 RR). Among 348 pts with both del(17p) and TP53 data, concomitant abnormalities were observed in in 9.5%, del(17p) only in 6.9%, and TP53-mutation only in 10.6%. Bulky lymph nodes (>10 cm) were observed in 6.4%. Most pts (75.8%) received an initial zanabrutinib dose of 320 mg/day, as per Summary of Product Characteristics (SmPC). At a median follow-up of 8 months (range 1-32) median TTD was not reached in the entire cohort nor in TN and RR subgroups (Figure 1A). The 12-month discontinuation rate was 10.6% overall (9.3% TN, 12.8% RR). Overall, 7.6% (30/393) of patients (18 TN, 12 RR) discontinued treatment. Main reasons were toxicity (15 pts) and disease progression (10 pts). Patients with a Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS) >3 had a significantly higher probability of discontinuating therapy (12-month discontinuation rate CFS < or =3 vs CFS>3: 6.2% vs 22.3%, P<0.0001) (Figure 1B), while IGHV status and TP53 disruption did not significantly impact on TTD. The 12-month TTNTD probability was 94.6% overall (95.8 % TN, and 92.5% RR). This preliminary report from the largest available real-world study on zanubrutinib in CLL confirms a favorable safety profile in both TN and RR settings, with a low rate of discontinuation.

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SHILAP Revista de lepidopterología
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2025-09-01
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Medical History and Research
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DP044 | PRELIMINARY ANALYSIS OF CLL-ZANU2024, AN ITALIAN NON-INTERVENTIONAL STUDY ASSESSING THE REAL-WORLD USE OF ZANUBRUTINIB IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

SHILAP Revista de lepidopterología
Medical History and Research
article

DP044 | PRELIMINARY ANALYSIS OF CLL-ZANU2024, AN ITALIAN NON-INTERVENTIONAL STUDY ASSESSING THE REAL-WORLD USE OF ZANUBRUTINIB IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

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Abstract

The CLL-ZANU2024 study is an Italian, observational, multicenter, longitudinal secondary data analysis evaluating the safety and efficacy of Zanubrutinib in real-world post-marketing setting. It retrospectively examines chronic lymphocytic leukemia (CLL) patients who initiated Zanubrutinib from October 2023, regardless of prior treatment. The study aimed to enroll patients (pts) across 56 Italian sites, providing the first Italian real-world data register on Zanubrutinib in CLL. The primary end-point was time to treatment discontinuation (TTD) and reasons for discontinuation; the secondary end-point was time to next treatment or death (TTNTD). As of May 2024, 393 pts were included. Median age was 76 years (range 44-94), and 63.2% were male. Zanubrutinib was first-line treatment in 237 pts (60.3%) (treatment-naïve, TN) and subsequent-line therapy in 156 pts (39.7%) (refractory/relapsed, RR). At treatment start, Binet stage was: A in 10.4%, B in 38.4%, C in 51.1%. Del(17p), TP53 mutation, and IGHV status were available in 91.1%, 90.8%, and 87.8% of pts, respectively. Del(17p) was detected in 16.5% (31 TN, 28 RR), TP53 mutations in 20.2% (36 TN, 36 RR), and IGHV was unmutated in 70.1% (154 TN, 88 RR). Among 348 pts with both del(17p) and TP53 data, concomitant abnormalities were observed in in 9.5%, del(17p) only in 6.9%, and TP53-mutation only in 10.6%. Bulky lymph nodes (>10 cm) were observed in 6.4%. Most pts (75.8%) received an initial zanabrutinib dose of 320 mg/day, as per Summary of Product Characteristics (SmPC). At a median follow-up of 8 months (range 1-32) median TTD was not reached in the entire cohort nor in TN and RR subgroups (Figure 1A). The 12-month discontinuation rate was 10.6% overall (9.3% TN, 12.8% RR). Overall, 7.6% (30/393) of patients (18 TN, 12 RR) discontinued treatment. Main reasons were toxicity (15 pts) and disease progression (10 pts). Patients with a Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS) >3 had a significantly higher probability of discontinuating therapy (12-month discontinuation rate CFS < or =3 vs CFS>3: 6.2% vs 22.3%, P<0.0001) (Figure 1B), while IGHV status and TP53 disruption did not significantly impact on TTD. The 12-month TTNTD probability was 94.6% overall (95.8 % TN, and 92.5% RR). This preliminary report from the largest available real-world study on zanubrutinib in CLL confirms a favorable safety profile in both TN and RR settings, with a low rate of discontinuation.

SHILAP Revista de lepidopterología
Università Cattolica del Sacro Cuore (IT), University of Pisa (IT), University of Rome Tor Vergata (IT), University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Molise (IT), University of Padua (IT), University of Trieste (IT), Magna International (Germany) (DE), University of Perugia (IT), Azienda Ospedaliera San Giovanni Addolorata (IT), Cardinal Health (Australia) (AU), Association for Symbolic Logic (US), Ospedale di Circolo e Fondazione Macchi (IT), CTO Hospital (IT), Agostino Gemelli University Polyclinic (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Institute for Stem Cell Biology and Regenerative Medicine (IN), Azienda Sanitaria Unità Locale di Reggio Emilia (IT), Ospedale degli Infermi (IT), Centro di Riferimento Oncologico della Basilicata (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), The Dia Foundation for Research on Ageing Societies (JP), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Azienda ospedaliera "Bianchi-Melacrino-Morelli" (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Ospedale di Santo Spirito (IT), Fatebenefratelli Hospital (IT), Azienda Ospedaliero-Universitaria di Modena (IT), Department of Health (ES), Azienda Ospedaliera S.Giuseppe Moscati (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Ospedale Santa Maria (IT), Federico II University Hospital (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), Azienda Ospedaliera Sant'Andrea (IT), Centro di Riferimento Oncologico (IT), Policlinico Universitario di Catania (IT), Istituto Tumori Bari (IT), Nini Hospital (LB), Stem Cell Institute (PA), Guglielmo da Saliceto Hospital (IT), Ospedale Santa Maria Goretti (IT), Campus Bio Medico University Hospital (IT), Azienda di Rilievo Nazionale ed Alta Specializzazione (IT), Ospedale Sant'Anna (IT), Ospedale SS. Annunziata (IT), Policlinico San Matteo Fondazione (IT), Ospedale San Bortolo (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Fondazione Vincenzo Pansadoro (IT), Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo (IT), Ospedale Civile di Venezia (IT), La Maddalena (IT), Azienda Sanitaria Universitaria Integrata di Trieste (IT), Azienda Ospedaliera Universitaria Pisana (IT), Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte (IT), Azienda Ospedaliera G. Brotzu (IT), European Institute of Oncology (IT), Sapienza University of Rome (IT)
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Medical History and Research
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