C013 | an Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program – Zanos Study
Year: 2025
Type: article
Abstract: The primary analysis of MAGNOLIA, which led to drug approval, demonstrated that the next-generation BTK inhibitor zanubrutinib provided a high overall response rate (ORR) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL), with a favorable safety/tolerability profile. Zanubrutinib demonstrated a durable disease control during the 2-year follow-up. Nevertheless, real-life studies provide additional information on drug’s safety and effectiveness, ensuring more detailed monitoring of toxicity and adverse events (AEs). We conducted an Italian multicenter study in order to investigate the therapeutic potential and safety profile of zanubrutinib between January 2021 and October 2023 in a real-world context, we conducted a retrospective study across multiple centers in Italy (N = 25), within the framework of the named patient program (NPP, between January 2021 and October 2023). Forty-five patients were enrolled (17 nodal, 8 extranodal and 20 splenic MZL respectively), 64.4% of whom refractory to the last therapy, 35.6% with B symptoms and 22.2% with and ECOG PS of 2/3. After a median of 13 cycles the ORR resulted 48.9%, with a complete response rate of 48.9 rate. Median duration of response (DoR) was reached at 14.3, median progression free survival (PFS) at 14.6 and media overall survival (OS) was not reached at a median follow-up of 17.7 months. At one year estimated PFS was 60% and DoR 70%, respectively. No drug-related deaths occurred. Nine patients received subsequent therapy. In the MAGNOLIA study The ORR by investigator assessment was 74.2% (higher than present study), whereas the CR rate was 25.8% (lower than the present study). The IRC-assessed DOR rate at 12 months was 93.0%, and IRC-assessed PFS rate was 82.5%. Regarding treatment-emergent AEs (TEAE), 13 patients had hematologic toxicities, 9 of which were grade ≥3 and 18 patients reported five extra-hematological grade ≥3 TEAEs. However, all TEAEs rapidly resolved and were easily managed, treatment was well tolerated with the majority of AEs being grade 1 or 2 like in the MAGNOLIA study. Considering that this real-world population had more high-risk baseline characteristics than the one of the Magnolia study, our results of are consistent with prospective studies highlighting the effectiveness and safety of zanubrutinib in MZL.
Authors: V. Stefoni, A. Broccoli, L. Argnani, S. Blandino, F. Forte, G. Catania, V. Usai, V. Innao, A. Figuera, E. Martino, G. Daghia, B. Puccini, F. Malaspina, G. Lolli, M. Deodato, G. Scalpinello, D. Marino, M. Musso, M. Porrazzo, M. Cimminiello, M. Nizzoli, V. Rapisarda, L. Petrucci, C. Vitale, E. Lucchini, R. Plos, I. Ferrarini, S. Usai, P.L. Zinzani
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093122007
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