P109 | A MULTICENTER RETROSPECTIVE ANALYSIS OF ZANUBRUTINIB THERAPY IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ("PARTENOPE PROJECT"): REPORT FROM THE CAMPANIA NETWORK ON CHRONIC LYMPHOCYTIC LEUKEMIA

Zanubrutinib, a selective second-generation covalent Bruton tyrosine kinase inhibitor approved in various B-cell malignancies, has showed its activity in B-cell chronic lymphocytic leukemia (CLL). Here we report the preliminary data of a multicenter experience on therapy with zanubrutinib in de novo (TN) and relapsed/refractory (R/R) CLL patients in light of the "Pathways of cAmpania netwoRk for the harmonizaTion of thErapeutic and maNagement approach in chrOnic lymPhocytic leukEmia (PARTENOPE)" project. Thyrty-eight patients with CLL were retrospectively evaluated (M 26; F 12; mean age 71 years; range 48-92 years); 24 patients with TN (M 17; F 7; mean age 72,1 years; range 48 -92 years) and 14 patients with R/R CLL (M 9; F 5; mean age 69,3 years; range 52-73 years). IgVH was tested in 25 patients (mutated IgVH was found in 6 TN patients and in 5 R/R patients) and p53 in 27 patients (mutated in 3 TN patients and 2 R/R patients, respectively) before starting treatment with zanubrutinib. The patients were treated at our Institutions (Campania Regione, Southern Italy) with zanubrutinib (Brukinsa) 160 mg twice daily between Novembre 29th, 2023 and 15th April, 2025. All R/R CLL patients received only one line of therapy before Zanubrutinib. Previously given therapy were rituximab, fludarabine and cyclophosphamide regimen (R-FluCy), rituximab and Bendamustine regimen (R-Benda), and chlorambucil in monotherapy. Hypertension was observed as the most frequent comorbidity (16 patients: 12,5%), followed by diabetes (4 patients) and chronic ischemic hearth disease (3 patients) at baseline. Only 9 patients (23,6%) showed adverse side effects, mainly ecchymoses (7 patients). One case with conjunctival hemorrhage and 1 case with atrial fibrillation were the cause of definitive zanubrutinib discontinuation (all patients were R/R CLL with previously diagnosed hypertension and chronic ischemic hearth disease). All in all, at 30th April, 2025, 30 patients were evaluable for response. An overall response rate of 68% was observed: 7 complete response (CR) and 11 partial response (PR) in TN CLL patients, 7 CR, 1 PR and 4 stable disease in R/R patients. In this preliminary analysis, despite limited in number and with a short median follow-up (less than 15 months), zanubrutinib demonstrated in our hands also high response rates with acceptable toxicity confirming as a valuable treatment option for both naive and R/R patients with CLL.