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BMS Honoraria: Roche, Janssen, Gilead, AstraZenecca, Lilly, TG therapeutics, Beigene, Novartis, Menarini, Daizai, Abbvie, Genmab. B Introduction: b Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi, demonstrated efficacy in patients (pts) with CLL resistant to cBTKi. [Extracted from the article]

This unanchored MAIC estimates the treatment effect of pirtobrutinib (BRUIN) vs venetoclax continuous monotherapy in pts with R/R CLL treated with a cBTKi. MATCHING-ADJUSTED INDIRECT COMPARISON OF PIRTOBRUTINIB VS VENETOCLAX CONTINUOUS MONOTHERAPY IN PATIENTS WITH RELAPSED/REFRACTORY CLL TREATED WITH COVALENT BTK INHIBITOR B Introduction: b Venetoclax-based therapy is standard for pts with relapsed/refractory (R/R) CLL previously treated with a covalent BTK inhibitor (cBTKi). [Extracted from the article]

This interim analysis (IA) presents baseline demographics, clinical characteristics, and treatment patterns of patients with CLL up to 24 months post-initiation of first-line acalabrutinib via the UK Early Access Programme (EAP). EPIC: A NON-INTERVENTIONAL, OBSERVATIONAL UK STUDY OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) PATIENTS TREATED WITH FIRST-LINE ACALABRUTINIB. Eligible patients were treatment-naïve CLL patients who initiated acalabrutinib between 1 SP st sp April 2020 and 1 SP st sp April 2021 as part of the EAP and were recruited from 5 sites in England for this IA. [Extracted from the article]

BACKGROUND: Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) have poor outcomes after the failure of covalent Bruton's tyrosine kinase (BTK) inhibitor treatment, and new therapeutic options are needed. Pirtobrutinib, a highly selective, noncovalent (reversible) BTK inhibitor, was designed to reestablish BTK inhibition. METHODS: We conducted a phase 1-2 trial in which patients with relapsed or refractory B-cell cancers received pirtobrutinib. Here, we report efficacy results among patients with CLL or SLL who had previously received a BTK inhibitor as well as safety results among all the patients with CLL or SLL. The primary end point was an overall response (partial response or better) as assessed by independent review. Secondary end points included progression-free survival and safety. RESULTS: A total of 317 patients with CLL or SLL received pirtobrutinib, including 247 who had previously received a BTK inhibitor. Among these 247 patients, the median number of previous lines of therapy was 3 (range, 1 to 11), and 100 patients (40.5%) had also received a B-cell lymphoma 2 (BCL2) inhibitor such as venetoclax. The percentage of patients with an overall response to pirtobrutinib was 73.3% (95% confidence interval [CI], 67.3 to 78.7), and the percentage was 82.2% (95% CI, 76.8 to 86.7) when partial response with lymphocytosis was included. The median progression-free survival was 19.6 months (95% CI, 16.9 to 22.1). Among all 317 patients with CLL or SLL who received pirtobrutinib, the most common adverse events were infections (in 71.0%), bleeding (in 42.6%), and neutropenia (in 32.5%). At a median duration of treatment of 16.5 months (range, 0.2 to 39.9), some adverse events that are typically associated with BTK inhibitors occurred relatively infrequently, including hypertension (in 14.2% of patients), atrial fibrillation or flutter (in 3.8%), and major hemorrhage (in 2.2%). Only 9 of 317 patients (2.8%) discontinued pirtobrutinib owing to a treatment-related adverse event. CONCLUSIONS In this trial, pirtobrutinib showed efficacy in patients with heavily pr'etreated CLL or SLL who had received a covalent BTK inhibitor. The most common adverse events were infections, bleeding, and neutropenia. (Funded by Loxo Oncology; BRUIN ClinicalTrials.gov number, NCT03740529). [ABSTRACT FROM AUTHOR]