American journal of cancer research · 2026
Efficacy and safety analysis of a novel BTK inhibitor in patients with mantle cell lymphoma harboring TP53 mutations.
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Liu Min, Ding Yannong, Lan Hui
Аннотация
OBJECTIVE: To rigorously evaluate the efficacy and safety of a novel Bruton tyrosine kinase inhibitor (BTKi), alone or in combination with venetoclax, in patients with TP53-mutated mantle cell lymphoma (MCL), focusing on survival outcomes, depth of response, minimal residual disease (MRD), clearance, and treatment-emergent toxicities.
METHODS: We conducted a retrospective, observational cohort study of consecutive adults with TP53-mutated MCL treated with BTKi-based regimens between January 2022 and December 2025. Patients were assigned to BTKi monotherapy (ibrutinib or acalabrutinib; n = 108) or BTKi plus venetoclax (n = 112). Clinical, pathological, and genomic data were recorded using standardized electronic case-report forms. Responses were assessed according to contemporary MCL criteria, and recurrence/progression-free survival (RFS/PFS) and overall survival (OS) were calculated from predefined time points.
RESULTS: Combined treatment significantly prolonged median RFS from 11 to 34 months (HR for recurrence or death 0.42, 95% CI 0.29-0.61; P<0.001), and median OS from 20 to 50 months (HR 0.44, 95% CI 0.31-0.63; P<0.001). Overall response rates were higher with BTKi-based combination therapy (76.8% vs. 58.3%; P = 0.001), with comparable rates of complete response. In multivariable models, BTKi-based combination therapy remained independently associated with longer PFS (HR 0.187, 95% CI 0.079-0.442; P<0.001).
CONCLUSION: In patients with TP53-mutated MCL, BTKi-based combination therapy confers clinically meaningful and durable improvements in RFS and OS, with higher overall response rates than monotherapy and acceptable toxicity profiles.
METHODS: We conducted a retrospective, observational cohort study of consecutive adults with TP53-mutated MCL treated with BTKi-based regimens between January 2022 and December 2025. Patients were assigned to BTKi monotherapy (ibrutinib or acalabrutinib; n = 108) or BTKi plus venetoclax (n = 112). Clinical, pathological, and genomic data were recorded using standardized electronic case-report forms. Responses were assessed according to contemporary MCL criteria, and recurrence/progression-free survival (RFS/PFS) and overall survival (OS) were calculated from predefined time points.
RESULTS: Combined treatment significantly prolonged median RFS from 11 to 34 months (HR for recurrence or death 0.42, 95% CI 0.29-0.61; P<0.001), and median OS from 20 to 50 months (HR 0.44, 95% CI 0.31-0.63; P<0.001). Overall response rates were higher with BTKi-based combination therapy (76.8% vs. 58.3%; P = 0.001), with comparable rates of complete response. In multivariable models, BTKi-based combination therapy remained independently associated with longer PFS (HR 0.187, 95% CI 0.079-0.442; P<0.001).
CONCLUSION: In patients with TP53-mutated MCL, BTKi-based combination therapy confers clinically meaningful and durable improvements in RFS and OS, with higher overall response rates than monotherapy and acceptable toxicity profiles.