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Safety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study
Opat, S. S. Tedeschi, A. Hu, B. Linton, Kim M McKay, P. Leitch, S. Coleman, M. Zinzani, P. L. Jin, J. Sun, M.
Opat, S. S.
Tedeschi, A.
Hu, B.
Linton, Kim M
McKay, P.
Leitch, S.
Coleman, M.
Zinzani, P. L.
Jin, J.
Sun, M.
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Abstract
The primary analysis of MAGNOLIA, an open-label, single-arm, multicenter, phase 2 study, demonstrated that the next-generation Bruton tyrosine kinase 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. Presented here is the final analysis of MAGNOLIA, performed to characterize the durability of response and longer-term safety and tolerability. Zanubrutinib (160 mg twice daily) was evaluated in 68 patients with R/R MZL who had received at least 1 anti-CD20-directed regimen. The primary endpoint was independent review committee (IRC)-assessed ORR. Secondary endpoints included investigator-assessed ORR, duration of response (DOR), progression-free survival (PFS), overall survival (OS), health-related quality of life, safety, and tolerability. With a median follow-up of 27.4 months, the IRC-assessed ORR was 68.2% (95% confidence interval [CI], 55.6%-79.1%), with a 24-month DOR event-free rate of 72.9% (95% CI, 54.4%-84.9%). PFS and OS at 24 months were 70.9% (95% CI, 57.2%-81.0%) and 85.9% (95% CI, 74.7%-92.4%), respectively. The zanubrutinib safety profile was consistent with the primary analysis, with no new safety signals observed. Atrial fibrillation/flutter (n = 2 [2.9%]) and hypertension (n = 3 [4.4%]) were uncommon. Neutropenia (n = 8 [11.8%]) was the most common grade ≥3 adverse event. In this final analysis of MAGNOLIA, zanubrutinib demonstrated sustained clinical responses beyond 2 years, with 73% of responders alive and progression-free. Zanubrutinib continued to demonstrate a favorable safety/tolerability profile with the additional time on treatment.
Authors
Opat, S. S.
Tedeschi, A.
Hu, B.
Linton, Kim M
McKay, P.
Leitch, S.
Coleman, M.
Zinzani, P. L.
Jin, J.
Sun, M.
Sobieraj-Teague, M.
Browett, P. J.
Ke, X.
Thieblemont, C.
Ardeshna, K. M.
Bijou, F.
Walker, P. A.
Hawkes, E. A.
Ho, S. J.
Zhou, K.
Liang, Z.
Xu, J.
Tankersley, C.
Delarue, R.
Co, M.
Trotman, J.
Tedeschi, A.
Hu, B.
Linton, Kim M
McKay, P.
Leitch, S.
Coleman, M.
Zinzani, P. L.
Jin, J.
Sun, M.
Sobieraj-Teague, M.
Browett, P. J.
Ke, X.
Thieblemont, C.
Ardeshna, K. M.
Bijou, F.
Walker, P. A.
Hawkes, E. A.
Ho, S. J.
Zhou, K.
Liang, Z.
Xu, J.
Tankersley, C.
Delarue, R.
Co, M.
Trotman, J.
Affiliation
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Date
2023
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Article
Citation
Opat SS, Tedeschi A, Hu B, Linton KM, McKay P, Leitch S, et al. Safety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study. Blood advances. 2023 Sep 8. PubMed PMID: 37682792. Epub 2023/09/08. eng.