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SEQUOIA 5-year follow-up: Zanubrutinib vs bendamustine + rituximab in patients with treatment-naïve CLL/SLL
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BTKis are among the preferred treatment options for patients with CLL/SLL, offering improved PFS vs chemoimmunotherapy regimens.1 However, data for outcomes with longer-term BTKi exposure are limited and are important in establishing the role of BTKis in the treatment of CLL/SLL.1 SEQUOIA (NCT03336333) is an open-label, randomized, controlled, phase III trial evaluating the efficacy and safety of zanubrutinib vs bendamustine (B) plus rituximab (R) in patients with TN CLL.1 The 5-year follow-up results from the trial were published in the Journal of Clinical Oncology by Shadman et al.1 (N = 497; zanubrutinib n = 241; BR n =238). |
| Key learnings |
| The median follow-up was 61.2 months. The median PFS was NR for patients receiving zanubrutinib vs 44.1 months with BR (HR, 0.29; 95% CI, 0.21–0.40; p < 0.0001), with estimated 60-month PFS rates of 75.8% vs 40.1%. |
| The median OS was not reached in either treatment arm. Estimated 60-month OS rates were 85.8% vs 85.0% in patients receiving zanubrutinib vs BR. |
| No new safety signals were detected. TEAEs of interest with zanubrutinib vs BR included any-grade infections (79.6% vs 65.6%), bleeding (52.1% vs 13.2%), hypertension (22.9% vs 13.7%), neutropenia (17.1% vs 56.8%) anemia (9.6% vs 21.1%), thrombocytopenia (7.1% vs 18.5%), and atrial fibrillation/flutter (7.1% vs 3.5%). |
| Overall, the long-term efficacy and safety data from the SEQUOIA trial suggest that zanubrutinib could offer a favorable treatment option for patients with TN CLL. |
Abbreviations: B, bendamustine; BTKi, Bruton’s tyrosine kinase inhibitor; CI, confidence interval; CLL, chronic lymphocytic leukemia; HR, hazard ratio; NR, not reached; OS, overall survival; PFS, progression-free survival; R, rituximab; SLL, small lymphocytic lymphoma; TEAE, treatment-emergent adverse event; TN, treatment-naïve.
Shadman M, Munir T, Robak T, et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: Median 5-year follow-up of SEQUOIA. J Clin Oncol. 2024. Online ahead of print. DOI: 10.1200/JCO-24-0226
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