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Clinical trials

overview

The efficacy and safety of BRUKINSA®▼ in patients with CLL was investigated in two phase 3 randomised studies, SEQUOIA and ALPINE.1–4 Additionally, long-term data have been generated from extended follow-up of the phase 3 ALPINE study.4

SEQUOIA

SEQUOIA (BGB-3111-304) was an international, phase 3, open-label, randomised study of BRUKINSA compared with bendamustine + rituximab (BR) in patients with previously untreated CLL.1,2

ALPINE

ALPINE (BGB-3111-305) was a randomised, multicentre, open-label, phase 3, active controlled study of BRUKINSA compared with ibrutinib in patients with relapsed/refractory (R/R) CLL, with over 3 years of follow up.1,3,4

Study 215

Study 215 was a phase 2, multicentre, open-label, single-arm trial of BRUKINSA in patients with previously treated B-cell lymphoma who have shown intolerance to prior BTK inhibitor treatment.5,6

Abbreviations: CLL, chronic lymphocytic leukaemia.

References

1. BRUKINSA Summary of Product Characteristics. 2024.

2. Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5.

3. Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388:319-32. doi: 10.1056/NEJMoa2211582.

4. Brown JR, et al. ASH annual meeting, December 9–12, 2023. Oral presentation 202.

5. Shadman M, et al. ICML, June 13–17, 2023. Poster 345.

6. Shadman M, et al. Lancet Haematol. 2023;10(1):e35–e45.

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