Relapsed or refractory CLL - Brukinsa®▼ (zanubrutinib)

NICE recommends BRUKINSA as an option for treating adult patients with CLL that is:³

Untreated and there is a 17p deletion or TP53 mutation, or
Untreated, there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab, or bendamustine plus rituximab is unsuitable, or
Relapsed or refractory

It is recommended only if the company provides it according to the commercial arrangement³

BRUKINSA monotherapy is accepted by SMC as an option for treating adults with CLL:⁴

In whom chemo-immunotherapy is unsuitable.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower⁴

BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy both vs CIT in TN CLL and vs ibrutinib in R/R CLL^1,5–10

Select one of the two options below:

Treatment-naïve CLL Relapsed or refractory CLL

Median follow-up 29.6 months

Primary endpoint: investigator-assessed ORR⁷

80%

BRUKINSA

71%

ibrutinib

superiority two-sided p=0.0133

Key secondary endpoint: PFS vs ibrutinib⁷

HR=0.65

(95% CI, 0.49, 0.86); p=0.0024

Higher and deeper responses with superior PFS
compared to ibrutinib in R/R CLL¹³

Investigator assessed; median follow-up: 42.5 months

PFS vs ibrutinib

HR=0.68

(95% CI: 0.54, 0.84)

Long-term follow-up: 48-month ORR

Investigator-assessed; median follow-up 42.5 months

Adapted from Brown, et al. 2024.¹³

PFS in patients with del(17p),
TP53 mutation or both vs ibrutinib

Investigator assessed; median follow-up: 42.5 months

HR=0.51

(95% CI: 0.33, 0.78)

Adapted from Brown, et al. 2024.¹³

Overall median follow-up: 42.5 months

Atrial fibrillation

7%

BRUKINSA
(n=23/324)

17%

ibrutinib
(n=55/324)

Treatment discontinuation due to cardiac AEs

1%

BRUKINSA
(n=3/324)

5%

ibrutinib
(n=16/324)

Treatment discontinuation due to AEs

Overall median follow-up: 42.5 months

20%

BRUKINSA
(n=65/324)

28%

ibrutinib
(n=89/324)