BRUKINSA is now reimbursed across the UK for R/R MZL

BRUKINSA is the only BTK inhibitor recommended by NICE and accepted by SMC for adults with MZL who have received at least one prior anti-CD20-based therapy.^​1–5​

MZL is an indolent B-cell lymphoma with heterogeneous clinical presentation^​6–8​

The World Health Organization classifies MZL into three subtypes: extranodal, splenic, and nodal.^​6,7​ MZL is linked to chronic inflammation and is associated with multiple infectious agents and autoimmune diseases.^​​7,8​ The heterogeneity of MZL can make treatment decisions challenging, needing a tailored approach based on the characteristics of the patient and disease subtype.^​​7,8​

While many patients achieve long remissions following initial therapy, relapse is common, especially among patients with advanced disease at diagnosis.^​​6​ Those who experience disease progression within 24 months of initial therapy have a median survival of only 3 to 5 years.^​7​ Patients are typically older adults and many have co-morbidities leading to unacceptable toxicities with chemotherapy.^​6,7​

BRUKINSA is a next-generation BTK inhibitor that has demonstrated efficacy in R/R MZL, across the subtypes.^​9​​ It is an oral, targeted treatment that has been well-tolerated in patients with R/R MZL and other B-cell malignancies across clinical studies.^​1,9​

BRUKINSA is reimbursed and available for eligible patients in the UK^​​3,4​

SMC has announced that BRUKINSA is accepted for reimbursement within NHS Scotland, making it available to patients with R/R MZL across the UK.^​3,4​

SMC acceptance for Scotland, December 2024

BRUKINSA monotherapy is accepted by SMC for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.^​​3​

This advice applies only in the context of an approved NHS Scotland 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 lower.^​​3​

See more about BRUKINSA reimbursement in Scotland.

NICE recommendation for England and Wales, September 2024

The National Institute for Health and Care Excellence (NICE) recommends BRUKINSA as an option for treating marginal zone lymphoma in adults who have had at least 1 anti‑CD20-based treatment.^​​4​

It is only recommended if the company provides it according to the commercial arrangement.^​​4​

See more about BRUKINSA reimbursement in England and Wales.

BRUKINSA demonstrated deep and sustained responses across R/R MZL subtypes in the MAGNOLIA clinical study^​9​

MAGNOLIA specifically evaluated BRUKINSA in patients with R/R MZL who have relatively limited treatment options^​6,9​

MAGNOLIA was an open-label, single-arm Phase 2 study evaluating the efficacy and safety of BRUKINSA for the treatment of patients with R/R MZL who had received at least 1 anti-CD20–directed regimen. Eligible patients (N=68) were treated with BRUKINSA 160mg twice daily until disease progression, unacceptable toxicity, withdrawal of consent or the end of the study.^​9​

MAGNOLIA evaluated a range of patients with R/R MZL, including patients with extranodal (n=26), nodal (n=26) and splenic (n=12) disease (4 patients had unknown subtype).^​1,9​

The primary efficacy endpoint was IRC-assessed ORR, defined as the proportion of patients who achieved a best overall response of partial response or complete response. Secondary efficacy endpoints included investigator-assessed ORR, DoR, PFS and OS.^​9​

BRUKINSA showed high response rates in R/R MZL, with a median response time of 2.8 months (range: 1.7, 11.1)^​1,9​

Adapted from Opat S, et al. 2023⁹

BRUKINSA achieved deep and sustained responses, regardless of MZL subtype^​9​

Adapted from Opat S, et al. 2023⁹

Response rates were consistent across pre-specified subgroups, including patients traditionally considered difficult to treat, such as those with advanced age and advanced-stage MZL.^​9​

BRUKINSA demonstrated durable disease control in R/R MZL^​9​

At 24 months, the PFS rate was 70.9% (95% CI: 57.2, 81.0) and the DoR rate was 72.9% (95% CI: 54.4, 84.9). At the last analysis, patients were still responding well, with neither the median PFS or DoR reached (at a median follow-up of 27.4 and 23.4 months, respectively).^​9​

Adapted from Opat S, et al. 2023⁹

BRUKINSA was generally well tolerated, with no new safety signals observed^†​9​

The most common Grade ≥3 AEs were neutropenia (8.8%) and COVID-19 (5.9%). BRUKINSA had low rates of AEs of special interest, including hypertension (any Grade: 4.4%; Grade ≥3: 2.9%) and atrial fibrillation/flutter (any Grade: 2.9%; Grade ≥3: 1.5%).^† No cardiac AEs led to treatment discontinuation.^​9​

Overall, BRUKINSA had a favourable safety profile in patients with R/R MZL, with low rates of dose interruptions, dose reductions and discontinuations due to AEs.^​9​

Beigene

BRUKINSA’s favourable safety profile is well documented and consistent across indications^​1​

In pooled safety data from 1550 patients with B-cell malignancies (median duration of treatment exposure: 34.41 months), the most commonly occurring adverse reactions (≥20%) were upper respiratory tract infection (36%), bruising (32%), haemorrhage/haematoma (30%), neutropenia (30%), musculoskeletal pain (27%), rash (25%), pneumonia (24%), diarrhoea (21%) and cough (21%).^​1​

Of the 1550 patients treated with BRUKINSA, adverse reactions leading to dose reduction and treatment discontinuation occurred in 5.0% and 4.8% of patients, respectively. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (2.6%).^​1​

Refer to the BRUKINSA SmPC for complete safety information.

BRUKINSA is an oral therapy with flexible and convenient dosing^​1​

• Treatment with BRUKINSA offers once-daily or twice-daily dosing options.^​1​
• BRUKINSA can be co-administered with PPIs and H2RAs without compromising efficacy and can be dose-adjusted for patients who are taking moderate and strong CYP3A inhibitors.^​1​
• No specific dose adjustment is required for elderly patients (≥65 years old) taking BRUKINSA.^​1​

Refer to the BRUKINSA SmPC for complete information before initiating therapy with BRUKINSA.

Click here for BRUKINSA prescribing information

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Report any suspected adverse reactions.

Footnotes

*Two patients in MAGNOLIA (N=68) were not evaluated for efficacy due to central confirmation of MZL transformation to diffuse large B-cell lymphoma but were included for safety evaluation.^​1​
†Five patients died due to AEs: COVID-19 pneumonia (n=2); myocardial infarction in a patient with preexisting cardiovascular disease (n=1); acute myeloid leukemia in a patient with prior exposure to an alkylating agent (n=1); septic encephalopathy following radical cystectomy and ileal conduit in a patient with recurrent bladder cancer (n=1).^​9​
‡1 patient experienced atrial fibrillation and 1 patient experienced atrial flutter. Atrial fibrillation occurred 21 days after the last dose of BRUKINSA in a patient with a history of atrial fibrillation.^​9​

Abbreviations

AE, adverse event; BTK, Bruton’s tyrosine kinase; CI, confidence interval; COVID-19, coronavirus disease 2019; CR, complete response; DoR, duration of response; H2RA, histamine H2-receptor antagonist; IRC, independent review committee; MZL, marginal zone lymphoma; NICE, National Institute for Health and Care Excellence; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PPI, proton-pump inhibitor; PR, partial response; R/R, relapsed or refractory; SMC, Scottish Medicines Consortium; SmPC, Summary of Product Characteristics.

1124-BRU-PRC-145 | December 2024