Zanubrutinib (brand name Brukinsa) has been granted marketing authorisation by the European Commission (EC) for use in combination with obinutuzumab for eligible patients with follicular lymphoma, its manufacturer BeiGene has announced.
This highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor is now approved for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior lines of systemic therapy.
The EC approval is based on positive results from the phase 2 ROSEWOOD study which looked at zanubrutinib plus obinutuzumab compared with the anti-CD20 monoclonal antibody obinutuzumab alone.
Some 217 patients with R/R follicular lymphoma who had received at least two prior lines of systemic therapy were included in the global, randomised, open-label study.
The primary endpoint was overall response rate (ORR) by independent central review. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival, and safety.
The researchers found the ORR to be 69.0% in the zanubrutinib plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (P = 0.0012), with a median follow-up of approximately 20 months.
Responses were durable with 18-month landmark DOR of 69.3% in the zanubrutinib combination arm. Additionally, the median PFS for patients treated in the combination arm was 28.0 months, compared to 10.4 months for patients treated with only obinutuzumab (HR: 0.50 [95% CI: 0.33, 0.75]; P = 0.0007).
Zanubrutinib plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.
Zanubrutinib a ‘practice-changing option’
Dr Pier Luigi Zinzani, full professor of haematology at the Institute of Haematology ‘Seràgnoli’, University of Bologna, Italy, said: ‘People living with follicular lymphoma often experience relapse and have poor responses to subsequent lines of therapy, making it imperative to improve outcomes.
‘The results from the ROSEWOOD trial demonstrated a significant clinical benefit of Brukinsa plus obinutuzumab for patients with relapsed or refractory follicular lymphoma. Brukinsa is a chemotherapy-free, oral treatment option that can be a practice-changing option for eligible patients with relapsed or refractory follicular lymphoma.’
This is the fourth approved indication for this drug in the EU, which gives it ‘the broadest label of any medicine in its class globally’, according to Mehrdad Mobasher, chief medical officer, hematology at BeiGene.
In addition to R/R follicular lymphoma, zanubrutinib is approved in the EU as monotherapy for the treatment of adult patients with: chronic lymphocytic leukaemia, marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, and Waldenström’s macroglobulinemia who have received at least one prior therapy, or in firstline treatment for patients unsuitable for chemo-immunotherapy.
The use of zanubrutinib in R/R follicular lymphoma is currently under review by regulatory authorities in Switzerland and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative.