On March 7, 2024, the Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib, marketed as Brukinsa by BeiGene USA, Inc., for the treatment of relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.
Study Background: ROSEWOOD Trial (BGB-3111-212)
The approval was based on findings from Study BGB-3111-212, also known as the ROSEWOOD trial (NCT03332017). This open-label, multicenter, randomized trial enrolled 217 adult patients with relapsed or refractory FL after at least two prior systemic treatments. Patients were randomized in a 2:1 ratio to receive either zanubrutinib 160 mg orally twice daily in combination with obinutuzumab (ZO), or obinutuzumab alone.
[VIDEO] Constantine Tam, MD discusses Zanubrutinib in combination with Sonrotoclax at ASH 2023
Efficacy Results
The efficacy of the zanubrutinib and obinutuzumab combination was assessed based on the overall response rate (ORR) and duration of response (DOR) as determined by an independent review committee. The ORR was significantly higher in the ZO arm at 69% compared to 46% in the obinutuzumab monotherapy arm (p-value: 0.0012). Additionally, the median DOR was not reached in the ZO arm, with an estimated DOR rate of 69% at 18 months.
Safety Profile
Common adverse reactions (≥30%) observed in patients receiving zanubrutinib included decreased neutrophil counts (51%), decreased platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Serious adverse reactions occurred in 35% of FL patients treated with ZO.
Dosage and Administration
The recommended dosage of zanubrutinib is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.
Conclusion
The accelerated approval of zanubrutinib in combination with obinutuzumab offers a promising treatment option for patients with relapsed or refractory follicular lymphoma following multiple lines of therapy. Further studies are ongoing to confirm the clinical benefit of this combination regimen.
Reference Links:
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
OncologyTube Links: https://oncologytube.com/sonrotoclax-zanubrutinib-welltolerated-deep-responses-tn-cll-sll-ash-2023/