Positive CHMP opinion for Brukinsa for the treatment of adults with marginal zone lymphoma

“There are currently no BTK inhibitors approved for MZL in Europe and with this positive opinion, we are one step closer to bringing forward a chemotherapy-free treatment option for this rare blood cancer. We look forward to a decision from the European Commission in the coming months,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “We have undertaken a broad development program to evaluate Brukinsa as a potential treatment for various B-cell malignancies in over 4,500 patients, which continues to generate evidence to support Brukinsa as an effective and well-tolerated treatment option for blood cancer patients around the world.”

The CHMP recommendation is based on positive results from the Phase II, open-label, multicenter, single-arm MAGNOLIA trial (NCT03846427) in 66 patients with relapsed or refractory (R/R) MZL who received at least one anti-CD20-based regimen. In the study, the overall response rate (ORR) was 68% (95% CI: 55.6, 79.1) with 26% of patients achieving complete response (CR) and 42% achieving partial response (PR). The median time to response was 2.8 months (range: 1.7 to 11.1 months) and ORRs for MZL subtypes extranodal, nodal, splenic, and unknown were 64%, 76%, 67%, and 50%, respectively.

Brukinsa demonstrated favorable and well-defined tolerability consistent with its known safety profile. The most common ( greater than 30%) adverse reactions, including laboratory abnormalities, in the pooled safety population of 847 patients were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, and hemorrhage. The observed cardiac safety profile was consistent with previous Brukinsa studies, with low rates of atrial fibrillation (3%) and atrial flutter (0.4%). Brukinsa was well-tolerated, as demonstrated by low rates of discontinuation due to adverse events (6%).

Pier Luigi Zinzani, MD., PhD., Full Professor of Haematology at the Institute of Haematology “Seràgnoli”, University of Bologna, Italy commented, “Marginal zone lymphoma encompasses a number of subtypes. As a highly selective BTK inhibitor, the clinical trial data for Brukinsa showed deep and sustained overall responses regardless of subtype, along with a well-established safety profile. If approved, Brukinsa has the potential to deliver meaningful outcomes for MZL patients in Europe who otherwise have no approved treatment options.”