European Commission Approves BeiGene’s Brukinsa for the Treatment of Adults with CLL

The European Commission approved BeiGene’s BTK inhibitor Brukinsa for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia, a slow-growing, life-threatening, and incurable cancer of adults.

“This approval represents an important milestone for CLL patients and their physicians who now have a new chemotherapy-free treatment option, and an alternative to current BTKi treatment options,” said Mehrdad Mobasher, chief medical officer, Hematology at BeiGene. “Given that Brukinsa has demonstrated consistent benefit across patient subgroups, regardless of risk status, we believe Brukinsa could now be the preferred treatment option for newly diagnosed and relapsed/refractory CLL patients.”

The EC approval is based on positive results from two phase 3 clinical trials: SEQUOIA p, in patients with previously untreated CLL, and ALPINE p, in patients with R/R CLL. In these two trials, Brukinsa demonstrated superior efficacy versus either bendamustine plus rituximab (B+R) or ibrutinib in first-line or R/R CLL, respectively. Brukinsa is the only BTKi to achieve superiority versus ibrutinib in R/R CLL, as assessed by independent review committee, with an overall response rate (ORR) of 80.4 percent vs 72.9 percent. Additionally, more Brukinsa patients than ibrutinib patients had a sustained response at 1 year with rates of 90 percent vs 78 percent. The adverse events within the two trials were consistent with the overall safety profile of Brukinsa. Subsequent to the regulatory submission, BeiGene announced topline results of the final PFS analysis of the head-to-head ALPINE trial, in which Brukinsa demonstrated superior PFS compared with ibrutinib in patients with R/R CLL.

Brukinsa is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Brukinsa was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

Brukinsa is currently approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy and adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

Photo: Mehrdad Mobasher, chief medical officer, Hematology at BeiGene

Author: Rare Daily Staff