European Commission approval for Brukinsa for the treatment of adults with chronic lymphocytic leukemia

The EC approval is based on positive results from two Phase III clinical trials: SEQUOIA (NCT03336333), in patients with previously untreated CLL, and ALPINE (NCT03734016), 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% vs 72.9% (p=0.0264). Additionally, more Brukinsa patients than ibrutinib patients had a sustained response at 1 year with rates of 90% vs 78%. 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.

Prof. Clemens Wendtner, Head of Hematology and Oncology at Munich Clinic, an academic teaching hospital of the University of Munich, Germany, commented, “Brukinsa has demonstrated clinically meaningful improvements as a next-generation BTKi over the first generation BTKi, and is proven to be significantly more effective and tolerable. Ensuring medicines are safe and tolerable for this patient population is critical, given the long-term treatment needed for CLL. Combined with the flexible dosing options, this approval offers a practice-changing option for patients with CLL, one of the most common types of leukemia in adults.