On October 12, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that BRUKINSA (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator (Press release, BeiGene, OCT 12, 2022, View Source [SID1234621933]). BRUKINSA was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports.
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"This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "We look forward to sharing the full results with the medical and patient communities and will submit for presentation at a medical congress and for publication."
BeiGene’s supplemental New Drug Application for BRUKINSA for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) is currently under review with the FDA, with a target action date of January 20, 2023.
About ALPINE
ALPINE is a randomized, global Phase 3 trial (NCT03734016) comparing BRUKINSA against ibrutinib in previously treated patients with relapsed or refractory CLL or SLL. In the trial, a total of 652 patients across Europe (60%), the United States (17%), China (14%), New Zealand and Australia (9%) were randomized into two arms, with the first receiving BRUKINSA (160 mg orally twice daily) and the second receiving ibrutinib (420 mg orally once daily) until disease progression or unacceptable toxicity.
The primary endpoint of overall response rate (ORR), defined by pre-specified non-inferiority of BRUKINSA versus ibrutinib, was assessed by investigator and IRC using the modified 2008 iwCLL guidelines, with modification for treatment-related lymphocytosis for patients with CLL, and per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. There was pre-specified hierarchical testing of non-inferiority followed by superiority in ORR as assessed by investigator and IRC. Key secondary endpoints include PFS and event rate of atrial fibrillation or flutter; other secondary endpoints include duration of response, overall survival, and incidence of adverse events. In April 2022, BeiGene announced results from the final response analysis showing BRUKINSA demonstrated superiority versus ibrutinib in ORR as assessed by an IRC.
About BRUKINSA
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. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is supported by a broad clinical program, which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Great Britain, Switzerland, Canada, Australia, and additional international markets.