BRUKINSA® Data at ASCO Highlights Distinct Clinical Profile for CLL and SLL Treatment

BeiGene, Ltd., a global oncology firm, has unveiled new analyses highlighting the efficacy and safety of its drug BRUKINSA® (zanubrutinib) in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 31 to June 4, 2024.

Network Meta-Analysis: Superior Progression-Free Survival

A network meta-analysis examined data from three randomized controlled trials—ALPINE, ELEVATE-RR, and ASCEND—focusing on high-risk relapsed/refractory (R/R) CLL patients. The study found that BRUKINSA provided a statistically significant improvement in progression-free survival (PFS) compared to acalabrutinib. Additionally, there was a trend indicating better overall survival (OS), overall response rate (ORR), and complete response rate (CR) with BRUKINSA. Against ibrutinib and the combination of bendamustine + rituximab or idelalisib + rituximab, BRUKINSA also showed significant PFS benefits and trends towards improved OS.

Lead researcher, Dr. Mazyar Shadman from Fred Hutch Cancer Center and University of Washington, emphasized the significance of these findings, noting that BRUKINSA appears to delay disease progression more effectively than other BTK inhibitors analyzed.

Effectiveness and Tolerability in Kaiser Permanente Database

In a retrospective analysis of the Kaiser Permanente Northern California database, the efficacy and safety of BRUKINSA were assessed among 281 CLL/SLL patients. Out of these, 190 had switched from ibrutinib to BRUKINSA, and 91 were treated exclusively with BRUKINSA. The follow-up periods were 24.4 and 8.2 months, respectively. The analysis revealed that BRUKINSA had similar treatment-emergent adverse event (TEAE) rates compared to ibrutinib but demonstrated lower treatment-limiting adverse event (TLAE) rates. Notably, cardiac-related adverse events were more prevalent with ibrutinib, and their frequency decreased after switching to BRUKINSA. Importantly, no treatment-related deaths were reported.

Reduced Need for Antihypertensives

A post-hoc analysis of the ALPINE trial data investigated the initiation of antihypertensive medications in CLL/SLL patients treated with either BRUKINSA or ibrutinib. Results indicated that fewer patients on BRUKINSA required new antihypertensives or new classes of antihypertensives compared to those on ibrutinib. Additionally, the initiation of these medications occurred sooner in the ibrutinib group.

Clinical Implications and Future Directions

Dr. Mehrdad Mobasher, Chief Medical Officer of Hematology at BeiGene, suggested that these findings offer valuable insights for oncologists in making treatment decisions for CLL and SLL patients. The favorable PFS and lower necessity for antihypertensives with BRUKINSA underscore its potential as a preferred BTK inhibitor in clinical practice.

About BRUKINSA

BRUKINSA is designed to inhibit the BTK protein effectively, with optimized bioavailability, half-life, and selectivity. It has shown efficacy in multiple disease-relevant tissues.

Safety Information

While BRUKINSA has shown remarkable efficacy, it also carries risks including hemorrhage, infections, cytopenias, second primary malignancies, and cardiac arrhythmias. It's crucial for healthcare providers to monitor patients for these potential adverse effects.

Conclusion

The new analyses presented at the ASCO Annual Meeting reinforce BRUKINSA's standing as a potent and generally well-tolerated therapy for CLL and SLL. These findings are instrumental for oncologists seeking effective treatment options for high-risk patients, potentially shifting clinical practice towards greater adoption of BRUKINSA.

These results are hypothesis-generating and should be interpreted in the context of the limitations of the meta-analysis and existing clinical trials. Further confirmatory studies are warranted to establish definitive conclusions.

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