BRUKINSA Data Presented at ASCO Highlights Distinctive Clinical Efficacy for CLL and SLL Treatment

A global oncology company today announced the presentation of new analyses for BRUKINSA® (zanubrutinib) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4, 2024. These presentations underscore the efficacy and safety of BRUKINSA compared to other Bruton’s tyrosine kinase inhibitors (BTKis) for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, commented, “This year’s ASCO presentations continue to build our extensive evidence base demonstrating BRUKINSA’s uniquely differentiated clinical profile. These new analyses highlight improved progression-free survival (PFS) and response rates, along with low antihypertensive medication use, providing oncologists with valuable insights for treating CLL and SLL.”

BRUKINSA’s Efficacy and Response Rates for CLL Compared to Other BTKis

A network meta-analysis assessed the efficacy of various treatments for high-risk relapsed/refractory (R/R) CLL using data from the ALPINE, ELEVATE-RR, and ASCEND trials. This analysis revealed a statistically significant improvement in PFS for BRUKINSA over acalabrutinib in high-risk patients and trends toward better overall survival (OS), overall response rate (ORR), and complete response (CR). BRUKINSA also showed statistically significant improvements in PFS compared to ibrutinib and bendamustine + rituximab/idelalisib + rituximab (BR/IR).

Mazyar Shadman, M.D., M.P.H., Associate Professor at Fred Hutch Cancer Center and University of Washington, stated, “Given the absence of head-to-head trials comparing BTK inhibitors in high-risk R/R CLL patients, our network meta-analysis estimated the relative efficacy of available treatments. Zanubrutinib emerged as the most efficacious BTKi, significantly delaying disease progression and offering favorable responses compared to other BTKis, including acalabrutinib.”

BRUKINSA’s Tolerability and Safety in Patients with Prior Ibrutinib Use

A retrospective analysis examined treatment patterns, treatment-emergent adverse events (TEAEs), treatment-limiting adverse events (TLAEs), and treatment-related mortality among CLL/SLL patients treated at Kaiser Permanente Northern California. Among 281 patients, 190 had switched from ibrutinib to BRUKINSA, while 91 received only BRUKINSA. With median follow-ups of 24.4 and 8.2 months respectively, similar TEAE rates were observed with both therapies, but BRUKINSA had lower TLAE rates. Cardiac TLAEs and non-TLAEs were higher with ibrutinib, and these rates decreased after switching to BRUKINSA. No treatment-related deaths were reported.

Reduced Need for Antihypertensive Medications with BRUKINSA

A post-hoc analysis of the ALPINE trial data evaluated the risk of hypertension based on the initiation of antihypertensive medications in CLL/SLL patients treated with BRUKINSA versus ibrutinib. The analysis found that new antihypertensives or new classes of antihypertensives were initiated less frequently in the BRUKINSA arm compared to the ibrutinib arm. Additionally, antihypertensive medications were initiated sooner in patients treated with ibrutinib. These findings are important for evaluating the overall safety profile of BTKi treatments.

Upcoming Virtual Panel Discussion

BeiGene will sponsor a virtual panel discussion titled “Exploring the landscape of next-generation BTK inhibitors in blood cancers” at the Endpoints at #ASCO24 event on June 4 from 12:35 – 1:05 p.m. ET, featuring leading hematology/oncology experts discussing BTKi treatment evolution and considerations for CLL therapy.

For more information about BeiGene’s activities at the 2024 ASCO Annual Meeting, please visit their newsroom meeting hub.

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed for complete and sustained inhibition of the BTK protein. It is approved for the treatment of various hematological malignancies, including CLL/SLL, Waldenström’s macroglobulinemia, mantle cell lymphoma, and others. The drug’s differentiated pharmacokinetics and proven efficacy make it a significant treatment option in these diseases.

Important Safety Information

Warnings and Precautions:

  • Hemorrhage: Serious hemorrhage, including fatal cases, has occurred. Monitor for signs of bleeding and discontinue if intracranial hemorrhage occurs.
  • Infections: Fatal and serious infections, including opportunistic infections, have been reported. Prophylaxis and monitoring for signs of infection are advised.
  • Cytopenias: Regular monitoring of blood counts is necessary due to risks of neutropenia, thrombocytopenia, and anemia.
  • Second Primary Malignancies: Increased risk of non-skin carcinomas and other malignancies. Use sun protection and monitor for new malignancies.
  • Cardiac Arrhythmias: Serious arrhythmias have been reported. Monitor for cardiac symptoms and manage appropriately.
  • Embryo-Fetal Toxicity: Zanubrutinib can cause fetal harm. Advise against pregnancy during treatment and for one week after the last dose.

Adverse Reactions:

Common adverse reactions include decreased neutrophil and platelet counts, upper respiratory tract infections, hemorrhage, and musculoskeletal pain.

Drug Interactions:

  • CYP3A Inhibitors: Dose adjustments are necessary with strong or moderate CYP3A inhibitors.
  • CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers.

Specific Populations

Consult the full prescribing information for additional details on the safe and effective use of BRUKINSA.

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