Search

Zanubrutinib – FDA Approval, Efficacy & Safety Profile – Discussion with Dr. Shadman


17.jpg

In this episode of the Oncology Brothers podcast, we had the privilege of discussing the groundbreaking studies Sequoia and Alpine with Dr. Mazyar Shadman from Fred Hutch Cancer Center. The focus was on the approval of Zanubrutinib in CLL based on these trials.
The Sequoia trial, a study in first-line CLL, demonstrated the superiority of Zanubrutinib over bendamustine or rituximab in terms of progression-free survival. Notably, Zanubrutinib showed benefit across all molecular subtypes, making it a promising option for frontline therapy.

Key Points:

  • The Sequoia trial demonstrated Zanubrutinib's superiority over bendamustine or rituximab for progression-free survival in first-line CLL across all molecular subtypes.
  • The Alpine study showed Zanubrutinib's superiority over ibrutinib in relapsed/refractory CLL, with better progression-free survival and a favorable safety profile.
  • A match-adjusted comparison between Acalabrutinib and Zanubrutinib highlights the complexities of indirect trial analyses and the need for cautious interpretation.
  • Monitoring and managing common side effects, such as bleeding and cardiac toxicity, is essential when using BTK inhibitors like Zanubrutinib.

On the other hand, the Alpine study, conducted in relapsed or refractory settings, compared Zanubrutinib to ibrutinib. The results showed that Zanubrutinib was superior to ibrutinib for progression-free survival, even in high-risk populations. The safety profile of Zanubrutinib was also favorable, with lower rates of atrial fibrillation compared to ibrutinib.
Dr. Shadman also discussed a match-adjusted indirect trial comparison between Acalabrutinib and Zanubrutinib, highlighting the complexities of such analyses and the need for caution in interpreting results.
Furthermore, the podcast delved into the common side effects of BTK inhibitors, emphasizing the importance of monitoring and managing issues such as bleeding, infections, and cardiac toxicity.
Overall, the episode provided valuable insights into the evolving landscape of CLL treatment, showcasing the efficacy and safety of Zanubrutinib in both frontline and relapsed/refractory settings. Listeners were encouraged to stay tuned for more practice-changing data and conference highlights from the Oncology Brothers.