Meletios A. Dimopoulos, MD, discusses the goal of the phase 3 ASPEN trial in Waldenström macroglobulinemia.
Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University Athens School of Medicine, discusses the goal of the phase 3 ASPEN trial in Waldenström macroglobulinemia.
In an effort to demonstrate that a novel BTK inhibitor may be more advantageous than ibrutinib (Imbruvica), investigators designed the randomized ASPEN study, says Dimopoulos.
Waldenström macroglobulinemia is a rare disease. As such, few prospective, randomized trials have been performed within the space to date, explains Dimopoulos. The primary end point of the ASPEN trial was to see whether the administration of zanubrutinib (Brukinsa) could result in a superior complete response rate and very good partial response rates compared with ibrutinib.
Furthermore, patients were evaluated for an MYD88 mutation, which is known to present in the majority of patients with Waldenström macroglobulinemia,; those with the MYD88 mutation were eligible for inclusion in the study, concludes Dimopoulos.