Dr Habermann on Ongoing Trials in MCL and MZL

Thomas M. Habermann, MD, consultant, Division of Hematology, Department of Internal Medicine, professor of medicine, Mayo Clinic, member, the Lymphoma Research Foundation’s Scientific Advisory Board, discusses ongoing clinical trials in mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). 

The formal publication of findings from the phase 3 TRIANGLE trial (NCT02858258) are anticipated, and data from the study presented at the 2022 ASH Annual Meeting could potentially be practice changing, Habermann says. The randomized trial evaluated ibrutinib (Imbruvica) plus induction chemotherapy with or without autologous stem cell transplant (ASCT) vs induction chemotherapy plus ASCT alone in younger patients with MCL. Findings showed that the 3-year failure-free survival (FFS) rate was 72% with standard induction and ASCT compared with 88% with ibrutinib added to induction, ASCT, and 2 years of ibrutinib maintenance (HR, 0.52; P = .0008). The 3-year FFS rate was 72% for chemoimmunotherapy/ASCT compared with 86% for ibrutinib alone (HR, 1.77; P = .9979).

Based on these outcomes, ibrutinib may replace ASCT as the new standard of care for this patient population, Habermann says. However, the additional results from this study are still anticipated, which will allow for further interpretation. 

In addition to the TRIANGLE study, across the fields of MCL and MZL, the results of various phase 2 and phase 3 trials are pending, Habermann says. For example, a phase 3 trial (NCT04002297) is examining zanubrutinib (Brukinsa) plus rituximab (Rituxan) vs bendamustine (Bendeka) plus rituximab in previously untreated patients with MCL. The study is ongoing and data have not yet been reported. Additionally, data from a phase 3 trial (NCT02972840) evaluating bendamustine and rituximab with or without acalabrutinib (Calquence) in patients with treatment-naïve MCL are also pending, Habermann says, indicating that this is a different approach than what has previously been studied.

Finally, a multicenter, randomized, double-blind, placebo-controlled phase 3 trial (NCT04212013) is investigating the use of ibrutinib in combination with rituximab vs ibrutinib plus placebo in patients with treatment-naïve MZL, Habermann concludes.