Posted: Monday, December 19, 2022
Martin Dreyling, MD, PhD, of the Ludwig Maximilian University Hospital of Munich, and colleagues aimed to evaluate the combination of ibrutinib plus standard chemotherapy with or without autologous stem cell transplantation (ASCT) in younger patients with mantle cell lymphoma. Presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Plenary Abstract 1), the findings of this trial suggest that because the addition of ibrutinib demonstrated efficacy, it is noninferior to the current standard regimen.
“Based on our findings, standard chemotherapy plus ibrutinib (with or without ASCT) is the new [first-line] standard of care for patients [with mantle cell lymphoma],” said Dr. Dreyling in an ASH press release. “I think clinicians will interpret these results as suggesting you may essentially substitute autologous transplant with ibrutinib to avoid its well-known long-term toxicities.”
This study enrolled 870 patients with previously untreated, advanced stage II–IV mantle cell lymphoma. Participants were randomly assigned to receive standard treatment such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; n = 288), ibrutinib plus R-CHOP (n = 292), or an ibrutinib-containing treatment without ASCT (n = 290).
The rate of overall survival for those on standard therapy alone was 94%, and the rate of complete response was 36%; the respective rates for all other patients were 98% and 45%. After the median follow-up of 31 months, standard therapy did not demonstrate superiority over ibrutinib, but standard therapy plus ibrutinib was superior to standard therapy alone (P = .0008).
The 3-year overall survival rate was 86% with standard treatment, 91% with standard treatment plus ibrutinib, and 92% with an ibrutinib-based regimen without ASCT. There were no observed differences in grade 3 to 5 adverse events between standard therapy and ibrutinib plus standard therapy. In contrast, there were more grade 3 to 5 adverse events during maintenance among those on combination therapy versus standard therapy or ibrutinib alone.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.