Dr. Dreyling on Key Efficacy Results From the TRIANGLE Study in MCL

Martin Dreyling, MD, associate professor of medicine, University of Munich, head of the Lymphoma Program in the Department of Internal Medicine III, University Hospital of Munich (LMU), Germany, discusses key efficacy results from the phase 3 TRIANGLE study (NCT02858258) in mantle cell lymphoma (MCL).

The open-label trial evaluated the addition of ibrutinib (Imbruvica) to standard induction chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) and fixed 2-year maintenance for young patients with mantle cell lymphoma. Induction therapy consisted of R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone)/R-DHAP (rituximab, dexamethasone, cytarabine, cisplatin).

Patients were randomly assigned to 1 of 3 treatment arms including induction/maintenance ibrutinib plus induction chemoimmunotherapy with ASCT and, ibrutinib plus induction chemoimmunotherapy and maintenance ibrutinib without ASCT, or a standard arm of induction therapy and ASCT alone.

A head-to-head comparison of all treatment arms showed a 3-year failure-free survival (FFS) rate of 72% in the standard arm, 86% in the ibrutinib without ASCT arm, and 88% in the ibrutinib with ASCT arm, Dreyling states. Although overall survival (OS) data are not fully mature, the 3-year OS rates showed that patients receiving the ibrutinib induction/maintenance experience improved outcomes compared to patients receiving standard ASCT alone.

Moreover, investigators originally postulated that ASCT would retain its status as the current standard of care if it demonstrated superiority over ibrutinib, Dreyling continues. However, ibrutinib-containing arms demonstrated improved FFS, clinically meaningful benefit, and OS benefit regardless of whether ASCT was administered, he says. 

Although no verdict on the role of ASCT has been reached, the ibrutinib without ASCT regimen was also associated with decreased toxicity, implying that ASCT may no longer be considered a standard treatment component for this patient population.