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Mantle cell lymphoma (MCL) is an uncommon form of non-Hodgkin lymphoma, occurring 5–10% of patients with non-Hodgkin lymphoma globally. The treatment landscape for MCL is rapidly evolving. Currently, high-dose cytarabine-containing immunochemotherapy followed by autologous stem cell transplantation (ASCT) and rituximab maintenance therapy represents the standard of care (SOC) for younger patients with MCL. In recent years, Bruton's tyrosine kinase (BTK) inhibitors have shown promise as a more effective treatment protocol than SOC treatments, with ibrutinib demonstrating promising efficacy in relapsed and previously untreated older patients with MCL.
In younger patients with advanced MCL, it is unclear whether incorporation of ibrutinib into frontline therapy could improve outcomes. To address this, the European MCL Network is conducting the phase III, randomized, open-label TRIANGLE trial (NCT02858258) evaluating the addition of ibrutinib to standard treatment in comparison to the previous standard treatment and an ibrutinib regimen without ASCT.
Here, we report a summary of results from the ongoing phase III TRIANGLE trial of ibrutinib in younger patients with MCL presented by Dreyling at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2022, as part of the plenary scientific session.
The trial design is shown in Figure 1.
Figure 1. Trial design*†
ASCT, autologous stem cell transplantation; l, ibrutinib; R, rituximab; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; R-DHAP, rituximab, dexamethasone, cytarabine, cisplatin.
*Adapted from Dreyling, et al.1
†Rituximab maintenance was added in all three arms and was started (+/− ibrutinib) in 58%/57%/54% of A/A+I/I randomized patients, respectively.
TRIANGLE is an ongoing phase III, randomized, open-label, three-arm trial of ibrutinib to compare the effectiveness and safety of adding ibrutinib to standard treatment (arm A + I) vs previous standard treatment (arm A) and an ibrutinib containing treatment without ASCT (arm I) (Figure 1).
Between July 2016 and December 2020, 870 patients were selected for enrolment and randomized 1:1:1 to the three trial arms. Eligible patients were aged ≤65 years, had advanced previously untreated Stage II–IV MCL, an Eastern Cooperative Oncology Group Performance Score of 0–2, and were suitable for high-dose cytarabine and ASCT therapy.
The primary outcome was failure-free survival (FFS), with stable disease at the end of induction, progression, and death constituting qualifying events. Key secondary outcomes included response rates, progression-free survival, overall survival, and safety.
Figure 2. Efficacy outcomes*
CR, complete response; FFS, failure-free survival; OR, overall response; OS, overall survival.
*Adapted from Dreyling, et al.1
These results show that addition of ibrutinib to ASCT leads to improved FFS outcomes. In addition, neither ASCT-containing arm (arm A and arm A + l) had significantly better outcomes compared with the ibrutinib alone arm (arm l); however, therapy with ibrutinib alone had a more favorable safety profile. Longer-term follow-up results will indicate if these results remain consistent in younger patients with MCL.
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