Ibrutinib added to ASCT improves clinical outcomes in mantle cell lymphoma 

In patients with previously untreated mantle cell lymphoma (MCL), autologous stem cell transplantation (ASCT) plus ibrutinib maintenance outperformed ASCT alone with regard to failure-free survival. Furthermore, ASCT alone did not prove to be superior to ibrutinib maintenance, but ibrutinib appeared to be favoured over ASCT in terms of toxicity.

The phase 3 Triangle study (NCT02858258) randomised 870 patients with previously untreated MCL younger than 66 years old 1:1:1 to 3 study arms:

• Arm A: R-CHOP/R-DHAP chemotherapy followed by ASCT and observation
• Arm A+I: R-CHOP/R-DHAP chemotherapy followed by ASCT and 2 years of ibrutinib maintenance therapy
• Arm I: R-CHOP/R-DHAP chemotherapy followed by ibrutinib maintenance therapy

Of note, rituximab maintenance was added to all 3 arms, following national guidelines. The primary endpoint was failure-free survival. Prof. Martin Dreyling (University Hospital Munich, Germany) presented the results [1].

The A+I arm was superior to the A arm in terms of failure-free survival, with 3-year rates of 88% and 72% (HR 0.52; P=0.0008). Next, the A arm did not outperform the I arm: the 3-year failure-free survival rate was 72% in the A arm and 86% in the I arm (HR 1.77; P=0.9979). Prof. Dreyling added that it was too soon to call whether the A+I arm was superior to the I arm. Similarly, the overall survival (OS) data were premature at time of the presentation, with 3-year OS rates of 86%, 91%, and 92% in the A arm, the A+I arm, and the I arm, respectively.

Haematologic adverse events (AEs) of grade 3 or higher appeared to be higher in the A+I arm (50%) than in the I arm (28%) or in the A arm (21%). Likewise, the rate of infection grade ≥3 was elevated in the A+I arm (25%) compared with the I arm (19%) and the A arm (13%).

1. Dreyling M, et al. Triangle: autologous transplantation after a rituximab/ibrutinib/ara-c containing induction in generalized mantle cell lymphoma – a randomized European MCL network trial. Abstract 1, ASH 64^th Annual Meeting, 10–13 December 2022, New Orleans, LA, USA.

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Posted on 20 February 202318 March 2024