J&J Imbruvica gains EU approval for untreated Mantle Cell Lymphoma in transplant eligible patients

“MCL is still an aggressive, incurable disease and patients suffer under the burden associated with transplant,” said Martin Dreyling, M.D., Ph.D., Ludwig Maximilian University of Munich.** “As a targeted therapy, ibrutinib represents an opportunity to improve long term outcomes earlier in the treatment pathway. Patients now have a new standard of care in first line treatment that not only offers prolonged survival but also avoids short and long-term toxicities associated with high-dose chemotherapy and autologous stem cell transplant.”

“For more than a decade, ibrutinib has been the standard of care in relapsed or refractory MCL, transforming patient outcomes in later lines. Today’s approval for frontline use offers patients facing this aggressive blood cancer improved survival outcomes from the outset of treatment,” said Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “This milestone reinforces our commitment to evolving treatment paradigms in haematological malignancies through targeted, science-driven innovation.”

The approval for ibrutinib is supported by data from the open-label, randomised, Phase 3 TRIANGLE study conducted by the European MCL Network (NCT02858258). It evaluated 870 patients across three treatment arms to assess whether the addition of ibrutinib to chemoimmunotherapy (CIT) with or without ASCT could improve outcomes, when compared to ASCT + CIT alone, and potentially remove the need for transplant in patients with previously untreated MCL who were eligible for ASCT. At a median follow-up of 55 months, the findings demonstrated that treatment with ibrutinib plus CIT delivered significantly superior failure-free survival (FFS) while omitting the burden of ASCT (77 percent vs 68 percent at 54-months respectively; hazard ratio [HR], 0.639; 98 percent confidence interval [CI], 0.428–0.953; two-sided p=0.0068) and that ibrutinib + CIT provided significantly longer overall survival versus ASCT plus CIT (88 percent vs 78 percent at 54-months respectively; HR, 0.522; 95 percent CI, 0.341–0.799; two-sided p=0.0023).

The overall safety profile of the ibrutinib + CIT regimen was consistent with the previously known safety profile of ibrutinib.

“Until now, fit patients with mantle cell lymphoma have only had the option of frontline treatment with ASCT and chemotherapy. We’re incredibly proud that with this approval, ibrutinib has become the first alternative therapy for this patient population after demonstrating superior outcomes compared to the current standard of care,” said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “This approval reinforces our ongoing commitment to haematological malignancies, and the power of our collaborations with academics and researchers to bring cutting edge science to areas of high unmet need.”