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ASH 2022 | AU2: a highly effective regimen in patients with previously untreated MCL

Alexey Danilov, MD, PhD, City of Hope, Duarte, CA, discusses initial results of a Phase II trial of acalabrutinib with PI3Kδ inhibitor umbralisib and the anti-CD20 antibody ublituximab (AU2) in patients with previously untreated mantle cell lymphoma (MCL). Overall, results have so far shown that the AU2 is a highly effective regimen in patients with previously untreated MCL, proving the efficacy of chemotherapy-free regimens in this setting. This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA.

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Transcript (edited for clarity)

Acalabrutinib in combination with ublituximab and umbralisib or AU2 regimen, we studied this in previously untreated mantle cell lymphoma. This is a completely chemotherapy-free regimen which combines a BTK inhibitor, a PI3K inhibitor umbralisib, and a CD20 antibody ublituximab. And in this day and age, it becomes a subject of debate whether chemotherapy as an induction, initial induction therapy is even needed in mantle cell lymphoma...

Acalabrutinib in combination with ublituximab and umbralisib or AU2 regimen, we studied this in previously untreated mantle cell lymphoma. This is a completely chemotherapy-free regimen which combines a BTK inhibitor, a PI3K inhibitor umbralisib, and a CD20 antibody ublituximab. And in this day and age, it becomes a subject of debate whether chemotherapy as an induction, initial induction therapy is even needed in mantle cell lymphoma. If you look at the upcoming presentation of the TRIANGLE study, ibrutinib single agent actually outperformed chemotherapy followed by autologous stem cell transplant in terms of progression-free survival. So in our study, which is a smaller phase 2 study, we took exactly that approach. We used chemo-free induction regimen and we, so final 12 patients, all of whom achieved complete metabolic response by Lugano criteria. And we didn’t see any prohibitive side effects. So all patients remained on study. Unfortunately, at this point, one patient progressed, but the majority of patients still remain on therapy. So this is a highly effective regimen which highlights the high efficacy of chemo-free combinations in frontline therapy of mantle cell lymphoma.

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Disclosures

Nurix: Consultancy, Research Funding; Takeda Oncology: Research Funding; Astra Zeneca: Consultancy, Research Funding; Bayer Oncology: Research Funding; Bristol-Meyers-Squibb: Consultancy, Research Funding; Cyclacel: Research Funding; MEI: Consultancy, Research Funding; Abbvie: Consultancy, Research Funding; Genentech: Consultancy; Morphosys: Consultancy; Incyte: Consultancy; Beigene: Consultancy; GSK: Consultancy; Pharmacyclics: Consultancy.