ASH 2024 | Acalabrutinib, umbralisib & ublituximab (AU2) regimen in patients with de novo MCL

There is a substantial shift in treatment of patients with mantle cell lymphoma in frontline setting. Several recent presentations at ASH on TRIANGLE study, ENRICH, other cooperative group studies, begin to question the role of transplant. Furthermore, they begin to question the role of chemoimmunotherapy in treatment of mantle cell lymphoma in frontline setting. So in this study, we used a chemotherapy-free regimen, which combined acalabrutinib, ublituximab, and umbralisib in patients with mantle cell lymphoma. As U2 regimen has been discontinued from its development due to concerns of toxicities of PI3K inhibitors, we only enrolled 12 patients on this study. However, we have shown that despite the fact that half of the patients, six out of 12 patients, carried high-risk genetic features, specifically P53 aberrations and complex karyotype, 100% of patients achieved complete metabolic response. And while patients who harbored P53 mutations progressed earlier, most of them progressed in the first two years in trial, patients who did not have P53 mutations, many of them still remain on study to this day. They already completed AU2 regimen and some of them are off treatment but in remission and others continue treatment with acalabrutinib. The regimen was very well tolerated, patients did not require admission of course for this treatment and overall, the rate of infection is very low and so I believe that chemo-free regimens are the future in treatment of frontline mantle cell lymphoma.

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