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ICML 2025 | Long-term follow-up of the VALOR regimen in patients with untreated MCL
In this video, Tycel Phillips, MD, City of Hope, Duarte, CA, presents the long-term follow-up data of the VALOR regimen (lenalidomide, rituximab, and venetoclax) in patients with untreated mantle cell lymphoma (MCL), highlighting the impressive efficacy observed with this therapeutic approach in patients not harboring a TP53 mutation. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
We’re presenting long-term follow-up for a study that we opened in 2018. This study was built off of some of the data that came out of the Cornell group that looks at R-squared and at that point they had shown a seven-year long-term follow-up which demonstrated some durability of response of lenalidomide-rituximab in mantle cell lymphoma patients that were deemed not to be eligible for autologous stem cell transplantation...
We’re presenting long-term follow-up for a study that we opened in 2018. This study was built off of some of the data that came out of the Cornell group that looks at R-squared and at that point they had shown a seven-year long-term follow-up which demonstrated some durability of response of lenalidomide-rituximab in mantle cell lymphoma patients that were deemed not to be eligible for autologous stem cell transplantation. With the potency of the BCL2 inhibitor venetoclax, our goal was to sort of evaluate this combination, except in an all-comer patient population, and so we did not necessarily use the criteria of autologous stem cell transplant eligibility in the eligibility criteria.
So with our initial presentation, we did demonstrate some impressive efficacy and the minimal residual disease undetectability using the adaptive Clono-seq assay. And so at this recent congress, our job was just to present more long-term follow-up as we have usually about five years of follow-up, four plus years of follow-up for most of these patients. And so from the data set that we see, we did notice impressively enough in patients that did not have a p53 mutation, which was 23 of the 28 enrolled patients, we had no clinical relapses with the long-term follow-up. The patients who have obtained an MRD undetectable assay have remained in an undetectable state at the last check with the clinical assay, which for most patients was during the last year of rituximab maintenance. We did see the patients, unfortunately, with a p53 mutation, we had five patients, four of those five patients, unfortunately, have relapsed. And of those four that have relapsed, three, unfortunately, have succumbed to the disease.
So moving forward, we will continue to further evaluate this protocol. We’ve expanded the study to enroll an additional 50 patients. We’re excluding patients with p53 mutations in the expansion cohort. And we hope to sort of demonstrate that at least this regimen can contribute to the sort of ongoing sort of field of novel chemo-free regimens, especially maybe add a BTK-less sort of option in the frontline setting for this patient population.
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