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ASH 2024 | Final results of BRESELIBET: the addition of brentuximab vedotin to ESHAP in R/R Hodgkin lymphoma
Anna Sureda, MD, PhD, Catalan Institute of Oncology, Duran I Reynals Hospital, Barcelona, Spain, comments on the positive results of the Phase IIb BRESELIBET trial (NCT04378647), which investigated the addition of brentuximab vedotin (BV) to ESHAP chemotherapy in patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). Prof. Sureda highlights that the trial demonstrated a significant increase in complete metabolic remission (CMR) rates with the addition of BV to ESHAP, without a significant increase in toxicity, and that consolidation with BV after achieving CMR resulted in a 74% progression-free survival (PFS) rate. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
So we are going to present here at ASH 2024 the final results of the primary endpoint of this Phase IIb prospective clinical trial that basically randomizes 1:1 patients with primary refractory disease or patients with relapsed classical Hodgkin lymphoma to receive either three cycles of ESHAP or three cycles of brentuximab vedotin-ESHAP.
The primary objective is to increase the metabolic complete remission rate by the addition of brentuximab vedotin to ESHAP, which has been one of the classical and historical salvage chemotherapy protocols for patients with relapsed/refractory disease...
So we are going to present here at ASH 2024 the final results of the primary endpoint of this Phase IIb prospective clinical trial that basically randomizes 1:1 patients with primary refractory disease or patients with relapsed classical Hodgkin lymphoma to receive either three cycles of ESHAP or three cycles of brentuximab vedotin-ESHAP.
The primary objective is to increase the metabolic complete remission rate by the addition of brentuximab vedotin to ESHAP, which has been one of the classical and historical salvage chemotherapy protocols for patients with relapsed/refractory disease. The second part of the primary endpoint is to try to substitute autologous stem cell transplant, which is the standard of care for these patients, by consolidation of brentuximab vedotin if the patient achieved the metabolic complete remission.
So basically, in summary, we included 150 patients in the trial. The trial has been positive because the primary endpoint has been met and the addition of brentuximab vedotin to ESHAP is able to significantly increase the rate of metabolic complete remission after three cycles without a significant increment in the toxicity profile and without impairing the stem cell collection for a potential future autologous stem cell transplantation. We have been able to follow 80 patients that have been consolidated with brentuximab vedotin after reaching a metabolic complete remission either with ESHAP or brentuximab vedotin-ESHAP and not being transplanted. So the toxicity profile of BV in consolidation is quite similar to the one that we already know from the drug profile. So basically hematological toxicity and peripheral sensory neuropathy. And with a median follow-up of almost 18 months for those patients that entered this consolidation strategy, progression-free survival is around 74%. So we are quite happy with the results and of course the next plan is to have full publications and to follow those patients that have been consolidated with brentuximab vedotin with the objective to try to spare autologous stem cell transplant at least in a good risk group of patients.
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