Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma

Abstract

Key Points• A total of 47% of patients who achieved CR on brentuximab vedotin remain progression-free after being followed a median of 53 months.• Younger age, less functional impairment, and lower disease burden at baseline were associated with CR and prognostic for longer survival.We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N 5 102) after a median observation period of approximately 3 years. Median overall survival and progression-free survival were estimated at 40.5 months and 9.3 months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58% (95% CI: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control. The trial was registered at www.clinicaltrials.gov as #NCT00848926. (Blood. 2015;125(8):1236-1243

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“…BV may represent an optimal therapeutic candidate and displays a number of features favoring its use as a bridge to ASCT in HL patients achieving a suboptimal response to salvage treatment [19,32]. First, it has a toxicity profile that does not overlap with most agents used in conditioning regimens.…”

Targeted Drug Brentuximab Vedotin for Treatment of Relapsed or Refractory Cd30-Positive Hodgkin’s Lymphoma

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“…В качестве сравнения были взяты БВ, ХТ±ЛТ и ХТ±ЛТ с намерением проведения ал-лоТСК. Данные об эффективности БВ были взяты из ис-следования SG035-0003 [14,15].…”

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“…Longer-term follow-up from this study has shown that the responses have been very durable. Of the 34 patients who achieved a complete remission, 47% remain progression free with a median follow-up of 53.3 months [23].…”