Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma: An updated review of published data from the named patient program.

Brentuximab vedotin was available via named patient program (NPP) to patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or systemic anaplastic large-cell lymphoma in ∼60 non-US/Canadian countries, before local approval. Published results were examined recently; through systematic literature review, we identified 12 new NPP publications. Most (10/12) publications included new NPP data describing 8 unique cohorts (N=480; all R/R HL) and new participating countries. Overall response rates were 58-80%, and complete remission rates were 10-40%. With median follow-up of 9.5-26 months, median progression-free survival was 5-10.5 months and median overall survival (OS) had not been reached in most cohorts; 1- and 2-year OS was 67-76% and 58-67%, respectively. Tolerability was as expected from previous reports. Despite intrinsic bias and heterogeneous cohorts, this update supports previous findings showing comparable efficacy and tolerability of brentuximab vedotin between real-world practice and phase 2 trial results in R/R HL.

Experience of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large-cell lymphoma in the Named Patient Program: Review of the literature.

Brentuximab vedotin was made available via a Named Patient Program (NPP) to non-US/Canadian patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL) until approval in their respective countries. We re-evaluated the efficacy and safety NPP data in a pooled analysis. Through a systematic literature review, 21 NPP publications were identified describing 14 cohorts (N=245). Among patients with a specified diagnosis, 207 had HL, 28 had ALCL, and one had CD30+ T-cell lymphoma (not specified). In cohorts reporting response, overall response and complete remission rates were 67% and 26%, respectively, in R/R HL, and 75% and 74%, respectively, in R/R ALCL. Incidences of grade 3/4 neurologic and hematologic toxicities were 6% and 12%, respectively; 5% of patients discontinued because of toxicity. In real-world practice, response rates and tolerability to brentuximab vedotin are similar to those reported in the two pivotal phase 2 trials in these settings.