Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma
Mené sur 102 patients atteints d'un lymphome hodgkinien réfractaire/récidivant, cet essai évalue l'efficacité, du point de vue de la survie globale et de la survie sans progression, d'un conjugué anticorps-médicament, le brentuximab vedotin, administré après une greffe autologue de cellules souches (durée médiane de suivi : 3 ans)
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=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 on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% CI: 57%, 88%) and 58% (95% CI: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained complete remission, 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 complete remission 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 is registered to www.ClinicalTrials.gov as NCT00848926.