Details

Autor(en) / Beteiligte

• Gopal, Ajay K.
• Chen, Robert
• Smith, Scott E.
• Ansell, Stephen M.
• Rosenblatt, Joseph D.
• Savage, Kerry J.
• Connors, Joseph M.
• Engert, Andreas
• Larsen, Emily K.
• Chi, Xuedong
• Sievers, Eric L.
• Younes, Anas

Titel

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

Ist Teil von

• Blood, 2015-02, Vol.125 (8), p.1236-1243

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2015

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 (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. •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.