Pembrolizumab-GVD in relapsed or refractory Hodgkin lymphoma: 5-year update of a multicenter phase 2 trial.

Abstract

A phase II trial assessed the safety and efficacy of pembrolizumab, gemcitabine, vinorelbine, and liposomal doxorubicin (pembrolizumab-GVD) in transplant-eligible patients with relapsed/refractory (rel/rel) cHL, and demonstrated a complete response (CR) rate of 95% and progression-free survival (PFS) of 100% at 13.5 months (NCT03618550). We present an updated analysis of this trial at 5 years. Eligible patients received pembrolizumab 200mg intravenous (IV) (day 1), gemcitabine 1,000mg/m2 IV (days 1 and 8), vinorelbine 20mg/m2 IV (days 1 and 8), and liposomal doxorubicin 15mg/m2 IV (days 1 and 8) in 21-day cycles, followed by high-dose chemotherapy and autologous stem cell rescue (HDT/ASCR). Of 39 enrolled patients, 41% had primary refractory disease and 38% relapsed within 1 year of first-line treatment. In 38 response-evaluable patients, the CR and overall response rates after up to 4 cycles of pembrolizumab-GVD were 95% and 100%, respectively, with 35 patients (92%) attaining CR after only 2 cycles of therapy. Thirty-six (95%) patients underwent HDT/ASCR. After a median follow-up of 57 months, 1 patient experienced disease recurrence after per-protocol therapy, and 2 patients died from non-relapse or treatment-related causes. Estimated 5-year PFS and OS were 91% and 94%, respectively. No new safety signals were identified with extended follow-up.