Pembrolizumab-GVD in relapsed or refractory Hodgkin lymphoma: 5-year update of a multicenter phase 2 trial.
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Patel Kishan, Shah Gunjan L, Schöder Heiko, Ganesan Nivetha, Drill Esther, Hancock Helen, Davey Theresa, Santarosa Alayna Marie, Galasso Natasha, Kumar Anita, Lahoud Oscar B, Hamlin Paul A, Straus David J, Owens Colette N, Caron Philip C, Intlekofer Andrew M, Horwitz Steven M, Falchi Lorenzo, Palomba M Lia, Noy Ariela, Matasar Matthew J, Salles Gilles A, Vardhana Santosha A, Wills Beatriz, Yahalom Joachim, Dogan Ahmet, Zelenetz Andrew D, Wong Phillip, Toyomura Maho, Michaud Laure, Sen Filiz, Argyropoulos Kimon V, Moskowitz Craig H, Moskowitz Alison J
Аннотация
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.