TY - JOUR
T1 - Pembrolizumab in relapsed or refractory Hodgkin lymphoma
T2 - 2-year follow-up of KEYNOTE-087
AU - Chen, Robert
AU - Zinzani, Pier Luigi
AU - Lee, Hun Ju
AU - Armand, Philippe
AU - Johnson, Nathalie A.
AU - Brice, Pauline
AU - Radford, John
AU - Ribrag, Vincent
AU - Molin, Daniel
AU - Vassilakopoulos, Theodoros P.
AU - Tomita, Akihiro
AU - von Tresckow, Bastian
AU - Shipp, Margaret A.
AU - Lin, Jianxin
AU - Kim, Eunhee
AU - Nahar, Akash
AU - Balakumaran, Arun
AU - Moskowitz, Craig H.
N1 - Funding Information:
Funding for this research was provided by Merck Sharp & Dohme Corp. Medical writing and/or editorial assistance, provided by Doyel Mitra and Matthew Grzywacz of the ApotheCom pembrolizumab team (Yardley, PA), was funded by Merck Sharp & Dohme Corp.
Publisher Copyright:
© 2019 by The American Society of Hematology
PY - 2019/10/3
Y1 - 2019/10/3
N2 - Programmed death-1 inhibitors are approved for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). We present the 2-year follow-up of the phase 2 KEYNOTE-087 study of pembrolizumab in 210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3). With a median follow-up of 27.6 months, the objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9), the complete response rate (CRR) was 27.6%, and the partial response (PR) rate was 44.3%. Median duration of response was 16.5 months (range, 0.01 to 27.01 [1, no progressive disease at last assessment]) in all patients, 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grades 3 and 4 occurred in 25 (12.0%) patients; none resulted in death. Results confirmed effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL. This trial was registered at www.clinicaltrials.gov as #NCT02453594.
AB - Programmed death-1 inhibitors are approved for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). We present the 2-year follow-up of the phase 2 KEYNOTE-087 study of pembrolizumab in 210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3). With a median follow-up of 27.6 months, the objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9), the complete response rate (CRR) was 27.6%, and the partial response (PR) rate was 44.3%. Median duration of response was 16.5 months (range, 0.01 to 27.01 [1, no progressive disease at last assessment]) in all patients, 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grades 3 and 4 occurred in 25 (12.0%) patients; none resulted in death. Results confirmed effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL. This trial was registered at www.clinicaltrials.gov as #NCT02453594.
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U2 - 10.1182/blood.2019000324
DO - 10.1182/blood.2019000324
M3 - Article
C2 - 31409671
AN - SCOPUS:85072945199
SN - 0006-4971
VL - 134
SP - 1144
EP - 1153
JO - Blood
JF - Blood
IS - 14
ER -