TY - JOUR
T1 - Addition of low-dose decitabine to anti–PD-1 antibody camrelizumab in relapsed/refractory classical Hodgkin lymphoma
AU - Nie, Jing
AU - Wang, Chunmeng
AU - Liu, Yang
AU - Yang, Qingming
AU - Mei, Qian
AU - Dong, Liang
AU - Li, Xiang
AU - Liu, Jiejie
AU - Ku, Wenjing
AU - Zhang, Yan
AU - Chen, Meixia
AU - An, Xiaojing
AU - Shi, Lu
AU - Brock, Malcolm V.
AU - Bai, Jie
AU - Han, Weidong
N1 - Funding Information:
Funded by the National Key Research and Development Program of China (2016YFC1303501 and 2016YFC1303504; W.H.), the National Natural Science Foundation of China (31870873, 81872479, 81830002, 31671338, and 81472838), and Fostering Funds of Chinese PLA General Hospital for National Excellent Young Scholar Science Fund (2017-YQPY-001).
Funding Information:
Funded by the National Key Research and Development Program of China (2016YFC1303501 and 2016YFC1303504; W.H.), the National
Publisher Copyright:
Copyright © 2019 American Society of Clinical Oncology. All rights reserved
PY - 2019
Y1 - 2019
N2 - PURPOSE Anti–programmed death-1 (PD-1) monotherapy induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma (cHL), but complete remission (CR) is infrequently observed. As decitabine is known to boost T-cell function, we assessed the safety and efficacy of anti–PD-1 camrelizumab alone versus decitabine-primed camrelizumab in patients with relapsed/refractory cHL. METHODS This two-arm, open-label, phase II study enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy. Anti–PD-1 treatment-naïve patients were randomly assigned (1:2) to camrelizumab (200 mg) monotherapy or decitabine (10 mg/d, days 1 to 5) plus camrelizumab (200 mg, day 8) combination therapy every 3 weeks. Patients who were previously treated with anti–PD-1 were assigned combination therapy. Primary end point was CR rate and safety. RESULTS Overall, 86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months. In anti–PD-1–naïve patients, CR rate was 32% (six of 19 patients) with camrelizumab monotherapy versus 71% (30 of 42 patients) who were administered decitabine plus camrelizumab (P = .003). At the time of analysis, the response duration rate at 6 months was 76% on camrelizumab monotherapy versus 100% on decitabine plus camrelizumab. For patients who were previously treated with anti–PD-1, 28% achieved CR and 24% partial response after decitabine plus camrelizumab. Ten patients maintained a response at more than 6 months and 81% of responders were estimated to have a response at more than 1 year. For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting. CONCLUSION CR rate in patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade was significantly higher with decitabine plus camrelizumab than with camrelizumab alone. Decitabine plus camrelizumab may reverse resistance to PD-1 inhibitors in patients with relapsed/refractory cHL.
AB - PURPOSE Anti–programmed death-1 (PD-1) monotherapy induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma (cHL), but complete remission (CR) is infrequently observed. As decitabine is known to boost T-cell function, we assessed the safety and efficacy of anti–PD-1 camrelizumab alone versus decitabine-primed camrelizumab in patients with relapsed/refractory cHL. METHODS This two-arm, open-label, phase II study enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy. Anti–PD-1 treatment-naïve patients were randomly assigned (1:2) to camrelizumab (200 mg) monotherapy or decitabine (10 mg/d, days 1 to 5) plus camrelizumab (200 mg, day 8) combination therapy every 3 weeks. Patients who were previously treated with anti–PD-1 were assigned combination therapy. Primary end point was CR rate and safety. RESULTS Overall, 86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months. In anti–PD-1–naïve patients, CR rate was 32% (six of 19 patients) with camrelizumab monotherapy versus 71% (30 of 42 patients) who were administered decitabine plus camrelizumab (P = .003). At the time of analysis, the response duration rate at 6 months was 76% on camrelizumab monotherapy versus 100% on decitabine plus camrelizumab. For patients who were previously treated with anti–PD-1, 28% achieved CR and 24% partial response after decitabine plus camrelizumab. Ten patients maintained a response at more than 6 months and 81% of responders were estimated to have a response at more than 1 year. For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting. CONCLUSION CR rate in patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade was significantly higher with decitabine plus camrelizumab than with camrelizumab alone. Decitabine plus camrelizumab may reverse resistance to PD-1 inhibitors in patients with relapsed/refractory cHL.
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U2 - 10.1200/JCO.18.02151
DO - 10.1200/JCO.18.02151
M3 - Article
C2 - 31039052
AN - SCOPUS:85067371967
SN - 0732-183X
VL - 37
SP - 1479
EP - 1489
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 17
ER -