[HTML][HTML] Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma
Y Liu, C Wang, X Li, L Dong, Q Yang… - … for immunotherapy of …, 2021 - ncbi.nlm.nih.gov
Y Liu, C Wang, X Li, L Dong, Q Yang, M Chen, F Shi, M Brock, M Liu, Q Mei, J Liu, J Nie…
Journal for immunotherapy of cancer, 2021•ncbi.nlm.nih.govBackground Programmed death-1 (PD-1) blockade monotherapy induced durable remission
in a subset of patients with relapsed/refractory classical Hodgkin lymphoma (cHL). We asked
whether the anti-PD-1 agent, camrelizumab, combined with the DNA demethylating agent,
decitabine, improves progression-free survival (PFS) in patients with relapsed/refractory cHL
over camrelizumab alone. Methods This extended follow-up of an ongoing randomized
phase II trial analyzed PFS among patients enrolled from January 2017 through July 2018 …
in a subset of patients with relapsed/refractory classical Hodgkin lymphoma (cHL). We asked
whether the anti-PD-1 agent, camrelizumab, combined with the DNA demethylating agent,
decitabine, improves progression-free survival (PFS) in patients with relapsed/refractory cHL
over camrelizumab alone. Methods This extended follow-up of an ongoing randomized
phase II trial analyzed PFS among patients enrolled from January 2017 through July 2018 …
Abstract
Background
Programmed death-1 (PD-1) blockade monotherapy induced durable remission in a subset of patients with relapsed/refractory classical Hodgkin lymphoma (cHL). We asked whether the anti-PD-1 agent, camrelizumab, combined with the DNA demethylating agent, decitabine, improves progression-free survival (PFS) in patients with relapsed/refractory cHL over camrelizumab alone.
Methods
This extended follow-up of an ongoing randomized phase II trial analyzed PFS among patients enrolled from January 2017 through July 2018. Sixty-one patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade and had received≥ 2 previous therapies were randomized 1: 2 to receive either camrelizumab (200 mg) monotherapy or camrelizumab (200 mg, day 8) combined with decitabine (10 mg/day, days 1–5) every 3 weeks.
Results
With a median follow-up of 34.5 months, complete remission was 79%(95% CI 63% to 90%) in the decitabine-plus-camrelizumab group versus 32%(95% CI 13% to 57%) in the camrelizumab group (p= 0.001). Median duration of response was not reached in the decitabine-plus-camrelizumab group, with an estimated 63%(95% CI 46% to 75%) of patients maintaining a response at 24 months. Median PFS with decitabine-plus-camrelizumab therapy was 35.0 months (95% CI not reached) and 15.5 months (95% CI 8.4 to 22.7 months) with camrelizumab monotherapy (HR, 0.46; 95% CI 0.21 to 1.01; p= 0.02). Female gender, lower tumor burden, and fewer previous therapies were favorable prognostic factors for durable remission with camrelizumab monotherapy. The PFS benefits of decitabine-plus-camrelizumab versus camrelizumab were observed in most subgroups, especially in patients with relative larger tumor burdens and those treated with≥ 3 prior therapies. After decitabine-plus-camrelizumab treatment, the percentage increase of circulating peripheral central memory T-cells correlated with both improved clinical response and PFS, suggesting a putative biomarker of decitabine-plus-camrelizumab therapy for cHL.
Conclusions
Decitabine-plus-camrelizumab results in longer PFS compared with camrelizumab alone in patients with relapsed/refractory cHL.
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