Addition of Decitabine to Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma
In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with relapsed or refractory classical Hodgkin lymphoma.
The study included 86 patients who had received at least 2 lines of previous therapy. Among these, 61 patients with no prior anti–PD-1 treatment were randomly assigned 1:2 to camrelizumab at 200-mg monotherapy every 3 weeks (n = 19) or decitabine at 10 mg/d on days 1 to 5 plus camrelizumab at 200 mg on day 8 every 3 weeks (n = 42). The 25 patients with prior anti–PD-1 treatment received combination therapy.
The primary endpoint was complete response rate and safety.
Responses
Median follow-up was 14.9 months. Among the anti-PD-1–naive patients, the complete response rate was 32% (6 of 19 patients) with camrelizumab monotherapy vs 71% (30 of 42 patients) with combination therapy (P = .003).
At the time of analysis, responses had persisted for 6 months in 76% of responders in the monotherapy group and 100% of responders in the combination group. Among patients who had previously received anti–PD-1 therapy, 28% achieved complete response and 24% achieved partial response with combination treatment; 81% of responders were estimated to have a response at more than 1 year.
Adverse Events
The most common treatment-related adverse events of any grade were cherry hemangiomas—which occurred in 84% of the monotherapy group and 87% all patients receiving combination therapy—and leukocytopenia, which occurred in 32% and 76%, respectively. Grade 3 to 4 leukocytopenia occurred in 39% of the combination group.
The investigators concluded, “Complete [response] rate in patients with relapsed [or] refractory [classical Hodgkin lymphoma] who were clinically naive 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 [or] refractory [classical Hodgkin lymphoma].”
Weidong Han, MD, of the Chinese People’s Liberation Army General Hospital, Beijing, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by the National Key Research and Development Program of China and the National Natural Science Foundation of China. For full disclosures of the study authors, visit jco.ascopubs.org.
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