Nivolumab for relapsed or refractory Hodgkin lymphoma: Experience in Turkey

Background: PD-1 inhibitors have been approved by FDA for patients who relapse following autologous stem cell transplantation (SCT) and brentuximab vedotin (BV) therapy. This retrospective multicenter study aimed to provide information about the efficacy and safety of nivolumab in the “real-life” setting in Turkey. Methods: Twenty-three centers participated in this study. Eligible patients (pts) were required those treated with at least 1 cycle of nivolumab and with available response evaluation. Pts received nivolumab via a named-patient program, and it was administered at a dose of 3 mg/kg iv over 60 min q2wk. The study was approved by the local ethical commitee. Radiological response evaluation was performed in the early (at or before 12th week of treatment) and late (at or after 16th week of treatment) settings, according to the Lugano Classification and its update regarding immunomodulatory therapy. Results: Between 06/2015 and 11/2016, 87 pts were enrolled in the study. Two, 19, and 3 pts who had not yet received nivolumab, had not reach the time for early radiological evaluation, and who died before any radiological evaluation were excluded from the analysis. Thus, 63 pts were retrospectively analyzed (Table 1). The overall response rate (ORR) was 68% (95% CI, 0.020-0.28) among 59 pts evaluated in 12 weeks of treatment, and its ORR was 67% after 16 weeks of treatment (95% CI, 0.004-0.26). Estimated OS was 95% (95% CI, 0.80-0.98) and estimated PFS was 71% (95% CI, 0.55-0.82) at 12 months. Median OS was not reached, while, according to the late response rates, the median PFS was 14 months. However, it was only 3 months in pts with PD at the late radiological evaluation. Regarding responses to last treatment prior to nivolumab, we detected that 28 (67%) of 42 PD cases had objective early responses and 70% of 23 PD cases with late response evaluation had ORR (4 CR,12 PR). Eight pts had SCT following nivolumab. Among 5 pts who had been treated by allo-SCT, 4 had CR at the time of SCT, and they are alive with ongoing response. Safety profile was acceptable, and only 2 pts required cessation of nivolumab due to serious adverse events (autoimmune encephalitis and aggravation of graft versus host disease). At the time of analysis, 40 pts were still on nivolumab (64%). Among the 40 pts with early objective responses to nivolumab, 35 (88%) showed ongoing responses. All 24 pts with objective responses in the late evaluation had ongoing responses at the time of analysis. Keywords: Hodgkin lymphoma (HL); immunomodulators (IMIDs)