Interim analysis of effectiveness and safety of Nivolumab 40 mg in relapsed/refractory Hodgkin lymphoma

Summary

Introduction

Aim of the study was to determine effectiveness and safety of therapy with Nivolumab 40 mg in patients with relapsed/refractory Hodgkin lymphoma.

Materials and methods

Intermediate analysis included 14 patients with relapsed/refractory Hodgkin lymphoma who were treated with nivolumab 40 mg once per 14 days until disease progression/unacceptable toxicity. Response was assessed by PET/CT using LYRIC criteria every 3 month (6 cycles). The safety was estimated by registration adverse effects according to NCI CTCAE 4.03.

Results

Median follow‐up time was 10 months. Median number of treatment cycles with nivolumab was 17 (12-22). Median dose of drug was 0,56 mg/kg (0.4-0.91 mg/kg). 9 patients (64.3%) achieved an objective response, 5 (35.7%) a complete response (CR), and 4 patients (28.6%) a partial response. 4 patients (28.6%) had intermediate response as their best response. Two (14.3%) patients had progressive disease (at the moment of 12th and 18th cycles). Ten (71.4%) patients had adverse effects (AE). Grade ¾ AE were reported in 3 (21%) patients and included an anemia, arthritis and hepatitis. In general, the treatment was well tolerated and the toxicity profile was similar to the previously published data.

Conclusion

According to the intermediate analysis, the structure of the response to therapy in patients treated with nivolumab 40 mg was comparable to patients treated with nivolumab in standard dose (3 mg/kg). The distribution of frequency, time of occurence and structure of adverse events was also similar to the standard therapy group. In conclusion, our data indicates that nivolumab 40 mg can be an effective and safety treatment option for R/R HL patients, but it’s nessesary to continue the study to obtain the final results.

Keywords

Hodgkin lymphoma, nivolumab, immunotherapy, PD1 inhibitors, relapsed lymphoma, refractory lymphoma.