Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan

Akira Kawasaki; Kiyohiko Hatake; Itaru Matsumura; Koji Izutsu; Tomohiro Hoshino; Ayumi Akamatsu; Akito Kakuuchi; Kensei Tobinai

doi:10.1007/s12185-024-03734-y

Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan

Int J Hematol. 2024 Mar 23. doi: 10.1007/s12185-024-03734-y. Online ahead of print.

Authors

Akira Kawasaki¹, Kiyohiko Hatake², Itaru Matsumura³, Koji Izutsu⁴, Tomohiro Hoshino⁵, Ayumi Akamatsu⁵, Akito Kakuuchi⁵, Kensei Tobinai⁴

Affiliations

¹ Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan. ak.kawasaki@ono-pharma.com.
² Department of Hematology, International University of Health and Welfare, Tokyo, Japan.
³ Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, Osaka, Japan.
⁴ Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
⁵ Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan.

PMID: 38521840
DOI: 10.1007/s12185-024-03734-y

Abstract

Nivolumab was approved for relapsed/refractory classic Hodgkin lymphoma (cHL) in Japan in 2016. After its approval, a prospective, non-interventional, observational post-marketing surveillance was initiated to evaluate the safety and effectiveness of nivolumab treatment for up to 12 months in patients with relapsed/refractory cHL. Of 304 registered patients, 288 were included in safety analyses and 282 in effectiveness analyses. There were 191 (66.3%) male patients, median age was 64.0 years, and 54 patients (18.8%) had performance status ≥ 2. Treatment-related adverse events (TRAEs) were reported in 183 (63.5%) patients, with grade 3-5 TRAEs in 86 (29.9%). The most common TRAEs were infusion reaction (14.6%), hepatic function abnormal (5.9%), interstitial lung disease (ILD) (5.6%), and hypothyroidism (5.2%). TRAEs of special interest in ≥ 5% of patients were infusion reaction (15.6%), hepatic failure/hepatic dysfunction/hepatitis/cholangitis sclerosing (13.2%), thyroid dysfunction (9.7%), and ILD (7.3%). In multivariable analyses, prior allogeneic hematopoietic stem cell transplantation was a risk factor for hepatic failure/hepatic dysfunction/hepatitis/cholangitis sclerosing, and prior thyroid gland disorders was a risk factor for thyroid dysfunction. The overall response rate was 61.7%. In conclusion, nivolumab showed a similar safety profile and comparable effectiveness to that reported in clinical trials for relapsed/refractory cHL (CheckMate 205, ONO-4538-15).

Keywords: Classic Hodgkin lymphoma; Japan; Post-marketing surveillance; Safety.