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Observational Study
. 2024 Jun;119(6):667-676.
doi: 10.1007/s12185-024-03734-y. Epub 2024 Mar 23.

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

Akira Kawasaki  1 , Kiyohiko Hatake  2 , Itaru Matsumura  3 , Koji Izutsu  4 , Tomohiro Hoshino  5 , Ayumi Akamatsu  5 , Akito Kakuuchi  5 , Kensei Tobinai  4
Affiliations
Observational Study

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

Akira Kawasaki et al. Int J Hematol. 2024 Jun.

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.

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Conflict of interest statement

Akira Kawasaki, Tomohiro Hoshino, Ayumi Akamatsu, and Akito Kakuuchi are employees of the sponsor. Kiyohiko Hatake reported research funding from Ono Pharmaceutical in relation to this work; consulting fees from Meiji Seika Pharma; and honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Towa Pharmaceutical, Meiji Seika Pharma, Otsuka Pharmaceutical, Janssen Pharmaceutical, Aioi Nissay Dowa Insurance, Yakult Honsha, Daiichi Sankyo, and Chugai Pharmaceutical. Itaru Matsumura reported research funding from Ono Pharmaceutical in relation to this work; research grants from Ono Pharmaceutical, Janssen Pharmaceutical, Nippon Shinyaku, Kyowa Kirin, Sumitomo Dainippon Pharma, Shionogi & Co, Teijin Pharma, Boehringer Ingelheim, Sanofi, Chugai Pharmaceutical, Eisai, MSD, Asahi Kasei Pharma, Astellas Pharma, Takeda Pharmaceutical, Nihon Pharmaceutical, Daiichi Sankyo, AbbVie, Taiho Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Nippon Kayaku, CSL Behring, Mundipharma, AYUMI Pharmaceutical, Eli Lilly Japan, Actelion Pharmaceuticals Japan, and Amgen BioPharma; consulting fees from Otsuka Pharmaceutical; and speakers’ fees from Bristol-Myers Squibb (Celgene), Novartis, Otsuka, Pfizer Japan, Janssen, Astellas Pharma, Takeda Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, SymBio Pharmaceuticals, AbbVie, and Amgen BioPharma. Koji Izutsu reported research funding from Ono Pharmaceutical in relation to this work; grants from MSD, AstraZeneca, AbbVie, Eisai, Incyte, Bristol-Myers Squibb, Novartis, Pfizer, Janssen Pharmaceutical, Yakult, Kyowa Kirin, Ono Pharmaceutical, and Daiichi Sankyo; consulting fees from Bristol-Myers Squibb, AstraZeneca, Zenyaku, Kyowa Kirin, MSD, Nihon Shinyaku, AbbVie, Ono Pharmaceutical, Genmab, Mitsubishi Tanabe Pharma, and Nihon Kayaku; and honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bristol-Myers Squibb, AstraZeneca, Janssen, Eisai, Kyowa Kirin, Takeda Pharmaceutical, Chugai, Novartis, MSD, Symbio, Abbvie, Ono Pharmaceutical, Pfizer, Eli Lily, and Daiichi Sankyo. Kensei Tobinai reported research funding from Ono Pharmaceutical in relation to this work; consulting fees from Zenyaku Kogyo, Daiichi Sankyo, HUYA Bioscience International, and Mundipharma; honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Zenyaku Kogyo, Daiichi Sankyo, Celgene/Bristol-Myers Squibb, HUYA Bioscience International, Mundipharma, and Solasia Pharma.

Figures

Fig. 1
Fig. 1
Patient disposition. CRF case report form. Patients were registered between December 2, 2016, and December 31, 2019
See this image and copyright information in PMC

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References

    1. Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, et al. Distribution of malignant lymphoma in Japan: analysis of 2260 cases, 2001–2006. Pathol Int. 2008;58(3):174–182. doi: 10.1111/j.1440-1827.2007.02207.x. - DOI - PubMed
    1. Muto R, Miyoshi H, Sato K, Furuta T, Muta H, Kawamoto K, et al. Epidemiology and secular trends of malignant lymphoma in Japan: analysis of 9426 cases according to the world health organization classification. Cancer Med. 2018;7(11):5843–5858. doi: 10.1002/cam4.1805. - DOI - PMC - PubMed
    1. Küppers R. The biology of Hodgkin’s lymphoma. Nat Rev Cancer. 2009;9:15–27. doi: 10.1038/nrc2542. - DOI - PubMed
    1. Green MR, Monti S, Rodig SJ, Juszczynski P, Currie T, O’Donnell E, et al. Integrative analysis reveals selective 9p24.1 amplification, increased PD-1 ligand expression, and further induction via JAK2 in nodular sclerosing Hodgkin lymphoma and primary mediastinal large B-cell lymphoma. Blood. 2010;116(17):3268–77. doi: 10.1182/blood-2010-05-282780. - DOI - PMC - PubMed
    1. Sharpe AH, Wherry EJ, Ahmed R, Freeman GJ. The function of programmed cell death 1 and its ligands in regulating autoimmunity and infection. Nat Immunol. 2007;8(3):239–245. doi: 10.1038/ni1443. - DOI - PubMed

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