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Efficacy and safety of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: an open-label, single-arm, phase 2 study

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Abstract

Ropeginterferon alfa-2b is a novel, site-selective, monopegylated recombinant human interferon alfa-2b. Safety and efficacy of ropeginterferon alfa-2b for the treatment of polycythemia vera were demonstrated in clinical studies conducted in European countries, but clinical studies in Japanese patients are lacking. This phase 2, open-label, multicenter, single-arm study investigated the safety and efficacy of ropeginterferon alfa-2b in 29 Japanese patients with polycythemia vera including young patients and patients with low thrombosis risk who are difficult to receive guideline-based standard treatments. The primary outcome of durable complete hematologic response without phlebotomy at months 9 and 12 was achieved by 8/29 (27.6%) patients. The fastest complete hematologic response was observed at week 12. A corresponding reduction in the JAK2 V617F allele burden from baseline to 52 weeks was also observed (mean ± standard deviation =  − 19.2% ± 22.6%). No new safety concerns were identified in Japanese patients when compared with previous studies of ropeginterferon alfa-2b in European populations; the most common treatment-related adverse events were alopecia (55.2%), fatigue (27.6%) and influenza-like illness (27.6%). Most treatment-related adverse events were mild or moderate, with none of grade ≥ 3. Ropeginterferon alfa-2b is a safe and efficacious treatment option in Japanese patients with polycythemia vera.

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Acknowledgements

The authors would like to thank Sally-Anne Mitchell, PhD, of Edanz, Japan, for medical writing services, which were funded by PharmaEssentia Japan K.K.

Funding

This research was supported by PharmaEssentia Corporation.

Author information

Authors and Affiliations

  1. Department of Hematology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan

    Yoko Edahiro & Norio Komatsu

  2. Laboratory for the Development of Therapeutics Against MPN, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan

    Yoko Edahiro & Norio Komatsu

  3. Department of Advanced Hematology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan

    Yoko Edahiro & Norio Komatsu

  4. Department of Transfusion Medicine and Cell Therapy, Mie University Hospital, 2-174 Edobashi, Tsu-shi, Mie, 514-8507, Japan

    Kohshi Ohishi

  5. Department of Hematology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

    Akihiko Gotoh

  6. Department of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, 454 Shitsukawa, Toon-shi, Ehime, 791-0295, Japan

    Katsuto Takenaka

  7. Department of Hematology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan

    Hirohiko Shibayama

  8. Division of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

    Takayuki Shimizu

  9. Department of Hematology, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan

    Kensuke Usuki

  10. Division of Hematology, Diabetes and Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki-city, Miyazaki, 889-1692, Japan

    Kazuya Shimoda

  11. Department of Pathology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-cho, Nakamura-ku, Nagoya-shi, Aichi, 453-8511, Japan

    Masafumi Ito

  12. Enhanced Pharmacodynamics, LLC, 701 Ellicott Street, Buffalo, NY, 14203, USA

    Scott A. VanWart

  13. PharmaEssentia USA Corporation, 35 Corporate Drive, Suite 325, Burlington, MA, 01803, USA

    Oleh Zagrijtschuk

  14. PharmaEssentia Corporation, 13F, No. 3, YuanQu Sreet, NanKang District, Taipei, 115, Taiwan

    Albert Qin

  15. PharmaEssentia Japan K.K, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107‑0051, Japan

    Hiroaki Kawase, Narihisa Miyachi, Toshiaki Sato & Norio Komatsu

  16. Department of Hematology and Oncology, University of Yamanashi, 1110 Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan

    Keita Kirito

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  1. Yoko Edahiro
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  2. Kohshi Ohishi
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Contributions

NK, KS, AQ, OZ, and NM designed the study and wrote the protocol. KK supervised the study. YE, KO, KK, AG, KT, HS, TaS, and KU contributed to clinical data collection. ToS and HK were responsible for the trial follow-up. NK, ToS, HK, AQ and NM analyzed and interpreted the data. SV conducted the pharmacokinetic analysis. NK and NM wrote and revised the manuscript in collaboration with the medical writer mentioned in the Acknowledgments. All authors contributed to and have approved the final version of the manuscript.

Corresponding author

Correspondence to Yoko Edahiro.

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Conflict of interest

YE reports grants or contracts from PharmaEssentia Japan K.K. and Meiji Seika Pharma Co., Ltd; and honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from PharmaEssentia Japan K.K., Novartis Pharma K.K. and Takeda Pharmaceutical Co., Ltd.; and participation on a data safety monitoring board or advisory board from PharmaEssentia Japan K.K. and Novartis Pharma K.K. KO has no conflicts of interest to declare. AG reports research funding from Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd., Chugai Pharmaceutical Co., Ltd., MSD K.K., Otsuka Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., and Nihon Pharmaceutical Co., Ltd; honoraria from Novartis Pharma K.K., Alexion Pharmaceuticals, Inc., Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd., Chugai Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Nihon Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., and Sanofi K.K.; consulting fees from PharmaEssentia Japan K.K., Chugai Pharmaceutical, and Alexion Pharmaceuticals, Inc.; and participation on a data safety monitoring board or advisory board from PharmaEssentia Japan K.K., Chugai Pharmaceutical, and Alexion Pharmaceuticals, Inc. KT reports research funding and consulting fees from Astellas Pharma Inc., PharmaEssentia Japan K.K., Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Otsuka Pharmaceutical Co., Ltd.; and honoraria from Novartis Pharma K.K., Kyowa Kirin Co., Ltd., MSD K.K. Ltd. and Alexion Pharmaceuticals, Inc. HS reports honoraria from Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Novartis Pharma K.K., Celgene K.K., Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca K.K., AbbVie G.K., SymBio Pharmaceuticals Ltd., Eisai Co., Ltd., and Kyowa Kirin Co., Ltd.; and research funding from PharmaEssentia Japan K.K., Janssen Pharmaceutical K.K., Ono Pharmaceutical Co., Ltd., Celgene K.K., Novartis Pharma K.K., Sanofi K.K., AstraZeneca K.K., AbbVie G.K., Eisai Co., Ltd., HUYA Bioscience International, LLC., and Chugai Pharmaceutical Co., Ltd.; and scholarship endowment from Astellas Pharma Inc., Teijin Pharma Ltd., Shionogi & Co., Ltd., Eisai Co., Ltd., Sanofi K.K., Taiho Pharmaceutical Co., Ltd., and Nippon Shinyaku Co., Ltd. TaS reports honoraria from Ono Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Eisai Co., Ltd., SymBio Pharmaceuticals Ltd., Takeda Pharmaceutical Co., Ltd., Celgene K.K., Bristol-Myers Squibb K.K., Kyowa Kirin Co., Ltd., and Pfizer Japan Inc. KU reports research funding from Astellas Pharma Inc., AbbVie GK, Apellis Pharmaceuticals, Inc., SymBio Pharmaceuticals Ltd., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Janssen Pharmaceutical K.K., Otsuka Pharmaceutical Co., Ltd., Amgen-Astellas Biopharma K.K., Takeda Pharmaceutical Co., Ltd., Nippon-Shinyaku Co., Ltd., Bristol Myers Squibb K.K., Amgen K.K., Alexion Pharmaceuticals, Inc., Incyte Biosciences Japan G.K., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Celgene K.K., Sumitomo Dainippon Pharma Co., Ltd., Chugai Pharmaceutical Co., Ltd., Pfizer Japan Inc., Mundipharma K.K., Yakult Honsha Co., Ltd., MSD K.K., Gilead Sciences, Inc., and Nippon Boehringer Ingelheim Co., Ltd.; and honoraria from Novartis Pharma K.K., Bristol Myers Squibb K.K., Sanofi K.K., Pfizer Japan Inc., AbbVie GK, Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Astellas Pharma Inc., Alexion Pharmaceuticals, Inc., Eisai Co., Ltd., MSD K.K., Otsuka Pharmaceutical Co., Ltd., Celgene K.K., Daiichi Sankyo Co., Ltd., Nippon-Shinyaku Co., Ltd., PharmaEssentia Japan K.K., Yakult Honsha Co., Ltd., SymBio Pharmaceuticals Ltd., and Chugai Pharmaceutical Co., Ltd. KS is a consultant for Sierra and reports research funding from PharmaEssentia Japan K.K., Chugai Pharmaceutical Co., Ltd., AbbVie GK, Kyowa Kirin Co., Ltd., Daiichi Sankyo Co., Ltd., Shionogi & Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Eisai Co., Ltd., Nippon Kayaku Co., Ltd., Takeda Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd., and Taisho Pharmaceutical Co., Ltd.; honoraria from Novartis Pharma K.K. and Takeda Pharmaceutical Co., Ltd.; and is a member of an advisory committee for AbbVie GK. MI reports honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Takeda Pharmaceutical Co., Ltd. and Novartis Pharma K.K. SV is an employee of Enhanced Pharmacodynamics, LLC. OZ is an employee of PharmaEssentia Corporation USA. AQ is an employee of PharmaEssentia Corporation, Taiwan. HK, NM and ToS are employees of PharmaEssentia Japan KK. NK is a consultant for AbbVie G.K., Otsuka Pharmaceutical Co., Ltd., Celgene K.K., Japan Tobacco Inc., and PharmaEssentia Japan K.K.; and reports honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Shire Japan K.K., Novartis Pharma K.K., and Takeda Pharmaceutical Co., Ltd.; and is the Chairperson and Executive Director of PharmaEssentia Japan K.K. KK reports honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis Pharma K.K., Takeda Pharmaceutical Co., Ltd., PharmaEssentia Japan K.K., Sanofi K.K., and AbbVie G.K.

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Edahiro, Y., Ohishi, K., Gotoh, A. et al. Efficacy and safety of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: an open-label, single-arm, phase 2 study. Int J Hematol 116, 215–227 (2022). https://doi.org/10.1007/s12185-022-03341-9

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  • DOI: https://doi.org/10.1007/s12185-022-03341-9

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