Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study
Introduction: We examined the long-term efficacy and safety of nivolumab, a human monoclonal antibody that inhibits interactions between the programmed cell death protein-1 receptor and its ligands (programmed death-ligand 1 and programmed death-ligand 2), in Japanese patients with malignant pleural...
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Elsevier
2021-03-01
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| Series: | JTO Clinical and Research Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666364320301867 |
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| author | Nobukazu Fujimoto, MD, PhD Morihito Okada, MD, PhD Takashi Kijima, MD, PhD Keisuke Aoe, MD, PhD Terufumi Kato, MD Kazuhiko Nakagawa, MD, PhD Yuichiro Takeda, MD, PhD Toyoaki Hida, MD, PhD Kuninobu Kanai, MD, PhD Jun Hirano, MPharm Yuichiro Ohe, MD, PhD |
| author_facet | Nobukazu Fujimoto, MD, PhD Morihito Okada, MD, PhD Takashi Kijima, MD, PhD Keisuke Aoe, MD, PhD Terufumi Kato, MD Kazuhiko Nakagawa, MD, PhD Yuichiro Takeda, MD, PhD Toyoaki Hida, MD, PhD Kuninobu Kanai, MD, PhD Jun Hirano, MPharm Yuichiro Ohe, MD, PhD |
| author_sort | Nobukazu Fujimoto, MD, PhD |
| collection | DOAJ |
| description | Introduction: We examined the long-term efficacy and safety of nivolumab, a human monoclonal antibody that inhibits interactions between the programmed cell death protein-1 receptor and its ligands (programmed death-ligand 1 and programmed death-ligand 2), in Japanese patients with malignant pleural mesothelioma (MPM). Methods: Japanese patients with previously treated MPM (one or two regimens) were enrolled in a single-arm, phase 2 study and received nivolumab intravenously 240 mg every 2 weeks until progressive disease or unacceptable toxicity. The primary end point was the centrally assessed objective response rate. Other end points included overall survival (OS), progression-free survival (PFS), treatment-related adverse events, and patient-reported outcomes (Lung Cancer Symptom Scale for mesothelioma and EuroQOL visual analog scale). Patient enrollment started on June 16, 2016. Here, we report 3-year follow-up data (cutoff date: November 12, 2019). Results: Thirty-four patients were enrolled. The centrally assessed objective response rate was previously reported (29.4%). The 2- and 3-year OS rates were 35.3% and 23.5%, respectively, and the corresponding PFS rates were 17.0% and 12.7%. Median OS and PFS were 17.3 and 5.9 months, respectively. Eight patients were alive at 3 years of follow-up. Nivolumab was well tolerated and no new safety signals were found. The patient-reported outcomes were maintained without marked deteriorations during the study. Conclusions: Our results reveal clinically relevant long-term efficacy and safety of nivolumab for the treatment of MPM. |
| first_indexed | 2024-12-18T00:16:16Z |
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| institution | Directory Open Access Journal |
| issn | 2666-3643 |
| language | English |
| last_indexed | 2024-12-18T00:16:16Z |
| publishDate | 2021-03-01 |
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| spelling | doaj.art-6daaa024a9364fefa2c9b2eb6842a85c2022-12-21T21:27:31ZengElsevierJTO Clinical and Research Reports2666-36432021-03-0123100135Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT StudyNobukazu Fujimoto, MD, PhD0Morihito Okada, MD, PhD1Takashi Kijima, MD, PhD2Keisuke Aoe, MD, PhD3Terufumi Kato, MD4Kazuhiko Nakagawa, MD, PhD5Yuichiro Takeda, MD, PhD6Toyoaki Hida, MD, PhD7Kuninobu Kanai, MD, PhD8Jun Hirano, MPharm9Yuichiro Ohe, MD, PhD10Department of Medical Oncology, Okayama Rosai Hospital, Okayama, JapanDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, JapanDivision of Respiratory Medicine, Hyogo College of Medicine, Nishinomiya, JapanDepartment of Medical Oncology and Clinical Research, Yamaguchi-Ube Medical Center, Ube, JapanDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, JapanDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, JapanDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, JapanDepartment of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, JapanDepartment of Pulmonary Medicine and Oncology, Wakayama Medical University, Wakayama, JapanOncology Clinical Development Planning I, Oncology Clinical Development Unit, Ono Pharmaceutical Co., Ltd., Osaka, JapanDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Corresponding author. Address for correspondence: Yuichiro Ohe, MD, Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.Introduction: We examined the long-term efficacy and safety of nivolumab, a human monoclonal antibody that inhibits interactions between the programmed cell death protein-1 receptor and its ligands (programmed death-ligand 1 and programmed death-ligand 2), in Japanese patients with malignant pleural mesothelioma (MPM). Methods: Japanese patients with previously treated MPM (one or two regimens) were enrolled in a single-arm, phase 2 study and received nivolumab intravenously 240 mg every 2 weeks until progressive disease or unacceptable toxicity. The primary end point was the centrally assessed objective response rate. Other end points included overall survival (OS), progression-free survival (PFS), treatment-related adverse events, and patient-reported outcomes (Lung Cancer Symptom Scale for mesothelioma and EuroQOL visual analog scale). Patient enrollment started on June 16, 2016. Here, we report 3-year follow-up data (cutoff date: November 12, 2019). Results: Thirty-four patients were enrolled. The centrally assessed objective response rate was previously reported (29.4%). The 2- and 3-year OS rates were 35.3% and 23.5%, respectively, and the corresponding PFS rates were 17.0% and 12.7%. Median OS and PFS were 17.3 and 5.9 months, respectively. Eight patients were alive at 3 years of follow-up. Nivolumab was well tolerated and no new safety signals were found. The patient-reported outcomes were maintained without marked deteriorations during the study. Conclusions: Our results reveal clinically relevant long-term efficacy and safety of nivolumab for the treatment of MPM.http://www.sciencedirect.com/science/article/pii/S2666364320301867Malignant pleural mesotheliomaNivolumabProgrammed death-1Japan |
| spellingShingle | Nobukazu Fujimoto, MD, PhD Morihito Okada, MD, PhD Takashi Kijima, MD, PhD Keisuke Aoe, MD, PhD Terufumi Kato, MD Kazuhiko Nakagawa, MD, PhD Yuichiro Takeda, MD, PhD Toyoaki Hida, MD, PhD Kuninobu Kanai, MD, PhD Jun Hirano, MPharm Yuichiro Ohe, MD, PhD Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study JTO Clinical and Research Reports Malignant pleural mesothelioma Nivolumab Programmed death-1 Japan |
| title | Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study |
| title_full | Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study |
| title_fullStr | Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study |
| title_full_unstemmed | Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study |
| title_short | Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study |
| title_sort | clinical efficacy and safety of nivolumab in japanese patients with malignant pleural mesothelioma 3 year results of the merit study |
| topic | Malignant pleural mesothelioma Nivolumab Programmed death-1 Japan |
| url | http://www.sciencedirect.com/science/article/pii/S2666364320301867 |
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