Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study
Abstract HLX01 (HanliKang®) is a rituximab biosimilar that showed bioequivalence to reference rituximab in untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) in the phase 3 HLX01-NHL03 study. Here, we report the 5-year follow-up results from the open-label extension part. Patients were ra...
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| Language: | English |
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BMC
2024-01-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-024-11876-9 |
| _version_ | 1827329155086155776 |
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| author | Yan Qin Yongping Song Dong Wang Ou Bai Jifeng Feng Xiuhua Sun Lihua Qiu Jianmin Yang Yu Yang Zhao Wang Jianda Hu Huaqing Wang Hang Su Zhengming Jin Wenbin Qian Chuan Jin Mingzhi Zhang Ding Yu Li Liu Guoan Chen Yarong Li Tao Sun Jie Jin Huizheng Bao Xin Du Hui Zhou Gan Fu Yuankai Shi |
| author_facet | Yan Qin Yongping Song Dong Wang Ou Bai Jifeng Feng Xiuhua Sun Lihua Qiu Jianmin Yang Yu Yang Zhao Wang Jianda Hu Huaqing Wang Hang Su Zhengming Jin Wenbin Qian Chuan Jin Mingzhi Zhang Ding Yu Li Liu Guoan Chen Yarong Li Tao Sun Jie Jin Huizheng Bao Xin Du Hui Zhou Gan Fu Yuankai Shi |
| author_sort | Yan Qin |
| collection | DOAJ |
| description | Abstract HLX01 (HanliKang®) is a rituximab biosimilar that showed bioequivalence to reference rituximab in untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) in the phase 3 HLX01-NHL03 study. Here, we report the 5-year follow-up results from the open-label extension part. Patients were randomised to either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 plus CHOP (H-CHOP) every 21 days for up to six cycles. The primary efficacy endpoint was overall survival (OS), and secondary efficacy endpoint was progression-free survival (PFS). Of the 407 patients enrolled in HLX01-NHL03, 316 patients (H-CHOP = 157; R-CHOP = 159) were included in the 5-year follow-up for a median duration of 65.1 (range, 2.2–76.5) months. 96.5% of the patients had an International Prognostic Index (IPI) of 1 or 2, and 17.7% had bone marrow involvement. The 5-year OS rates were 81.0% (95% CI: 74.9–87.5%) and 75.4% (95% CI: 68.9–82.6%)( HR: 0.75, 95% CI 0.47–1.20; p = 0.23) while 5-year PFS rates were 77.7% (95% CI: 71.4–84.6%) and 73.0% (95% CI: 66.3–80.3%) (HR: 0.84, 95% CI 0.54–1.30; p = 0.43) in the H-CHOP and R-CHOP groups, respectively. Treatment outcomes did not differ between groups regardless of IPI score and were consistent with the primary analysis. H-CHOP and R-CHOP provided no significant difference in 5-year OS or PFS in previously untreated patients with low or low-intermediate risk DLBCL. |
| first_indexed | 2024-03-07T15:28:49Z |
| format | Article |
| id | doaj.art-7eecafad55844bb3b801aa99db2e8a55 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-07T15:28:49Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-7eecafad55844bb3b801aa99db2e8a552024-03-05T16:32:55ZengBMCBMC Cancer1471-24072024-01-0124111010.1186/s12885-024-11876-9Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 studyYan Qin0Yongping Song1Dong Wang2Ou Bai3Jifeng Feng4Xiuhua Sun5Lihua Qiu6Jianmin Yang7Yu Yang8Zhao Wang9Jianda Hu10Huaqing Wang11Hang Su12Zhengming Jin13Wenbin Qian14Chuan Jin15Mingzhi Zhang16Ding Yu17Li Liu18Guoan Chen19Yarong Li20Tao Sun21Jie Jin22Huizheng Bao23Xin Du24Hui Zhou25Gan Fu26Yuankai Shi27Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeDepartment of Hematology, the First Affiliated Hospital of Zhengzhou UniversityDepartment of Oncology, Army Characteristic Medical CenterDepartment of Hematology, Cancer Center, the First Hospital of Jilin UniversityDepartment of Oncology, Jiangsu Cancer Hospital, the Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Institute of Cancer ResearchDepartment of Medical Oncology, the Second Affiliated Hospital of Dalian Medical UniversityDepartment of Lymphoma, Tianjin Medical University Cancer HospitalDepartment of Hematology, Changhai Hospital, Naval Medical UniversityDepartment of Lymphoma & Head and Neck Tumors, Fujian Medical University Cancer HospitalDepartment of Hematology, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Hematology, Fujian Medical University Union HospitalDepartment of Medical Oncology, Tianjin Union Medical Centre of Nankai UniversityDepartment of Lymphoma, the Fifth Medical Center, Chinese PLA General HospitalDepartment of Hematology, the First Affiliated Hospital of Soochow UniversityDepartment of Hematology, the Second Affiliated Hospital, School of Medicine, Zhejiang UniversityDepartment of Oncology, Guangzhou Medical UniversityDepartment of Oncology, the First Affiliated Hospital of Zhengzhou UniversityDepartment of Oncology Medicine, Hubei Cancer HospitalDepartment of Hematology, the Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)Department of Hematology, the First Affiliated Hospital of Nanchang UniversityHematology and Oncology Department, the Second Hospital of Jilin UniversityDepartment of Breast Medicine, Liaoning Cancer HospitalDepartment of Hematology, the First Affiliated Hospital of Medical College of Zhejiang UniversityDepartment of Lymphology and Hematology, Jilin Provincial Cancer HospitalDepartment of Hematology, Guangdong Provincial People’s HospitalDepartment of Lymphoma & Hematology, Hunan Cancer HospitalDepartment of Hematology, Xiangya Hospital, Central South UniversityDepartment of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeAbstract HLX01 (HanliKang®) is a rituximab biosimilar that showed bioequivalence to reference rituximab in untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) in the phase 3 HLX01-NHL03 study. Here, we report the 5-year follow-up results from the open-label extension part. Patients were randomised to either rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 plus CHOP (H-CHOP) every 21 days for up to six cycles. The primary efficacy endpoint was overall survival (OS), and secondary efficacy endpoint was progression-free survival (PFS). Of the 407 patients enrolled in HLX01-NHL03, 316 patients (H-CHOP = 157; R-CHOP = 159) were included in the 5-year follow-up for a median duration of 65.1 (range, 2.2–76.5) months. 96.5% of the patients had an International Prognostic Index (IPI) of 1 or 2, and 17.7% had bone marrow involvement. The 5-year OS rates were 81.0% (95% CI: 74.9–87.5%) and 75.4% (95% CI: 68.9–82.6%)( HR: 0.75, 95% CI 0.47–1.20; p = 0.23) while 5-year PFS rates were 77.7% (95% CI: 71.4–84.6%) and 73.0% (95% CI: 66.3–80.3%) (HR: 0.84, 95% CI 0.54–1.30; p = 0.43) in the H-CHOP and R-CHOP groups, respectively. Treatment outcomes did not differ between groups regardless of IPI score and were consistent with the primary analysis. H-CHOP and R-CHOP provided no significant difference in 5-year OS or PFS in previously untreated patients with low or low-intermediate risk DLBCL.https://doi.org/10.1186/s12885-024-11876-9HLX01Rituximab biosimilarDLBCLOverall survivalHanliKang® |
| spellingShingle | Yan Qin Yongping Song Dong Wang Ou Bai Jifeng Feng Xiuhua Sun Lihua Qiu Jianmin Yang Yu Yang Zhao Wang Jianda Hu Huaqing Wang Hang Su Zhengming Jin Wenbin Qian Chuan Jin Mingzhi Zhang Ding Yu Li Liu Guoan Chen Yarong Li Tao Sun Jie Jin Huizheng Bao Xin Du Hui Zhou Gan Fu Yuankai Shi Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study BMC Cancer HLX01 Rituximab biosimilar DLBCL Overall survival HanliKang® |
| title | Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study |
| title_full | Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study |
| title_fullStr | Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study |
| title_full_unstemmed | Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study |
| title_short | Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study |
| title_sort | long term outcomes with hlx01 hanlikang r a rituximab biosimilar in previously untreated patients with diffuse large b cell lymphoma 5 year follow up results of the phase 3 hlx01 nhl03 study |
| topic | HLX01 Rituximab biosimilar DLBCL Overall survival HanliKang® |
| url | https://doi.org/10.1186/s12885-024-11876-9 |
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