Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study |
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| Affiliation: | 1. Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China;2. Department of Lymphoma, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou, China;3. Department of Oncology, Shanghai Dongfang Hospital, Tongji University, Shanghai, China;4. Department of Lymphoma, Guangdong Provincial People''s Hospital, Guangdong Academy of Sciences, Guangzhou, China;5. Department of Lymphoma and Myeloma, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union of Medical College, Tianjin, China;6. Department of Hematopathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China;7. Department of Hematopathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China;8. Department of Oncology, First Affiliated Hospital, Zhengzhou University, Zhengzhou, China;9. Department of Medical Oncology, Jiangsu Institute of Cancer Research, Jiangsu Red Cross Cancer Center, Jiangsu Cancer Hospital, Nanjing Medical University, Nanjing, China;10. Department of Hematology, Beijing Hospital, Beijing, China;11. JW Therapeutics (Shanghai) Co, Ltd, Shanghai, China;1. Department of Hematology, Singapore General Hospital, Singapore, Republic of Singapore;2. Department of Clinical and Translational Research, Singapore General Hospital, Singapore, Republic of Singapore;3. Patient Services, Blood Services Group, Health Sciences Authority, Singapore, Republic of Singapore;4. Cell Therapy Facility, Blood Services Group, Health Sciences Authority, Singapore, Republic of Singapore;5. Infection and Immunity Clinical Academic Group, St George''s, University of London, London, UK;1. Department of Surgery, Mayo Clinic, Rochester, Minnesota, USA;2. General Surgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt;3. Department for General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany;4. William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota, USA;5. Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota, USA;6. Gastroenterology Research Unit, Mayo Clinic and Foundation, Rochester, Minnesota, USA;7. Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota, USA;1. Department of Cell Biology, Zunyi Medical University, Zunyi, Guizhou Province, China;2. Department of Orthopedic Surgery, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China;1. Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, TN;2. Sarah Cannon Research Institute, Nashville, TN |
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| Abstract: | Background aimsThe RELIANCE study has demonstrated the activity and safety of relmacabtagene autoleucel (relma-cel) (JW Therapeutics [Shanghai] Co, Ltd, Shanghai, China), a CD19-targeted chimeric antigen receptor T-cell product, in patients with heavily pre-treated relapsed/refractory large B-cell lymphoma (r/r LBCL). This study aimed to report the updated 2-year data of the RELIANCE study.MethodsThe RELIANCE study (NCT04089215) was an open-label, multi-center, randomized, phase 1/2 registrational clinical trial conducted at 10 clinical sites in China. Adult patients with heavily pre-treated r/r LBCL were enrolled and received lymphodepletion chemotherapy followed by infusion of 100 × 106 or 150 × 106 relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as assessed by investigators. Secondary endpoints were duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety profiles.ResultsFrom November 2017 to January 2022, a total of 68 patients were enrolled, and 59 patients received relma-cel infusion. As of March 29, 2022, a total of 59 patients had a median follow-up of 17.9 months (range, 0.3–25.6). ORR was 77.59% (95% confidence interval [CI], 64.73–87.49) and complete response rate was 53.45% (95% CI, 39.87–66.66). Median DoR was 20.3 months (95% CI, 4.86–not reached [NR]) and median PFS was 7.0 months (95% CI, 4.76–24.15). Median OS was NR and 1-year and 2-year OS rates were 75.0% and 69.3%, respectively. Three (5.1%) patients experienced grade ≥3 cytokine release syndrome and two (3.4%) patients had grade ≥3 neurotoxicity.ConclusionsThe updated data of the RELIANCE study demonstrate durable response with and manageable safety profile of relma-cel in patients with heavily pre-treated r/r LBCL. |
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