PMID- 31520078 OWN - NLM STAT- MEDLINE DCOM- 20200804 LR - 20210209 IS - 1476-5551 (Electronic) IS - 0887-6924 (Print) IS - 0887-6924 (Linking) VI - 34 IP - 2 DP - 2020 Feb TI - Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. PG - 533-542 LID - 10.1038/s41375-019-0545-2 [doi] AB - Prognosis is poor for patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) after failure of or who are ineligible for autologous stem cell transplant. We evaluated the efficacy and safety of tislelizumab, an investigational anti-PD-1 monoclonal antibody, in phase 2, single-arm study in Chinese patients with R/R cHL. The primary endpoint was overall response rate as assessed by an independent review committee, according to the Lugano 2014 Classification. Seventy patients were enrolled in the study and received at least one dose of tislelizumab. After median follow-up of 9.8 months, 61 (87.1%) patients achieved an objective response, with 44 (62.9%) achieving a complete response (CR). The estimated 9-month progression-free survival rate was 74.5%. Most common grade >/=3 adverse events (AEs) were upper respiratory tract infection and pneumonitis. Infusion-related reactions occurred in 27 (38.6%) patients, and 27 patients (38.6%) experienced an immune-related AE, the most common of which was thyroid dysfunction. Eleven (15.7%) patients experienced at least one treatment-emergent AE leading to dose interruption or delay. No deaths occurred due to AEs. Treatment of patients with R/R cHL with tislelizumab was generally well tolerated and resulted in high overall response and CR rates, potentially translating into more durable responses for these patients. FAU - Song, Yuqin AU - Song Y AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China. FAU - Gao, Quanli AU - Gao Q AD - Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. FAU - Zhang, Huilai AU - Zhang H AD - Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China. FAU - Fan, Lei AU - Fan L AD - Department of Hematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China. FAU - Zhou, Jianfeng AU - Zhou J AD - Department of Hematology, Tongji Hospital, Tongji Medical College, Wuhan, China. FAU - Zou, Dehui AU - Zou D AD - State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. FAU - Li, Wei AU - Li W AD - Department of Hematology, Cancer Center, The First Hospital of Jilin University, Changchun, China. FAU - Yang, Haiyan AU - Yang H AD - Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, China. FAU - Liu, Ting AU - Liu T AD - Department of Hematology, West China Hospital of Sichuan University, Chengdu, China. FAU - Wang, Quanshun AU - Wang Q AD - Department of Hematology, Chinese PLA General Hospital, Beijing, China. FAU - Lv, Fangfang AU - Lv F AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Guo, Haiyi AU - Guo H AD - BeiGene (Beijing) Co., Ltd., Beijing, China. FAU - Yang, Liudi AU - Yang L AD - BeiGene (Beijing) Co., Ltd., Beijing, China. FAU - Elstrom, Rebecca AU - Elstrom R AD - BeiGene USA, Inc., San Mateo, CA, USA. FAU - Huang, Jane AU - Huang J AD - BeiGene USA, Inc., San Mateo, CA, USA. FAU - Novotny, William AU - Novotny W AD - BeiGene USA, Inc., San Mateo, CA, USA. FAU - Wei, Vivian AU - Wei V AD - BeiGene (Beijing) Co., Ltd., Beijing, China. FAU - Zhu, Jun AU - Zhu J AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China. zhu-jun2017@outlook.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20190913 PL - England TA - Leukemia JT - Leukemia JID - 8704895 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (PDCD1 protein, human) RN - 0 (Programmed Cell Death 1 Receptor) RN - 0KVO411B3N (tislelizumab) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antibodies, Monoclonal/*therapeutic use MH - Antibodies, Monoclonal, Humanized/*therapeutic use MH - Female MH - Hodgkin Disease/*drug therapy/metabolism MH - Humans MH - Lymphoma/*drug therapy/metabolism MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local/*drug therapy/metabolism MH - Prognosis MH - Programmed Cell Death 1 Receptor/*antagonists & inhibitors MH - Progression-Free Survival MH - Remission Induction/methods MH - Young Adult PMC - PMC7214259 COIS- HG, LY, RE, JH, WN, and VW are employees of BeiGene. YS, QG, HZ, LF, JZ, DZ, WL, HY, TL, QW, and FL declare that they have no competing financial interests. EDAT- 2019/09/15 06:00 MHDA- 2020/08/05 06:00 PMCR- 2019/09/13 CRDT- 2019/09/15 06:00 PHST- 2019/02/27 00:00 [received] PHST- 2019/05/01 00:00 [accepted] PHST- 2019/09/15 06:00 [pubmed] PHST- 2020/08/05 06:00 [medline] PHST- 2019/09/15 06:00 [entrez] PHST- 2019/09/13 00:00 [pmc-release] AID - 10.1038/s41375-019-0545-2 [pii] AID - 545 [pii] AID - 10.1038/s41375-019-0545-2 [doi] PST - ppublish SO - Leukemia. 2020 Feb;34(2):533-542. doi: 10.1038/s41375-019-0545-2. Epub 2019 Sep 13.