Monday, December 3, 2018
BeiGene presents data on tislelizumab in Chinese patients with R/R cHL
BeiGene announced the presentation of clinical data from the pivotal Phase 2 trial of its investigational anti-PD-1 antibody, tislelizumab, in Chinese patients with relapsed/refractory, R/R, classical Hodgkin’s lymphoma, cHL. These data were presented in an oral session at the 60th Annual Meeting of the American Society of Hematology, taking place December 1-4, in San Diego, CA, and are included in BeiGene’s new drug application in China for tislelizumab for the treatment of patients with R/R cHL. “We set out to address the needs of patients with R/R cHL who have failed to achieve a response or progressed after autologous stem cell transplant. ASCT, or who are not candidates for ASCT, as these patients, unfortunately, have very poor outcomes,” said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “We are excited to report strong results including high complete response rates from the first registration study for this potentially differentiated anti-PD-1 agent.” Tislelizumab was discovered by BeiGene scientists, and is being developed globally and in China as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid and hematologic cancers with 11 Phase 3 or potentially registration-enabling studies ongoing or planned to initiate in the near term. The NDA for tislelizumab in China in patients with R/R cHL has been accepted by the China National Medical Products Administration and granted priority review status. “In this study, tislelizumab demonstrated an overall response rate, ORR, of 86%, including a CR rate of 61 %. Tislelizumab was also generally well-tolerated by patients with R/R cHL. We are excited by its clinical activity and believe that tislelizumab represents a potential new immunotherapy option for patients in China and elsewhere in the world,” said Yuqin Song, M.D., Ph.D., Associate Professor of Medical Oncology, Deputy Director of the Lymphoma Department at Peking University Cancer Hospital in China, and the presenting author of the study.
https://thefly.com/landingPageNews.php?id=2831485
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