2021-12-13
First patient dosed in a pivotal study of Hengrui's novel EZH2 inhibitor (SHR2554) for the treatment of peripheral T-cell lymphoma
December 13, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the first patient had been dosed in a pivotal study to evaluate SHR2554 as monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).
About the Study
This pivotal study is the Part II of the Phase 1 study SHR2554-I-101 (NCT03603951). SHR2554-I-101 is a multicenter, single-arm, open-label, dose-escalation and dose expansion study, in which 231 patients are planned to be enrolled. Hengrui expects to seek conditional approval for SHR2554 in r/r PTCL based on the Part II data.
The primary endpoint for Part II is objective response rate (ORR) assessed by Independent Review Committee (IRC). The secondary endpoints include ORR assessed by investigators, progression-free survival (PFS), time to response (TTR), duration of response (DoR), overall survival (OS), incidence and severity of adverse events (AEs), etc.
About SHR2554
SHR2554 is a novel, potent, selective, small-molecule inhibitor of the histone methyltransferase enzyme, enhancer of zest homolog 2 (EZH2) developed by Hengrui. In pre-clinical studies, SHR2554 demonstrated best-in-class potential in both in vitro and in vivo models. Consistently, the clinical data showed favorable safety and compelling efficacy of SHR2554, with a clean AE profile in terms of grade ≥ 3 AEs such as lymphocyte reduction, fatigue, and glucose elevation as indirectly compared with in-class molecules.
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of clinically aggressive diseases associated with poor outcomes.1 Despite primary treatment protocols that are typically anthracycline-based and frequently involve consolidative autologous stem cell transplantation in the first remission, many patients experience disease progression.2 Data from the BC Cancer Agency reported the outcome of 153 PTCL patients with a median OS and PFS after relapse or progression of 5.5 and 3.1 months, respectively.3 There remains a high unmet medical need for improved treatment strategies in the relapsed or refractory setting.2
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 24th among the top 1,000 global pharma companies in 2021.4 Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
1. Foss, Francine M et al. “Peripheral T-cell lymphoma.” Blood vol. 117,25 (2011): 6756-67.
2. Foster, Cheryl, and John Kuruvilla. “Treatment approaches in relapsed or refractory peripheral T-cell lymphomas.” F1000Research vol. 9 F1000 Faculty Rev-1091. 4 Sep. 2020.
3. Mak, Vivien et al. “Survival of patients with peripheral T-cell lymphoma after first relapse or progression: spectrum of disease and rare long-term survivors.” Journal of clinical oncology: official journal of the American Society of Clinical Oncology vol. 31,16 (2013): 1970-6.
4. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.
BD Contact
Email: bd@hengrui.com
Phone: +86-21-61053532