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Supplementary Method 1 from Enhancer of Zeste Homolog 2 Inhibitor SHR2554 in Relapsed or Refractory Peripheral T-cell Lymphoma: Data from the First-in-Human Phase I Study

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posted on 2024-04-01, 07:21 authored by Yuqin Song, Zhengming Jin, Zhi-Ming Li, Yanyan Liu, Lanfang Li, Chuan He, Hang Su, Hui Zhou, Kunyan Li, Siguo Hao, Xuelan Zuo, Jianyuan Wu, Dengju Li, Meng Wu, Xiuhua Sun, Junyuan Qi, Zhen Cai, Zengjun Li, Yijing Li, Yanhua Huang, Jie Shen, Zhenyu Xiao, Jun Zhu

Supplementary Method. Inclusion and exclusion criteria of the dose-escalation, dose-expansion, and clinical expansion part I of this phase 1 study.

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ARTICLE ABSTRACT

Patients with peripheral T-cell lymphomas (PTCL) in the relapsed or refractory (r/r) setting have only a limited number of therapies available, and the prognosis is extremely poor. SHR2554 is an oral inhibitor against EZH2, a rational therapeutic target for lymphomas. This was a multicenter, two-part, phase I study of SHR2554 in r/r mature lymphoid neoplasms. In part I, 350 mg twice daily was established as the recommended phase II dose (RP2D) based on the findings during dose escalation and expansion; subsequently, selected lymphoma subtypes were recruited in clinical expansion cohorts to receive SHR2554 at RP2D. Here, we provide an in-depth assessment of SHR2554 at RP2D in subpopulation with r/r PTCL. Twenty-eight patients were included for analysis (17 angioimmunoblastic T-cell lymphoma and 11 not otherwise specified). Eighteen (64%) patients had received ≥2 lines of previous anticancer therapies. The objective response rate was 61% [95% confidence interval (CI), 41–78]. Responses were still ongoing in 59% (10/17) of the responders; estimated median duration of response was 12.3 months (95% CI, 7.4–not reached). Median progression-free survival was 11.1 months (95% CI, 5.3–22.0), and 12-month overall survival rate was 92% (95% CI, 72–98). The most common grade 3 or 4 treatment-related adverse events were decreased platelet count [nine (32%)] as well as decreased white blood cell count, decreased neutrophil count, and anemia [four (14%) for each]. No treatment-related deaths were reported. This extended follow-up analysis further supports SHR2554 as a therapeutic opportunity for patients with r/r PTCL.

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