A Multicenter Phase2 Trial of Linperlisib in Relapsed or Refractory Peripheral T/NK Cell Lymphomas

作者：Yuqin Song, Zengjun Li, Huijing Wu, Jie Jin, Hui Zhou, Keshu Zhou, Liling Zhang, Zhigang Peng, Zhiye Zhang, Hong Cen, Youchao Jia, Yue-Rong Shuang, Zhiming Li, Haiyan Yang, Liqun Zou, Zhifeng Li, Zhihui Zhang, Junmin Li, Junning Cao, Lugui Qiu, Shaojie Wu, Tiejun Gong, Xiaohong Xu, Zhen Wang, Jun Zhu · 发表于：Blood · 年份：2023 · DOI：10.1182/blood-2023-180137 · 被引用次数：7 · 研究领域：Lymphoma Diagnosis and Treatment、CAR-T cell therapy research、Immune Cell Function and Interaction

Introduction Peripheral T/NK cell lymphomas (PTCLs) are a group of aggressive heterogeneous non-Hodgkin's lymphomas where in relapsed or refractory (r/r) disease, the approved standard therapies are limited with a median progression free survival (mPFS) of only 3-4 months. PI3Kdelta inhibitors have demonstrated clinical activities in T-cell and B-cell lymphomas, owing to the multiple cellular activities in the T, B, and myeloid cell tumor microenvironment. However, application of these agents has been hampered by poor tolerabilities, particularly with toxicities such as diarrhea/colitis, hepatotoxicity, pneumonitis, hyperglycemia, and rash. As a new PI3Kdelta-selective oral agent, linperlisib was shown to be efficacious and indicated a favorable safety profile in phase 1 and 2 clinical trials in r/r Follicular Lymphoma (FL) and PTCL. Linperlisib received marketing approval in China in 2022 for r/r FL patients (pts) with 2 prior systemic therapies. Here we report the efficacy and safety findings for linperlisib in a pivotal phase 2 trial in r/r PTCL. Methods Ninety-eight pts were enrolled in the open-label phase 2 registration trial (CTR20210333) from May 2021 to October 2022 at 25 sites in China. The trial had a representation of different PTCL subtypes: AITL (48 pts), PTCL-NOS (24 pts), NKT (8 pts), ALCL (2 pts), MEITL (2 pts), Other (4 pts), and 10pt did not qualify as PTCL confirmed by independent pathology review, yielding a Full Analysis Set (FAS) of 88 pts for efficacy ...