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Supplementary Table S5 from The Oral PI3Kδ Inhibitor Linperlisib for the Treatment of Relapsed and/or Refractory Follicular Lymphoma: A Phase II, Single-Arm, Open-Label Clinical Trial

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posted on 2023-04-01, 00:26 authored by Tingyu Wang, Xiuhua Sun, Lihua Qiu, Hang Su, Junning Cao, Zhiming Li, Yuqin Song, Li Zhang, Dengju Li, Huijing Wu, Wei Zhang, Junmin Li, Keshu Zhou, Hui Zhou, Yu Yang, Zhifeng Li, Hong Cen, Zhen Cai, Zhihui Zhang, Weijun Fu, Jie Jin, Fei Li, Weixin Wu, Xuekui Gu, Weiliang Zhu, Lihong Liu, Zengjun Li, Shuhua Yi, Hanying Bao, Zusheng Xu, Lugui Qiu

Number and frequency of TRAE that led to discontinuation from the trial

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ARTICLE ABSTRACT

To investigate the efficacy and safety of the novel orally active PI3Kδ inhibitor in relapsed and/or refractory patients with follicular lymphoma (FL) who had received at least two prior systemic treatments. Histologically confirmed relapsed and/or refractory patients with FL with disease progression after receiving second-line or greater systemic therapy were enrolled. Linperlisib was administered at 80 mg every day, orally in a 28-day cycle until disease progression or intolerable toxicity occurred. The primary outcome for the study was the objective response rate (ORR), with secondary outcomes including the duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate, and drug safety profile. Of 114 screened relapsed and/or refractory patients with FL, 84 were enrolled in the full analysis set (FAS). The ORR of the 84 FAS patients was 79.8% [95% confidence interval (CI), 69.6–87.8, 67 patients], with 13 patients (15.5%) achieving a complete response and 54 patients (64.3%) with a partial response. The median DOR was 12.3 months (95% CI, 9.3–15.9). The median PFS was 13.4 months (95% CI, 11.1–16.7). The 12-month OS rate was 91.4% (95% CI, 82.7–95.8) and a median OS not reached by 42 months. The most frequent (>3%) treatment-related adverse events Grade ≥3 were infectious pneumonia (19.0%), neutropenia (15.5%), decreased lymphocyte count (4.8%), decreased leukocyte count (4.8%), increased lipase (3.6%), decreased platelet count (3.6%), hypertriglyceridemia (3.6%), and interstitial lung disease (3.6%). Linperlisib demonstrated compelling clinical activity and manageable tolerability for relapsed and/or refractory patients with FL who had received at least two prior systemic therapies.

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