Data 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

• DOI: 10.1158/1078-0432.c.6533216.v2
• Publication Date: 2023-04-14T11:23:12Z
• Authors: 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
• Keywords: Refractory (planetary science); Follicular lymphoma; Progression-free survival

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