A phase Ib study of a PI3Kδ inhibitor Linperlisib in patients with relapsed or refractory peripheral T-cell lymphoma.

• DOI: 10.1200/jco.2021.39.15_suppl.7531
• Publication Date: 2021-06-02T14:31:50Z
• Authors: Jie Jin; Hong Cen; Keshu Zhou; Xiaohong Xu; Fei Li; Tao Wu; Haiyan Yang; Zheng Wang; Zhiming Li; Lugui Qiu; Hanying Bao; Zusheng Xu; Yang Shu
• Keywords: Clinical endpoint; Peripheral T-cell lymphoma; Refractory (planetary science); Tolerability

7531 Background: PI3Kδ inhibitors have been shown to important roles in blocking mitogenic and survival signaling within the tumor cell microenvironment activate antilymphoma immune responses. Linperlisib is an oral highly selective small molecule inhibitor of has demonstrated be well-tolerated with a favorable PK profile patients lymphomas at RP2D. This phase Ib study evaluating efficacy safety relapsed or refractory peripheral T-cell lymphoma (PTCL), aggressive malignancy few treatment options for patients. Methods: Eligible PTCL who must received least 1 prior systemic conventional therapy were administrated 80mg orally once daily (RP2D) 28 days cycle until disease progression, unacceptable toxicity, withdrawal from study. Tumor response was assessed by IWG 2007 criteria CT performed every 2 cycles. The primary endpoint overall rate (ORR), secondary toxicity NCI-CTCAE5.0. Results: As February 2, 2021, 36 enrolled this exploratory trial. Most stage III (38.2%) IV (50%). Of 27 evaluable date, histologies PTCL-NOS (n=12), AITL (n=10), ALCL (n=3), NKTCL (n=1) MEITL (n=1). 19 had Investigator confirmed responses 70.4% ORR including 25.9% CR (7pt) 44.4% PR (12pt). In major subtypes, 50% (6/12) 80% (8/10) AITL, respectively. A control 100% observed, most occurred first assessment C2D28. One subject C2D28 currently 9 continuing on Linperlisib. experienced AE trial, 95% AEs ≤ grade 2. Consistent previously treated patients, no unexpected toxicities observed. common TRAEs (≥10%) neutrophil count decreased (55.6%), leukocyte (33.3%), hypertriglyceridemia (22.2%), aspartate aminotransferase increased (16.7%), hypercholesterolemia alanine (11.1%), creatinine rash thrombocyte (11.1%) electrocardiogram T wave abnormal (11.1%). No 4 6 (16.7%) one SAE, which SAEs considered drug-related, (2.8%), gastritis pneumonia (5.6%). Conclusions: PI3Kd significant activity PTCL. Toxicities generally tolerable manageable. Further being evaluated. Clinical trial information: NCT04108325.