Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity.

• DOI: 10.1200/jco.2024.42.16_suppl.7017
• Publication Date: 2024-06-28T20:19:52Z
• Authors: Yuqin Song; Keshu Zhou; Shuling Hou; Yan Zhang; Fei Li; Wei Yang; Tienan Yi; Ningjing Lin; Xingchen Liu; Wei Meng; Zhenjiu Wang; Qiying Lu; Wenzhi Tian; Jun Zhu
• Keywords: Tolerability; Clinical endpoint

7017 Background: Timdarpacept (IMM01), a recombinant SIRPa-Fc fusion protein, can activate macrophages to enhance anti-tumor activity by blocking CD47-SIRPa interaction. IMM01 showed unique property of weak human erythrocyte conjugation in preclinical studies, and low incidence anemia early clinical trials with no need for priming dose. combination tislelizumab has the potential augment both innate adaptive immune responses. Methods: Eligible patients R/R classical Hodgkin lymphoma (cHL) who have failed prior anti-PD-1 treatment were enrolled this open-label, multicenter phase II study (NCT05833984). (2.0mg/kg) intravenously administered each week 3-week cycle, while (200mg) will be once every 3 weeks until disease progression or intolerable toxicity. Objective response rate (ORR) Lugano 2014 was primary endpoint secondary endpoints include tolerability, control (DCR), duration (DoR), free survival (PFS) time (TTR). Results: As 28 Dec 2023, 33 cHL enrolled. The median age 35 years (range 19-77) 23 (69.7%) male patients. lines therapy 4. In efficacy evaluable (n=32) follow up 5.65 month (95% CI, 2.83-6.90), ORR 65.6% (21/32), complete 18.8% (6/32) DCR 93.8% (30/32). DoR at months, 6 months 92.9% 60.8%, respectively. mDoR not reached. PFS 84.5% 68.7%, Median TTR 1.6 months. Further analysis indicated that regardless resistance treatment, other PD-1-containing regimens (non-tislelizumab), CD30-ADC treatment; intervals from last dose PD-1 first tislelizumab, benefit combined treatment. All experienced least one treatment-related adverse events (TRAEs). most common TRAEs WBC decreased (48.5%), PLT (42.4%), (36.4%), ANC (33.3%), lymphocyte (30.3%). grade ≥3 occurred 15 (45.5%) patients, being (30.3%), (12.1%), (12.1%). There reported hemolytic hemolysis any 4 (12.1%) had related SAE. No leading drug discontinuation death. Conclusions: IMM01-04 robust effectivity well-tolerated safety profile is ongoing. Clinical trial information: NCT05833984 .