Sintilimab (anti-PD-1) plus ifosfamide, carboplatin, and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind phase 3 study (ORIENT-21).

作者：Peng Liu, Zhiming Li, Hong Cen, Zhengming Jin, Aimin Zang, Xiuhua Sun, Sujun Gao, Junning Cao, Qingyuan Zhang, Yufu Li, Xun Lai, Jishi Wang, Fei Li, Yang Shun-e, Wenbin Qian, Hongli Wang, Xiaoyi Tang, Luyin Ding, Hui Zhou, Yuankai Shi · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.7007 · 被引用次数：2 · 研究领域：Lymphoma Diagnosis and Treatment、Lung Cancer Treatments and Mutations、Multiple and Secondary Primary Cancers

7007 Background: Sintilimab monotherapy for cHL in third-line setting and beyond has been evaluated in a single-arm, phase 2 study ORIENT-1. Here, we present results of the phase 3 study ORIENT-21 evaluating sintilimab plus ICE versus placebo plus ICE as the second-line treatment for cHL. Methods: This study enrolled cHL pts who have failed first-line standard chemotherapy. The study has a safety run-in phase to enroll pts receiving sintilimab plus ICE, followed by a randomized phase in which pts were assigned in a 1:1 ratio to receive either sintilimab plus ICE (experimental arm) or placebo plus ICE (control arm) for 6 cycles. Patients without disease progression continued either sintilimab or placebo monotherapy. Stratification factors were age (<50 vs ≥50), disease status (relapsed vs refractory), and international prognostic score (IPS, <3 vs ≥3). Primary endpoint was complete remission rate (CRR) assessed by investigators according to Lugano 2014 criteria. Secondary endpoints included progression-free survival (PFS), duration of complete remission (DoCR) and safety. Results: As of Nov 21, 2024, 81 pts (ITT set: 10 in safety run-in, 34 in experimental arm, 37 in control arm) were enrolled (age≥50: 12.3%, IPS≥3: 18.5%, relapsed: 56.8%, refractory: 43.2%) with a median follow-up of 38.4 months (range: 0-58). In mITT set (randomized pts, n=71), significant higher CRR was observed in the experimental arm than the control arm (61.8% vs 32.4%, p=0.0295). Consistent result...