Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study

Yuqin Song, Quanli Gao, Huilai Zhang, Lei Fan, Jianfeng Zhou, Dehui Zou, Wei Li, Haiyan Yang, Ting Liu, Quanshun Wang, Fangfang Lv, Haiyi Guo, Liudi Yang, Rebecca Elstrom, Jane Huang, William Novotny, Vivian Wei, Jun Zhu, Yuqin Song, Quanli Gao, Huilai Zhang, Lei Fan, Jianfeng Zhou, Dehui Zou, Wei Li, Haiyan Yang, Ting Liu, Quanshun Wang, Fangfang Lv, Haiyi Guo, Liudi Yang, Rebecca Elstrom, Jane Huang, William Novotny, Vivian Wei, Jun Zhu

Abstract

Prognosis is poor for patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) after failure of or who are ineligible for autologous stem cell transplant. We evaluated the efficacy and safety of tislelizumab, an investigational anti-PD-1 monoclonal antibody, in phase 2, single-arm study in Chinese patients with R/R cHL. The primary endpoint was overall response rate as assessed by an independent review committee, according to the Lugano 2014 Classification. Seventy patients were enrolled in the study and received at least one dose of tislelizumab. After median follow-up of 9.8 months, 61 (87.1%) patients achieved an objective response, with 44 (62.9%) achieving a complete response (CR). The estimated 9-month progression-free survival rate was 74.5%. Most common grade ≥3 adverse events (AEs) were upper respiratory tract infection and pneumonitis. Infusion-related reactions occurred in 27 (38.6%) patients, and 27 patients (38.6%) experienced an immune-related AE, the most common of which was thyroid dysfunction. Eleven (15.7%) patients experienced at least one treatment-emergent AE leading to dose interruption or delay. No deaths occurred due to AEs. Treatment of patients with R/R cHL with tislelizumab was generally well tolerated and resulted in high overall response and CR rates, potentially translating into more durable responses for these patients.

Conflict of interest statement

HG, LY, RE, JH, WN, and VW are employees of BeiGene. YS, QG, HZ, LF, JZ, DZ, WL, HY, TL, QW, and FL declare that they have no competing financial interests.

Figures

Fig. 1
Fig. 1
Maximum change from baseline in the SPD of target lesions for all patients. Percentage change in SPD is presented by best response achieved in each patient
Fig. 2
Fig. 2
Overall response rate according to subgroup. This forest plot of data for 70 efficacy-evaluable patients shows the overall response rate according to defined demographic and baseline disease characteristics. The 95% confidence intervals are two-sided Clopper–Pearson estimations. For the category of baseline bone marrow involvement, “No” represents no involvement or not evaluable
Fig. 3
Fig. 3
a Progression-free survival by the Independent Review Committee (IRC) per the Lugano classification. Kaplan–Meier plot for progression-free survival (PFS; shown as the percentage of patients alive without disease progression) for the 70 efficacy-evaluable patients. The median PFS was not reached after a median follow-up of 9.6 months. b Duration of response by IRC per the Lugano classification with objective response. Kaplan–Meier plot for DOR for all 61 patients who had a response. The median DOR was not reached after a median follow-up of 6.7 months after the initial response. c Progression-free survival by IRC per response category (complete response or partial response)

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