Journal of Hematology & Oncology (Jan 2021)

Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)

  • Yuankai Shi,
  • Jianqiu Wu,
  • Zhen Wang,
  • Liling Zhang,
  • Zhao Wang,
  • Mingzhi Zhang,
  • Hong Cen,
  • Zhigang Peng,
  • Yufu Li,
  • Lei Fan,
  • Ye Guo,
  • Liping Ma,
  • Jie Cui,
  • Yuhuan Gao,
  • Haiyan Yang,
  • Hongyu Zhang,
  • Lin Wang,
  • Weihua Zhang,
  • Huilai Zhang,
  • Liping Xie,
  • Ming Jiang,
  • Hui Zhou,
  • Yuerong Shuang,
  • Hang Su,
  • Xiaoyan Ke,
  • Chuan Jin,
  • Xin Du,
  • Xin Du,
  • Li Liu,
  • Yaming Xi,
  • Zheng Ge,
  • Ru Feng,
  • Yang Zhang,
  • Shengyu Zhou,
  • Fan Xie,
  • Qian Wang

DOI
https://doi.org/10.1186/s13045-021-01033-1
Journal volume & issue
Vol. 14, no. 1
pp. 1 – 13

Abstract

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Abstract Background Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients. Methods We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria. Results Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30–22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2–51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related. Conclusions In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population. Trial registration: This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.

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