Abstract
BackgroundPeripheral 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.MethodsWe 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.ResultsBetween 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.ConclusionsIn 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.
Highlights
According to the 2016 World Health Organization classification of lymphoid neoplasms [1], peripheral T cell lymphomas (PTCLs) were classified into 27 distinct subtypes
Patients were excluded if histologically classified as adult T cell leukemia/lymphoma (ATLL) or Angioimmunoblastic T cell lymphoma (AITL); concomitant receipt of immunosuppressive therapy; prior exposure to any anti-progressive disease (PD)-1/programmed death-ligand 1 (PD-L1) or anti-cytolytic T lymphocyte-associated antigen-4 (CTLA-4) antibody; treatment with systematic corticosteroids (> 10 mg daily prednisone equivalent) within 2 weeks; active or history of autoimmune disease except for type I diabetes, controllable hypothyroidism with replacement treatment, controllable skin disorders without systematic treatment, celiac disease within control; human immunodeficiency virus (HIV) infection, anti-treponema pallidum antibody (TP-Ab) positive or active hepatitis B or C; use of any investigational agent, biologics or devices within 30 days before study treatment
We summarized Adverse event (AE) as the proportion of the total number of patients receiving at least one dose of geptanolimab
Summary
According to the 2016 World Health Organization classification of lymphoid neoplasms [1], peripheral T cell lymphomas (PTCLs) were classified into 27 distinct subtypes. This heterogeneous disease entity accounts for around 25% of non-Hodgkin lymphoma (NHL) patients in China and about 10% in USA and Europe [2, 3]. Due to its heterogeneity and rarity, most of the clinical studies conducted in PTCL were retrospective with a small sample size in which the treatment regimens largely followed B cell NHL. 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
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