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Safety and Efficacy of Anti-PD-1 Monoclonal Antibodies in Patients With Relapsed or Refractory Lymphoma: A Meta-Analysis of Prospective Clinic Trails.

ABSTRACT: Background: Immune checkpoint inhibition therapy with monoclonal antibody against programmed cell death protein 1 (PD-1), including nivolumab and pembrolizumab, has demonstrated powerful clinical efficacy in the treatment of advanced cancers. However, there is no evidence-based systematic review on the safety and efficacy of anti-PD-1 antibody in treating lymphoma. Methods: To evaluate the safety and efficacy of nivolumab/pembrolizumab, we analyzed clinical trials from PUBMED, EMBASE, and The Cochrane Library. For safety analysis, the incidence and exhibition of any grade and grade ?3 adverse events (AEs) were evaluated. Overall response rate (ORR), 6-month progression-free survival (PFS) and 6-month overall survival (OS) were calculated for efficacy analysis. Results: Overall ten studies and 718 patients (114 non-Hodgkin lymphomas, 604 Hodgkin lymphomas) were enrolled, including 4 phase I studies and 6 phase II studies. The pooled incidences of any grade and grade ?3 adverse events (AEs) were 74 and 24%, respectively. Drug-related deaths occurred in two patients. The most common any grade AEs were fatigue (14.91%), rash (14.8%), hypothyroidism (13.77%), platelet count decreased (13.54%), pyrexia (13%). The most common grade ?3 AEs were neutropenia (4.79%), pneumonitis (3.58%), rash (3.38%), and leukopenia (3.31%). Fatigue (p = 0.0072) and rash (p = 0.0078) in any grade AEs were less observed in patients treated with pembrolizumab than nivolumab. The pooled ORR, PFS rate and OS rate were 58, 73, and 96%, respectively. The ORR in patients with Hodgkin lymphomas (HL) was higher than patients with non-Hodgkin lymphomas (NHL) (69.08 vs. 30.77%, p < 0.0001). However, there was no significant difference of efficacy between nivolumab and pembrolizumab. Conclusions: Nivolumab and pembrolizumab have promising outcomes with tolerable AEs and drug-related deaths in patients with relapsed or refractory lymphoma. Pembrolizumab caused less any grade AEs like fatigue and rash than nivolumab. Patients with HL got better response than NHL.

SUBMITTER: Zhou H

PROVIDER: S-EPMC6504777 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Safety and Efficacy of Anti-PD-1 Monoclonal Antibodies in Patients With Relapsed or Refractory Lymphoma: A Meta-Analysis of Prospective Clinic Trails.

Zhou Hui H Fu Xiaoyan X Li Qian Q Niu Ting T

Frontiers in pharmacology 20190501

<b>Background:</b> Immune checkpoint inhibition therapy with monoclonal antibody against programmed cell death protein 1 (PD-1), including nivolumab and pembrolizumab, has demonstrated powerful clinical efficacy in the treatment of advanced cancers. However, there is no evidence-based systematic review on the safety and efficacy of anti-PD-1 antibody in treating lymphoma. <b>Methods:</b> To evaluate the safety and efficacy of nivolumab/pembrolizumab, we analyzed clinical trials from PUBMED, EMBA ...[more]

PMID: 31118893

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Project description:Preclinical studies suggest that Reed-Sternberg cells exploit the programmed death 1 (PD-1) pathway to evade immune detection. In classic Hodgkin's lymphoma, alterations in chromosome 9p24.1 increase the abundance of the PD-1 ligands, PD-L1 and PD-L2, and promote their induction through Janus kinase (JAK)-signal transducer and activator of transcription (STAT) signaling. We hypothesized that nivolumab, a PD-1-blocking antibody, could inhibit tumor immune evasion in patients with relapsed or refractory Hodgkin's lymphoma.In this ongoing study, 23 patients with relapsed or refractory Hodgkin's lymphoma that had already been heavily treated received nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks until they had a complete response, tumor progression, or excessive toxic effects. Study objectives were measurement of safety and efficacy and assessment of the PDL1 and PDL2 (also called CD274 and PDCD1LG2, respectively) loci and PD-L1 and PD-L2 protein expression.Of the 23 study patients, 78% were enrolled in the study after a relapse following autologous stem-cell transplantation and 78% after a relapse following the receipt of brentuximab vedotin. Drug-related adverse events of any grade and of grade 3 occurred in 78% and 22% of patients, respectively. An objective response was reported in 20 patients (87%), including 17% with a complete response and 70% with a partial response; the remaining 3 patients (13%) had stable disease. The rate of progression-free survival at 24 weeks was 86%; 11 patients were continuing to participate in the study. Reasons for discontinuation included stem-cell transplantation (in 6 patients), disease progression (in 4 patients), and drug toxicity (in 2 patients). Analyses of pretreatment tumor specimens from 10 patients revealed copy-number gains in PDL1 and PDL2 and increased expression of these ligands. Reed-Sternberg cells showed nuclear positivity of phosphorylated STAT3, indicative of active JAK-STAT signaling.Nivolumab had substantial therapeutic activity and an acceptable safety profile in patients with previously heavily treated relapsed or refractory Hodgkin's lymphoma. (Funded by Bristol-Myers Squibb and others; ClinicalTrials.gov number, NCT01592370.).

Dataset Information

Safety and Efficacy of Anti-PD-1 Monoclonal Antibodies in Patients With Relapsed or Refractory Lymphoma: A Meta-Analysis of Prospective Clinic Trails.

Publications

Safety and Efficacy of Anti-PD-1 Monoclonal Antibodies in Patients With Relapsed or Refractory Lymphoma: A Meta-Analysis of Prospective Clinic Trails.

Similar Datasets

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