Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial

Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial.

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Item Type: Article
Official URL: https://doi.org/10.1158/1078-0432.CCR-20-0514
Journal or Publication Title: Clinical Cancer Research
Volume: 26
Number: 17
Page Range: pp. 4521-4530
Date: 2020
Divisions: Gene and Stem Cell Therapy
Depositing User: General Admin
Identification Number: 10.1158/1078-0432.CCR-20-0514
ISSN: 1078-0432
Date Deposited: 04 Jan 2021 01:20
Abstract:

Purpose: Patients with relapsed/refractory primary mediastinal B-cell lymphoma (rrPMBCL) represent a particularly challenging population to treat, with few life-saving treatment options in the context of a dismal prognosis.

Patients and Methods: In this open-label, single-arm, phase II study, the safety and efficacy of combined regimen of chemotherapy consisting of gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD) plus anti-PD-1 antibody camrelizumab was assessed in rrPMBCL. Patients received chemo-immunotherapy every 3 weeks until the second confirmed complete response (CR) or up to 12 cycles, followed by camrelizumab monotherapy for up to 1 year. The primary endpoints were objective response rate (ORR) and safety.

Results: Twenty-seven response evaluable patients were enrolled, who received a median of three first-line therapies, 59% with bulky disease. The ORR was 74%, including 56% with a CR. A median time of 1.7 months to response was observed, with 78% exhibiting tumor shrinkage at the first evaluation. After 24.8 months median follow-up, the median duration of response was not reached, with a 65% 2-year estimated response rate. Thirteen responders remained in sustained complete remission. Estimated 24-month progression-free survival and overall survival rates were 48.2% and 81.5%, respectively. Any grade and grade 3 treatment-related adverse events (AE) occurred in 93% and 33% of patients, respectively; with no grade 4 or 5 AEs. Baseline levels of IL10, IFNγ, and soluble Fas were associated with objective response.

Conclusions: Camrelizumab plus GVD chemotherapy offers a potent option as life-saving chemo-immunotherapy with promising efficacy and a manageable safety profile for patients with rrPMBCL, especially with bulky aggressive disease.

Creators:
Creators
Email
Mei, Qian
UNSPECIFIED
Zhang, Wenying
UNSPECIFIED
Liu, Yang
UNSPECIFIED
Yang, Qingming
UNSPECIFIED
Rasko, John E.J.
UNSPECIFIED
Nie, Jing
UNSPECIFIED
Liu, Jiejie
UNSPECIFIED
Li, Xiang
UNSPECIFIED
Dong, Liang
UNSPECIFIED
Chen, Meixia
UNSPECIFIED
Zhang, Yan
UNSPECIFIED
Shi, Lu
UNSPECIFIED
Wu, Huitao
UNSPECIFIED
Han, Weidong
UNSPECIFIED
Last Modified: 04 Jan 2021 01:20
URI: https://eprints.centenary.org.au/id/eprint/787

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