Augmenting antibody response to EGF-depleting immunotherapy: Findings from a phase I trial of CIMAvax-EGF in combination with nivolumab in advanced stage NSCLC

被引:4
|
作者
Evans, Rachel [1 ]
Lee, Kelvin [2 ]
Wallace, Paul K. [1 ]
Reid, Mary [1 ]
Muhitch, Jason [1 ]
Dozier, Askia [1 ]
Mesa, Circe [3 ]
Luaces, Patricia L. [3 ]
Santos-Morales, Orestes [3 ]
Groman, Adrienne [1 ]
Cedeno, Carlos [1 ]
Cinquino, Aileen [1 ]
Fisher, Daniel T. [1 ]
Puzanov, Igor [1 ]
Opyrchal, Mateusz [2 ]
Fountzilas, Christos [1 ]
Dai, Tong [1 ]
Ernstoff, Marc [4 ]
Attwood, Kristopher [1 ]
Hutson, Alan [1 ]
Johnson, Candace [1 ]
Mazorra, Zaima [3 ]
Saavedra, Danay [3 ]
Leon, Kalet [3 ]
Lage, Agustin [3 ]
Crombet, Tania [3 ]
Dy, Grace K. [1 ]
机构
[1] Roswell Pk Comprehens Canc Ctr, Buffalo, NY 14203 USA
[2] Indiana Univ, Dept Med, Melvin & Bren Simon Comprehens Canc Ctr, Indianapolis, IN USA
[3] Ctr Immunol Mol, Havana, La Habana, Cuba
[4] Natl Canc Inst NCI, Div Canc Treatment & Diag, Bethesda, MD USA
来源
FRONTIERS IN ONCOLOGY | 2022年 / 12卷
关键词
immunotherapy; lung cancer; non-small cell lung cancer; immune checkpoint inhibitor; vaccine; LONG-TERM SURVIVAL; LUNG-CANCER; CHECKMATE; 017; VACCINE; DOCETAXEL; OUTCOMES; THERAPY; BURDEN; PD-1;
D O I
10.3389/fonc.2022.958043
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
BackgroundCIMAvax-EGF is an epidermal growth factor (EGF)-depleting immunotherapy which has shown survival benefit as a switch maintenance treatment after platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC). The primary objective of this trial is to establish the safety and recommended phase II dose (RP2D) of CIMAvax-EGF in combination with nivolumab as second-line therapy for NSCLC. MethodsPatients with immune checkpoint inhibitor-naive metastatic NSCLC were enrolled using a "3+3" dose-escalation design. Toxicities were graded according to CTCAE V4.03. Thirteen patients (one unevaluable), the majority with PD-L1 0%, were enrolled into two dose levels of CIMAvax-EGF. FindingsThe combination was determined to be safe and tolerable. The recommended phase 2 dose of CIMAvax-EGF was 2.4 mg. Humoral response to CIMAvax-EGF was achieved earlier and in a greater number of patients with the combination compared to historical control. Four out of 12 evaluable patients had an objective response.
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页数:11
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