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

Autor:	Evans R; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Lee K; Department of Medicine Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, United States., Wallace PK; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Reid M; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Muhitch J; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Dozier A; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Mesa C; Centro de Immunologia Molecular, La Habana, Cuba., Luaces PL; Centro de Immunologia Molecular, La Habana, Cuba., Santos-Morales O; Centro de Immunologia Molecular, La Habana, Cuba., Groman A; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Cedeno C; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Cinquino A; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Fisher DT; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Puzanov I; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Opyrchal M; Department of Medicine Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, United States., Fountzilas C; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Dai T; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Ernstoff M; National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis, Bethesda, MD, United States., Attwood K; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Hutson A; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Johnson C; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States., Mazorra Z; Centro de Immunologia Molecular, La Habana, Cuba., Saavedra D; Centro de Immunologia Molecular, La Habana, Cuba., Leon K; Centro de Immunologia Molecular, La Habana, Cuba., Lage A; Centro de Immunologia Molecular, La Habana, Cuba., Crombet T; Centro de Immunologia Molecular, La Habana, Cuba., Dy GK; Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in oncology [Front Oncol] 2022 Aug 03; Vol. 12, pp. 958043. Date of Electronic Publication: 2022 Aug 03 (Print Publication: 2022).
DOI:	10.3389/fonc.2022.958043
Abstrakt:	Background: CIMAvax-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. Methods: Patients 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. Findings: The 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. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Evans, Lee, Wallace, Reid, Muhitch, Dozier, Mesa, Luaces, Santos-Morales, Groman, Cedeno, Cinquino, Fisher, Puzanov, Opyrchal, Fountzilas, Dai, Ernstoff, Attwood, Hutson, Johnson, Mazorra, Saavedra, Leon, Lage, Crombet and Dy.)
Databáze:	MEDLINE
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