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

• Published in: Frontiers in oncology Vol. 12; p. 958043
• Main Authors: Evans, Rachel, Lee, Kelvin, Wallace, Paul K., Reid, Mary, Muhitch, Jason, Dozier, Askia, Mesa, Circe, Luaces, Patricia L., Santos-Morales, Orestes, Groman, Adrienne, Cedeno, Carlos, Cinquino, Aileen, Fisher, Daniel T., Puzanov, Igor, Opyrchal, Mateusz, Fountzilas, Christos, Dai, Tong, Ernstoff, Marc, Attwood, Kristopher, Hutson, Alan, Johnson, Candace, Mazorra, Zaima, Saavedra, Danay, Leon, Kalet, Lage, Agustin, Crombet, Tania, Dy, Grace K.
• Format: Journal Article
• Language: English
• Published: Frontiers Media S.A 03.08.2022
• Subjects: immune checkpoint inhibitor; immunotherapy; lung cancer; non-small cell lung cancer; Oncology; vaccine
• ISSN: 2234-943X; 2234-943X
• DOI: 10.3389/fonc.2022.958043

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.