AUTHOR=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. TITLE=Augmenting antibody response to EGF-depleting immunotherapy: Findings from a phase I trial of CIMAvax-EGF in combination with nivolumab in advanced stage NSCLC JOURNAL=Frontiers in Oncology VOLUME=12 YEAR=2022 URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.958043 DOI=10.3389/fonc.2022.958043 ISSN=2234-943X ABSTRACT=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.