Frontiers in Oncology (Aug 2022)

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

  • Rachel Evans,
  • Kelvin Lee,
  • Paul K. Wallace,
  • Mary Reid,
  • Jason Muhitch,
  • Askia Dozier,
  • Circe Mesa,
  • Patricia L. Luaces,
  • Orestes Santos-Morales,
  • Adrienne Groman,
  • Carlos Cedeno,
  • Aileen Cinquino,
  • Daniel T. Fisher,
  • Igor Puzanov,
  • Mateusz Opyrchal,
  • Christos Fountzilas,
  • Tong Dai,
  • Marc Ernstoff,
  • Kristopher Attwood,
  • Alan Hutson,
  • Candace Johnson,
  • Zaima Mazorra,
  • Danay Saavedra,
  • Kalet Leon,
  • Agustin Lage,
  • Tania Crombet,
  • Grace K. Dy

DOI
https://doi.org/10.3389/fonc.2022.958043
Journal volume & issue
Vol. 12

Abstract

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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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