Lung cancer vaccine – Experiences in Serbia

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Immunotherapy
Thoracic Malignancies
Presenter Zoran Andric
Citation Annals of Oncology (2018) 29 (suppl_9): ix150-ix169. 10.1093/annonc/mdy425
Authors Z.G. Andric
  • Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, 11080 - Belgrade/RS

Abstract

Background

Over the past decade, several types of vaccines have been used in the treatment of NSCLC. Cimavax® (anti-EGF ligand antibody) is one of the underlying research treatments. We present 32 patients with non-squamos NSCLC in stage IV in whom Cimavax egf® is administered in combination with chemotherapy (CHT).

Methods

This Phase II study was conducted in two Sites in Serbia from rythema 2015. To rythema 2016. In accordance with the national program for the use of Chimavax®. Inclusion criteria were: stage IV, ECOG PS ≤ 1, previously untreated, EGFR wild type, serum EGF concentrations 250pg/ml. Primary goal of this study was to evaluate prolonged progression free survival (PFS) >2 months between two arms: patients who received Cimavax® combined with chemotherapy and patients who received chemotherapy only (Gemcitabin, Platinum). We evaluated the serum EGF concentrations at the beginning of the treatment and control concentration. Patient received vaccine until PD.

Results

32 patients were enrolled in the first arm, average age 62.7 years, 16 males, 16 females. Most patients had only visceral metastases. The mean start serum EGF concentration was 870pg/ml. The maximum number of Cimavax® doses administered was eighteen. The best achived response is partial response (six patients), 21 patients had stable disease and five patients had PD, one still in maintenance phase. A better response was observed in patients with a higher initial serum EGF concentrations. Mean PFS value was 5.8 months (m). A prolonged PFS was observed in a group with a greater decline in serum EGF concentrations >50% (8m, maximum 15m). In the control arm, the mean PFS was in line with the literature data, 5,5m. Regarding the side effects most patients had nausea and vomiting most likely due to CHT rather then vaccine, other Aes were local reaction, fever, diarrhea, anemia, face rythema, myalgia. About 30% of patients had mark 7 on questionnaires (excellent quality of life). Overall survival was not delivered, 9 patients is alive, receiving secondary or tertiary CHT line.

Conclusions

We conclude that using Cimavax egf® vaccine provides satisfying control of the disease in the group of patients with significantly elevated EGF in the blood, provides good tolerance of therapy with a small number of side effects and good quality of life.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

National program of Ministry of Health of Republic of Serbia.

Funding

National program of Ministry of Health of Republic of Serbia.

Disclosure

The author has declared no conflicts of interest.