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Poster session 14

766P - Levels of serum EGF concentration as biomarker of response of CIMAvax-EFG vaccine: Survival evaluation of advanced NSCLC patients treated in primary health care scenario

Date

10 Sep 2022

Session

Poster session 14

Topics

Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Ramon Alberto Otiz Carrodeguas

Citation

Annals of Oncology (2022) 33 (suppl_7): S331-S355. 10.1016/annonc/annonc1058

Authors

R.A. Otiz Carrodeguas1, G. Lorenzo Monteagudo2, P.P. Guerra3, L. Sanchez4, L. Cárdenas5, I. Álvarez6, E.E. Salomón7, M. Díaz8, Y. Menéndez9, L. Lobaina10, J.C. Columbié11, K. Camacho12, M. Corella13, N. Fardales14, J. Parra3, C. Viada4, D. Saavedra15, O. Santos2, T. Crombet Ramos16

Author affiliations

  • 1 Clinical Oncology, Hospital Provincial Oncologico Universitario Celestino Hernández Robau, 50100 - Santa Clara/CU
  • 2 Clinical Trials Department, CIM - Center of Molecular Immunology, 11600 - Havana/CU
  • 3 Clinical Trials Department, National Coordinating Center for Clinical Trials, 11300 - Havana/CU
  • 4 Statistics, CIM - Center of Molecular Immunology, 11600 - Havana/CU
  • 5 Clinical Oncology, Manuel Ascunse Hospital, 70100 - Camagüey/CU
  • 6 Clinical Oncologys, Maria Curie Hospital, 70 700 - Camagüey/CU
  • 7 Clinical Oncology Department, Joaquín Albarrán Hospital, 10600 - La Habana/CU
  • 8 Clinical Oncology Department, Benéfico Jurídico Hospital, 12000 - La Havana/CU
  • 9 Clinical Oncology Department, Enrique Cabrera Hospital, 10800 - Havana/CU
  • 10 Clinical Oncology Department, Saturnino Lora Hospital, 90100 - Santiago de Cuba/CU
  • 11 Clinical Oncology Department, Juan Bruno Zayas Hospital, 90400 - Santiago de Cuba/CU
  • 12 Clinical Oncology Department, Faustino Pérez Hospital, 40100 - Matanzas/CU
  • 13 Clinical Oncology Department, Vladimir Ilich Lenin Hospital, 80100 - Holguín/CU
  • 14 Clinical Oncology Department, Hospital Camilo Cienfuegos, 60100 - Sancti Spíritus/CU
  • 15 Laboratory Of Immunology, CIM - Center of Molecular Immunology, 11600 - Havana/CU
  • 16 Clinical Research Dept., CIM - Center of Molecular Immunology, 11600 - Havana/CU
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Abstract 766P

Background

Previous studies have shown that baseline concentrations of EGF in serum could be considered a biomarker of the efficacy of the therapeutic vaccine CIMAVax-EGF. The objective of this study is to evaluate the serum EGF concentration as biomarker of response of CIMAvax-EGF vaccine for the treatment of advanced NSCLC patients in primary health care scenario.

Methods

A phase IV clinical trial (Public Registry RPCEC00000205; Dec 14, 2015) was conducted in 121 policlinics and 24 hospitals in Cuba during 5 years. The database cutoff was performed in December 2021. A total of 741 advanced NSCLC patients were included without other treatment options due to progressive disease or comorbidities. CIMAvax-EGF was administered by intramuscular injection in four sites of administration (4 subdoses of 0.25 ml), every 2 weeks the first 4 doses and after this induction phase, monthly reinmunizations were given. Serum EGF concentrations was determined at baseline, before vaccine administration.

Results

The median overall survival time (mOS) for all vaccinated patients with EGF concentrations <870 pg/mL (n = 438) was 7.3 months and with EGF concentrations ≥870 pg/mL ( n = 211) was 6.2 months (p = 0.07). For patients who received at least 4 doses of CIMAvax-EGF (per protocol population, N=489), the mOS for EGF<870 pg/mL (n=334) was 10.2 months and with EGF ≥870 pg/mL (n = 155) was 8.9 months (p = 0.13). For patients who respond to the first line of oncospecific treatment, the mOS for EGF < 870 pg/mL (n = 216) was 12.6 months and for those with EGF ≥ 870 pg/mL was 11.8 months (p = 0.82). The subgroup of patients with ECOG 0 or 1, achieved survivals of 15.0 months for EGF<870pg/mL (n=65) and 14.9 for EGF ≥870 pg/mL (n=17), p=0.44.

Conclusions

The results showed that patients with high baseline serum EGF concentrations and poor prognosis, achieve comparable survival to those with low baseline serum EGF concentrationsa and better prognosis of the disease in terms of survival. Patients who received at least 4 doses of treatment, achieved response to first-line onco-specific treatment, and had ECOG between 1 and 2, received the greatest benefit.

Clinical trial identification

RPCEC00000205; Dec 14, 2015.

Editorial acknowledgement

Legal entity responsible for the study

Center of Molecular Immunology.

Funding

Center of Molecular Immunology.

Disclosure

G. Lorenzo Monteagudo: Non-Financial Interests, Institutional, Leadership Role: Center of Molecular Immunology. L. Sanchez: Non-Financial Interests, Institutional, Full or part-time Employment: Center of Molecular Immunology. C. Viada: Non-Financial Interests, Institutional, Full or part-time Employment: Center of Molecular Immunology. D. Saavedra: Non-Financial Interests, Institutional, Full or part-time Employment: Center of Molecular Immunology. O. Santos: Non-Financial Interests, Institutional, Full or part-time Employment: Center of Molecular Immunology. T. Crombet Ramos: Non-Financial Interests, Institutional, Project Lead: Center of Molecular Immunology. All other authors have declared no conflicts of interest.

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