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Maurenis Hernandez



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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-33 - Survival Benefit of Depleting High Serum EGF Concentration in Advanced NSCLC Patients as Switch Maintenance Therapy (Now Available) (ID 1931)

      10:15 - 18:15  |  Author(s): Maurenis Hernandez

      • Abstract
      • Slides

      Background

      Background: Serum EGF depleting immunotherapy (EDIT) with CIMAvax-EGF has shown to be safe and effective in the treatment of advanced NSCLC patients after first line of treatment with platinum based chemotherapy. The rationale of its use is to create an immune response against circulating serum EGF and by doing this prevent its binding to EGFR. Previous studies have shown that serum EGF levels above 870 pg/mL and response to chemotherapy (at least stable disease) are independent predictors of the response to EDIT. In this study we aimed to better estimate the benefit of this therapy in the population of first line responders with high basal serum EGF concentration

      Method

      To know the benefit of EDIT in overall survival compared to Best Support Care in this selected population, we pooled data data from three late stage clinical trials of CIMAvax-EGF in patients with advanced NSCLC (IC RD-EC056, IC RD-EC081, and IC RD-EC0120) after First Line Platinum based chemotherapy. The main outcome was overall survival.

      Result

      Out of 523 patients included in the study, 484 were responders (at least stable disease) to FLC. sEGF concentration above 870 pg/mL was measured in 106 patients, (74 and 32 in the EDIT and Control group, respectively). All 106 patients carrying these two protective distinctive features were included in the analyses. A significant benefit in median overall survival was found (14.6 m vs 9.6 m, p=0.001; 5 y survival rate: 22% vs 3%) favouring EDIT therapy.

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      Conclusion

      EGF Depleting Immunotherapy (EDIT) induces a survival benefit as Switch Maintenance in avanced NSCLC patients with high serum EGF concentration.

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      P2.01-92 - Cimavax-EGF in Combination with First-Line Chemotherapy in III Stage NSCLC (Now Available) (ID 2232)

      10:15 - 18:15  |  Author(s): Maurenis Hernandez

      • Abstract
      • Slides

      Background

      A Cuban therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides (CimaVax-EGF) induces antibodies against self EGF that decrease its concentration and affect EGF-EGFR interaction. Cimavax EGF was registered in Cuba as switch maintenance therapy for advanced stage NSCLC.

      Objective: Evaluate the safety an immunogenicity of the combination of cimavax and first-line chemotherapy in patients with inoperable stage IIIa non-small cell lung cancer

      Method

      A phase I clinical trial was conducted in two hospitals in Cuba, with the approval of Ethic Committee of each one. 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. First-line platinum-based chemotherapy was administered concomitantly, four to six cycles platinum-based ChT every 21 days.

      Result

      Thirty patients entered the study. Most frequently adverse events registered with the combined treatment were: injection-site reaction (7.8 %), cough (7.3%), anemia (6.1%), fever (5.3%), asthenia (4.9%) and anorexia (4.9%). Most of them were classified as grade1 -2 according CTCAE version 3. There were no deaths related to the combined treatment. Antibody response against EGF was repeatedly measured in 24 patients. More than 90% of patients (n = 23; 95,8%) were classified as good antibody responders (GAR). It was observed an inverse correlation between EGF concentrations and anti-EGF antibody titers, as previously Cimavax EGF trials have reported. Anti-EGF antibody titers continue increasing until day 76 during the chemotherapy course and was maintained until the end of the treatment. In fact, there were high anti-EGF antibodies post-chemotherapy than before. The median overall survival (mOS) time for all included patients was 9.4 months.

      Conclusion

      Cimavax EGF vaccine in combination with first-line platinum-based chemotherapy was a safe treatment option for NSCLC patients with IIIa stage NSCLC. Immune response was not affected with the administration of chemotherapy. This was the first combined study of Cimavax in locally advanced NSCLC.

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