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Orestes Santos Morales



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-84 - High Basal Serum EGF Levels Predicts Response to CIMAvax-EGF, a Therapeutic Vaccine for Advanced NSCLC (ID 14045)

      16:45 - 18:00  |  Presenting Author(s): Orestes Santos Morales

      • Abstract
      • Slides

      Background

      CIMAvax-EGF is a therapeutic vaccine for the treament of advanced NSCLC. The rationale of its use is to create an immune response against circulating plasmatic EGF and by doing this prevent its binding to EGFR. Previous early stage trials have shown its safety and efficacy. Recently a randomized controlled phase III pivotal trial have confirmed its efficacy and safety in open population when used according to stablished protocols. Exploratory results from this study suggested EGF could function as prognostic and predictive biomarker. In this study we aim to evaluate whether basal EGF plasmatic levels can predict patients response to this immunotherapeutic product.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      To know the effect of biomarker status on CIMAvax-effect we pooled data from two previously published controlled trials that used the product in a population of advanced non small cell lung cancer after First Line platinum based chemotherapy. Low doses of cyclophosphamide (200mg/m2) were administered IV three days before the first administration of the vaccine. 2.4 mg/dose of the product were administered during induction phase and then monthly for maintenance treatment. Both studies used Best Support Care as Control Arm. The main outcome was Overall Survival.

      4c3880bb027f159e801041b1021e88e8 Result

      Out of 485 patients included in both studies, 229 were screening for EGF levels (56.5%), (120 and 109 in the high and low level subgroup, respectively). All patients were considered in the analyses. A significant biomarker/treatment effect was found (p=0.000). Hazard ratio (CIMAvax-EGF vs BSC) in the high egf subgroup favoured CIMAvax-EGF (0.44, p=0.000).

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      8eea62084ca7e541d918e823422bd82e Conclusion

      Basal level of plasmatic EGF predicts clinical benefit from CIMAvax-EGF therapeutic cancer vaccine in advanced NSCLC after First Line of Treatment based on Platinum. Vaccinated patients in the subgroup of high EGF levels significantly benefit from CIMAvax-EGF.

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