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Tania Crombet



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    EP1.04 - Immuno-oncology (ID 194)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.04-23 - Ongoing Phase II Trial of Anti-PD1 Therapy in Combination with CIMAvax-EGF in Patients with Advanced NSCLC or Squamous Cell Head and Neck Cancer (Now Available) (ID 2668)

      08:00 - 18:00  |  Author(s): Tania Crombet

      • Abstract
      • Slides

      Background

      CIMAvax-EGF (CE) is a novel EGF-depleting immunotherapy consisting of human recombinant EGF conjugated to recombinant P64k derived from Neisseria meningitidis, that elicits an anti-EGF antibody response, resulting in reduction of circulating EGF levels. A randomized phase III study of CIMAvax-EGF administered after first-line platinum-based chemotherapy as switch maintenance therapy, in patients with advanced NSCLC, demonstrated improved overall survival versus best supportive care alone, particularly in patients with high baseline serum EGF levels. A recently completed phase I trial combining CE with nivolumab (N), an anti-PD1 immune checkpoint inhibitor, as second-line therapy for advanced NSCLC, demonstrated the combination is safe and induces a higher frequency of good anti-EGF antibody responses compared to the historical experience with CE alone (Figure 1). In addition, promising efficacy was observed in patients with PD-L1 low (< 1%) tumors. These results led to the initiation of this multi-arm phase II trial.

      figure 1.png

      Method

      CIMAvax-EGF (2.4 mg IM every 2 weeks x 4 doses, then every 4 weeks thereafter) in combination with Nivolumab (240mg IV every 2 weeks) is being evaluated in this multi-arm phase II study (NCT02955290) as second-line therapy in patients with advanced NSCLC (cohort A), advanced/recurrent head and neck squamous cell cancer (cohort B) and is also being tested as first-line therapy in combination with pembrolizumab (200 mg IV every 4 weeks) in patients with advanced NSCLC with PD-L1 ≥ 50% (cohort C). The primary and secondary endpoints are to evaluate 12-month OS and PFS in cohorts A and B, and to evaluate objective response rate, PFS and 12-month OS in cohort C. Exploratory objectives include characterizing tissue-based immune and EGFR signaling as well as serum EGF levels, anti-EGF antibody levels and other blood-based biomarkers in relation to clinical outcomes.

      Result

      A total of 10 patients have been enrolled to this ongoing study with a planned enrollment of up to 127 patients. An update on accrual along with interim safety, efficacy and correlative data will be presented.

      Conclusion

      To date, the combination of CIMAvax-EGF with anti-PD1 therapy has been safe and well tolerated. Enrollment to the phase II portion of this study is ongoing at Roswell Park and is in the process of being expanded to additional U.S. sites.

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • 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): Tania Crombet

      • 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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