Author of

• 25941

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  P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27003

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    P2.04-26 - Interim Results from a Phase I/II Trial of Nivolumab in Combination with CIMAvax-EGF as Second-Line Therapy in Advanced NSCLC (ID 13359)

    16:45 - 18:00  |  Author(s): Danay Saavedra
    • Abstract

    Background
    

    CIMAvax-EGF (CE), a recombinant anti-human epidermal growth factor (EGF) vaccine, has demonstrated survival benefit as maintenance therapy in advanced NSCLC. We report the results from the dose-escalation phase I portion of the study investigating CE in combination with Nivolumab(N) in patients (pts) with advanced stage, previously treated immunotherapy-naïve NSCLC.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This is an open-label phase I dose-escalation study with a 3+3 design. Intramuscular CE is investigated in two dose levels (1.2 and 2.4 mg, given q 2 weeks x 4 doses during the induction phase, then q monthly during the maintenance phase) in combination with 240 mg iv N q 2 weeks. Pts remain on treatment until disease progression, serious toxicity or consent withdrawal. The primary objective is to determine the safety and recommended phase II dose (RP2D) of CE in combination with N. Secondary objectives include tumor response and correlative markers of immune response. Toxicities are graded according to CTCAE v4.03. No intra-pt dose escalation is allowed

    4c3880bb027f159e801041b1021e88e8 Result
    

    9 pts have completed DLT assessments (7Female: 2Male). Median age is 58 (range 46-69). All pts have EGFR, KRAS and ALK wildtype NSCLC. Adenocarcinoma is the predominant histologic subtype (7/9). One pt had Gr 3 myocarditis (LVEF 25%-30%) attributed to N alone on Cycle 1 day 8 and taken off study. LVEF improved (60%-65%) but pt eventually had Gr 5 brain hemorrhage due to brain metastasis, unrelated to treatment, on Cycle 1 day 29. No other treatment-related CTC grade 3+ AEs attributed to either N and/or CE. The RP2D dose was established at 2.4 mg for CE. Objective response rate of 44% was seen (4 PRs: 3 adenocarcinoma, 1 squamous; 3 PD-L1 <1%, 1 PD-L1 60%). There is a significant inverse correlation (p<0.001) between the temporal change in anti-EGF Ab titers and the change in serum EGF levels based upon a generalized linear model. 71% of pts (95% CI 36%-92%) achieved an anti-EGF Ab titer of > 1:4000 after 3 vaccine doses by day 43. We will present additional information on safety, efficacy profile and correlative data in the meeting

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Combination of N+CE did not show unexpected toxicities. Preliminary efficacy and immunological data warrant further investigation.

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