Author of

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  P2.04 - Immuno-oncology (ID 167)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Immuno-oncology
  • Presentations: 1
  • Now Available
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30995

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    P2.04-45 - A Phase 1b Dose-Escalation Study of Carotuximab in Combination with Nivolumab in Patients with Metastatic NSCLC (Now Available) (ID 926)

    10:15 - 18:15  |  Author(s): Alicia A Trigeiro
    • Abstract
    • Slides

    Background
    

    Nivolumab has demostrated clinical benefit in advanced non-small cell lung cancer (NSCLC) patients who have progressed following platinum-based chemotherapy.Carotuximab (TRC105) is an antibody to endoglin, a receptor expressed on proliferating endothelial cells and myeloid derived suppressor cell (MDSCs), which potently complements the activity of antibody targeting the programmed death receptor (PD-1) in preclinical models. By targeting MDSCs, carotuximab has the potential to complement nivolumab in patients with refractory metastatic NSCLC.

    Method
    

    Patients with refractory metastatic NSCLC were enrolled regardless of baseline PD-L1 tumor expression and treated with 8 mg/kg or 10 mg/kg of carotuximab weekly for four doses and then 15 mg/kg every two weeks, in combination with the approved dose of nivolumab of 240 mg every two weeks using a standard "3+3" dose escalation design. Expansion cohorts were then opened to further assess the safety, tolerability, and preliminary efficacy by iRECIST of the recommended Phase 2 dose (RP2D) of carotuximab with standard dose nivolumab.

    Result
    

    The combination of carotuximab and nivolumab was well-tolerated without dose limiting toxicitiy in 6 patients treated as part of dose escalation. One of these 6 patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 14 months. Two of the other 5 patients, one of whom who progressed following prior nivolumab treatment, achieved stable disease, one of whom remains on study at 7 months.. Common adverse events regardless of relationship included low grade headache, vomiting, anemia, dyspnea, fatigue, cutaneous telangectasia, nausea, bleeding gums, diarrhea, and migraine. Target concentrations of carotuximab were achieved in all patients and anti-drug antibody was not detected. Enrollment is continuing in two parallel 12 patient expansion cohorts, one in patients who relapsed following prior PD-1/PD-L1 checkpoint inhibition and one in patients naive to PD-1/PD-L1 checkpoint inhibition.

    Conclusion
    

    Carotuximab at its RP2D of 10 mg/kg weekly x 4 and then 15 mg/kg every 2 weeks was tolerable with nivolumab in patients with NSCLC, and demonstrated preliminary signs of efficacy

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