Author of

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  P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall

  • 27536

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    P3.04-25 - EMPOWER-Lung 3: A Phase 3 Study of Cemiplimab, Ipilimumab and Chemotherapy in Advanced NSCLC with PD-L1 <50% (ID 13347)

    12:00 - 13:30  |  Author(s): Sue Lee
    • Abstract
    • Slides

    Background
    

    Immune checkpoint inhibitors have shown activity in NSCLC, but the benefit is mostly seen in patients with tumor proportion score (TPS) ≥50%. Patients with TPS <50% will likely require a combination therapy approach. Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, has exhibited antitumor activity and safety in a phase 1 trial of advanced malignancies including NSCLC. Based on their unique modes of action, combining cemiplimab with ipilimumab, an anti‑CTLA‑4, and modified platinum‑based chemotherapy has the potential for a synergistic effect in patients with advanced NSCLC with PD-L1 <50%.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    EMPOWER-lung 3 (16113) is a randomized (1:1:1), open-label, global, phase 3 study of the efficacy and safety of combinations of cemiplimab, ipilimumab, and platinum-based doublet chemotherapy in the first-line treatment of patients with advanced or metastatic NSCLC with tumors expressing PD-L1 <50% (NCT03409614). Patients will be stratified by histology and PD-L1 expression level (<1% vs 1–24% vs 25–49%). Treatment arms: Arm A: standard of care platinum‑based doublet chemotherapy every 3 weeks (Q3W) for 4–6 cycles; Arm B: cemiplimab Q3W (up to 108 weeks) plus standard of care platinum-based doublet chemotherapy Q3W for 4–6 cycles; Arm C: cemiplimab Q3W (up to 108 weeks) plus standard of care platinum-based doublet chemotherapy Q3W for two cycles and ipilimumab 50 mg every 6 weeks (up to 4 doses). The primary objective is to evaluate progression-free survival (PFS). Key secondary objectives include overall survival and overall response rate. A total of 690 patients are planned. This assumes a median PFS of 6 months for patients treated with chemotherapy alone and 10 months for patients treated with each of the cemiplimab combination therapies, corresponding to a 66.7% increase in median PFS and a hazard ratio of 0.6. Under these assumptions, the planned enrollment will generate sufficient PFS events for analysis of PFS with 90% power to detect a statistical significant difference for each of cemiplimab combination vs standard of care platinum-based doublet chemotherapy comparison. Enrollment has begun for this study.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Section not applicable

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Section not applicable

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