Author of

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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
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30602

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    P2.01-01 - Cemiplimab, a Human PD-1 Monoclonal Antibody, Versus Chemotherapy in First-Line Treatment of Advanced NSCLC with PD-L1 ≥50% (ID 1380)

    10:15 - 18:15  |  Author(s): Virote Sriuranpong
    • Abstract
    • Slides

    Background
    

    Most patients (pts) with non-small cell lung cancer (NSCLC) present with advanced disease at diagnosis. Despite initial response to platinum-based doublet chemotherapy, an established first-line treatment for pts with advanced NSCLC whose tumours do not have EGFR, ALK, or ROS 1 mutations, pts often progress and require additional treatment options. In recent years, anti-programmed death-1 (anti–PD-1) therapies have emerged as an effective treatment option for advanced NSCLC, potentially allowing some patients with PD-L1 expression ≥50% to avoid chemotherapy. However, there is currently only one PD-1 inhibitor approved as monotherapy in first-line treatment of NSCLC. In a Phase 1 trial of pts with advanced malignancies, including NSCLC, cemiplimab exhibited anti-tumour activity with a safety profile similar to those described for other anti–PD-1 agents. Cemiplimab-rwlc is the only Food and Drug Administration-approved treatment for patients with advanced cutaneous squamous cell carcinoma.

    Method
    

    This is a randomised (1:1), multicentre, open-label, Phase 3 study of cemiplimab versus platinum‑based doublet chemotherapy in systemic treatment‑naïve pts (≥18 years) with stage IIIB, IIIC or IV squamous or non‑squamous NSCLC whose tumours express PD‑L1 in ≥50% of tumour cells (NCT03088540). Pts will be stratified by histology and geographic region. Pts will receive cemiplimab 350 mg every 3 weeks intravenously (for up to 108 weeks) or 4–6 cycles chemotherapy with (i) paclitaxel + cisplatin or carboplatin, (ii) pemetrexed + cisplatin or carboplatin with or without pemetrexed maintenance, (iii) or gemcitabine + cisplatin or carboplatin. Crossover from chemotherapy to cemiplimab and addition of chemotherapy to cemiplimab at the time of disease progression is allowed. The primary objective is to evaluate progression-free survival (PFS) as determined by blinded independent review committee. Key secondary objectives include assessment of overall survival and objective response rate. An independent data monitoring committee will monitor safety data during study conduct.

    Result
    

    Section not applicable

    Conclusion
    

    Section not applicable

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