Author of

• 18374

  +

  P3.02b - Poster Session with Presenters Present (ID 494)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18419

    +

    P3.02b-045 - Patritumab plus Erlotinib in EGFR Wild-Type Advanced Non–Small Cell Lung Cancer (NSCLC): Part a Results of HER3-Lung Study (ID 5473)

    14:30 - 14:30  |  Author(s): P. Serwatowski
    • Abstract
    • Slides

    Background:
    Patritumab is a fully human monoclonal antibody that inhibits human epidermal growth factor receptor 3. In a subgroup analysis of the phase 2 HERALD study, addition of patritumab to erlotinib increased progression-free survival (PFS) in advanced NSCLC patients with high tumor expression of heregulin mRNA (HRG-High); a similar safety profile was seen with patritumab+erlotinib versus erlotinib. This 2-part, phase 3 study (HER3-Lung) investigated erlotinib±patritumab in advanced, EGFR wild-type NSCLC patients previously treated with a platinum doublet. The primary objective of Part A was to confirm PFS improvement in HRG-High subjects.
    
    Methods:
    HER3-Lung was a 2-part, randomized, placebo-controlled, double-blind study. Subjects aged ≥20 years with known HRG expression, advanced NSCLC previously treated with 1–2 systemic therapies including a platinum doublet, and EGFR wild-type (if adenocarcinoma histology) were eligible. Subjects were stratified by HRG expression, histology subtype (adenocarcinoma, squamous-cell carcinoma/NOS), ECOG performance status (0–1), and best response to most recent therapy (CR/PR/SD, PD). Within each stratum, subjects were randomized 1:1 to erlotinib+patritumab or erlotinib+placebo.
    
    Results:
    One-hundred forty-five subjects were randomized, and 125 had discontinued study treatment prior to the data cutoff date. Most common reason for discontinuation was progressive disease (n=70). In the erlotinib+patritumab and erlotinib+placebo arms, respectively, treatment-emergent adverse events (TEAEs) grade ≥3 were reported in 40.5% and 46.5% and any grade serious TEAEs in 35.1% and 36.6% of subjects. Most common TEAEs (by subject) in the erlotinib+patritumab and erlotinib+placebo arms, respectively, were diarrhea (51.4%, 31%) and rash (37.8%, 36.6%). Patritumab did not increase erlotinib efficacy in the intent-to-treat group or HRG subgroups (Table). The study was stopped at the end of Part A because efficacy criteria to proceed into Part B were not reached.
    
    Conclusion:
    HER-3Lung did not confirm patritumab efficacy in the HRG-High subgroup. Safety of patritumab in combination with erlotinib was acceptable.Figure 1
    
    
    
    

    Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.