Author of

• 18337

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  P3.02a - Poster Session with Presenters Present (ID 470)

  • 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)

  • 18354

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    P3.02a-017 - Indirect Naive Comparison of Post-Crizotinib Treatments for ALK+ Non–Small-Cell Lung Cancer (NSCLC) (ID 4459)

    14:30 - 14:30  |  Author(s): J.T. Huang
    • Abstract

    Background:
    Comparing the efficacy of ALK inhibitors in post-crizotinib therapy of ALK+ NSCLC is hampered by the lack of comparator ALK inhibitor treatment arms in pivotal studies. An indirect naive comparison was undertaken to explore study results for the investigational ALK inhibitor brigatinib and the currently available agents alectinib and ceritinib following progression on crizotinib. Baseline characteristics were examined to determine if the distribution of prognostic factors differed across studies, and outcomes were compared.
    
    Methods:
    Patient characteristics and study outcomes (objective response rate [ORR], progression-free survival [PFS], duration of response [DOR], and adverse events [AEs]) for alectinib, brigatinib, and ceritinib were extracted from pivotal study publications identified in a systematic literature review, alectinib prescribing information, and brigatinib data in post-crizotinib settings. Outcomes were compared over the longest follow-ups reported.
    
    Results:
    All pivotal studies were multicenter and open label; populations were similar in median age, sex ratio, and baseline disease stage. Slight imbalances among studies exist in Eastern Cooperative Oncology Group/World Health Organization performance status and central nervous system metastases at baseline. ORR was numerically higher in the brigatinib phase 1/2 study for subjects receiving 180 mg once daily with 7-day lead-in at 90 mg versus other studies (Table). Median PFS and DOR were also higher in brigatinib studies versus alectinib and ceritinib studies; PFS 95% confidence intervals did not overlap between brigatinib and ceritinib studies. Rates of discontinuation due to AEs were similar across studies, but AE-related dose reductions were most frequent in ceritinib studies.Figure 1
    
    
    
    Conclusion:
    Pivotal trials for ALK inhibitors share many similarities, making an indirect comparison possible. Naive comparison suggests brigatinib may have a favorable efficacy profile compared with currently available therapies, while ceritinib may require dose reduction more frequently to manage AEs. Further analyses are needed to determine the magnitude and direction of potential bias.