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R. Gaafar

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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      157P - Second-line afatinib for patients with locally advanced or metastatic NSCLC harbouring common EGFR mutations: A phase IV study (ID 198)

      12:30 - 13:00  |  Author(s): R. Gaafar

      • Abstract
      • Slides

      The oral, irreversible ErbB family blocker, afatinib, is approved as first-line treatment for patients with EGFR mutation-positive (EGFRm+) NSCLC, demonstrating superior progression-free survival (PFS) and tolerability versus platinum-based chemotherapy. However, chemotherapy is still commonly used as first-line therapy in this patient population. In the LUX-Lung 2 study, second-line afatinib demonstrated clinical activity and an acceptable safety profile in patients with advanced NSCLC harbouring common EGFR (Del19/L858R) mutations following chemotherapy; however, the starting dose was 50 mg/day for most patients. Here, we report efficacy and safety of second-line afatinib at the approved dose of 40 mg/day in this patient population.

      In this open-label, single-arm Phase IV study, tyrosine kinase inhibitor-naïve patients with EGFRm+ (Del19/L858R) NSCLC who progressed after failure of first-line chemotherapy received afatinib (starting dose 40 mg/day) until disease progression or other reasons necessitating withdrawal. The primary endpoint was investigator-assessed objective response (OR); secondary endpoints were PFS and disease control. Safety was also assessed.

      The study was conducted across 24 sites in 7 countries. Sixty patients were enrolled into the study and treated with afatinib for a median duration of 11.5 months. The mean age of patients was 55.9 years; 55% were female. An OR was achieved by 50% of treated patients; median duration of response was 13.8 months. 50 patients achieved disease control; median duration was 11.9 months. 39 patients experienced an event contributing to PFS, with median PFS of 10.9 months. The most common treatment-related adverse events were diarrhoea (72%), rash/acne (58%), and paronychia (27%); no deaths were related to afatinib treatment.

      At the approved starting dose of 40 mg/day, second-line afatinib demonstrated efficacy and a tolerable safety profile in patients with EGFRm+ (Del19/L858R) NSCLC. The outcomes are consistent with previous studies of afatinib. These findings support the use of second-line 40 mg/day afatinib in chemotherapy pre-treated patients.

      Clinical trial identification:

      Legal entity responsible for the study:
      Boehringer Ingelheim

      Boehringer Ingelheim

      S. Geater: Honoraria from AstraZeneca and Boehringer Ingelhiem, Research funding from Samsung, AstraZeneca, Boehringer Ingelhiem and Roche. D. Jovanovic: Membership on an advisory board or board of directors: Member of local and regional (Adriatic) BI AdB. R. Gaafar: Membership of advisory board: Boehringer Ingelheim, EliLilly, Astra Zeneca, MSD, Corporate sponsored research between company and NCI, Cairo University and investigator Roche International, BI, MsD. All other authors have declared no conflicts of interest.

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