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Silvia Novello



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    Early detection, screening, prevention (ID 7)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 4/10/2019, 14:30 - 16:00, Room C
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      Primary prevention European campaigns (Now Available) (ID 10)

      14:30 - 16:00  |  Presenting Author(s): Silvia Novello

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Mini Oral session I (ID 60)

    • Event: ELCC 2019
    • Type: Mini Oral session
    • Track:
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 4/11/2019, 08:00 - 08:50, Room A
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      115O - Afatinib in EGFR TKI-naïve patients (pts) with locally advanced/metastatic NSCLC harbouring EGFR mutations: An interim analysis of a phase IIIB trial (Now Available) (ID 361)

      08:00 - 08:50  |  Author(s): Silvia Novello

      • Abstract
      • Presentation
      • Slides

      Background

      First-line afatinib significantly improved progression-free survival (PFS) in pts with EGFR mutation-positive (EGFRm+) NSCLC (including uncommon mutations) vs chemotherapy (CT) in the LUX-Lung (LL) 3/6 trials (median 11.1 vs 6.9 mos; HR 0.58/11.0 vs 5.6 mos; HR 0.28) and vs gefitinib in LL7 (median 11.0 vs 10.9 mos; HR 0.73). However, in real-world (RW) practice CT remains a first-line choice. Here, we report an interim analysis of a Phase IIIb study of afatinib in treatment-naïve or CT pre-treated pts with EGFRm+ NSCLC, similar to RW practice.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      EGFR TKI-naïve pts with locally advanced/metastatic EGFRm+ NSCLC and ECOG PS 0–2 received 40 mg/day afatinib (starting dose). Dose reduction was permitted (to minimum 20 mg/day). Primary endpoint: adverse events (AEs) in a descriptive fashion. Efficacy was also assessed.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      At data cut-off (30 April 2018), 479 pts were enrolled and treated with afatinib (Caucasian/Asian/other: 97%/2%/<1%; male/female: 34%/66%; 1st/2nd/≥3rd-line therapy: 78%/17%/5%; ECOG PS 0/1/2: 36%/57%/8%; brain metastases: 17%; common/uncommon mutations: 87%/13%). Median time on afatinib was 359 days. The most common grade ≥3 afatinib-related AEs were diarrhoea (16%) and rash (11%). AEs led to dose reduction in 258 (54%) pts (most frequently diarrhoea 25%; rash 11%) and to afatinib discontinuation in 105 (22%) pts (most frequently diarrhoea 3% [rash 0.8%]). Afatinib-related serious AEs occurred in 39 (8%) pts. Time to symptomatic progression (TTSP) and PFS are shown in the table. Objective response rate and disease control rate were 46% and 86%, respectively.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Interim analysis of this study, which included pts treated with afatinib in later lines, and pts with ECOG PS 2, brain metastases and/or uncommon mutations, indicates a predictable and manageable safety profile for afatinib, consistent with the pivotal LL trials. Interim efficacy findings are encouraging, with a median TTSP of 14.9 months.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT01853826.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Robert Lorence of Boehringer Ingelheim assisted in the study concept, design and data analysis. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Jessica Sturgess of GeoMed, an Ashfield company, part of UDG Healthcare plc, during the development of this abstract.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Boehringer Ingelheim.

      213f68309caaa4ccc14d5f99789640ad Funding

      Boehringer Ingelheim.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Hochmair: Honoraria for speakers’ bureau, advisory role: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, MSD, Novartis, Pfizer, Roche. M.R. Migliorino: Board of directors, consulting fees: Boehringer Ingelheim, Roche, MSD, Bristol-Myers Squibb, AstraZeneca, Pfizer; Honoraria: Boehringer Ingelheim, Roche, MSD, Bristol-Myers Squibb, AstraZeneca, Pfizer, Gentili. S. Rizzato: Honoraria for Advisory board: AbbVie. G.Z. Mukhametshina: Employment: Republic Clinical Oncology Dispensary. S. Novello: Honoraria for speaker bureau/advisory roles: Eli Lilly, Celgene, AstraZeneca, Boehringer Ingelheim, MSD, Roche, Bristol-Myers Squibb. R. Dziadziuszko: Honoraria: Roche, Pfizer, Boehringer Ingelheim, AstraZeneca, Foundation Medicine, Novartis. W. Tang, L. Clementi, A. Cseh: Employment: Boehringer Ingelheim. F. De Marinis: Advisory council/committee membership: Roche, Pfizer Honoraria: Roche, Bristol-Myers Squibb, AstraZeneca; Grants/funds: Boehringer Ingelheim. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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