Author of

• 25952

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  P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27247

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    P2.15-25 - NIVEX TRIAL (GECP 1605): Nivolumab in the Real World: Spanish Expanded Access Program Experience in Pretreated Advanced NSCLC Patients (ID 13030)

    16:45 - 18:00  |  Author(s): Yolanda Garcia
    • Abstract

    Background
    

    Nivolumab is a standard treatment for pretreated patients with advanced non-small cell lung cancer (NSCLC). Real world data about toxicity and efficacy of nivolumab is needed.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    We have analyzed patients from the Expanded Access Program in Spain that included patients with advanced pretreated NSCLC. We have retrospectively analyzed 665 patients that had received at least 1 dose of nivolumab 3mg/kg q2w from 01/2015 for squamous ﴾Sq﴿ and 06/2015 for non‐Sq NSCLC, to 11/2017.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Median age was 61 (32-85) years, 73% were men, 85% had ECOG 0-1, 88% were current or former smokers and 15% presented brain metastases. 128 (19,2%) patients presented Sq NSCLC and 537 (80,8%) patients Non‐Sq NSCLC. 7% of patients presented EGFR mutation. PD-L1 was ≥ 1% in 32,9% of analyzed patients.

    Best response was complete response 1,7%, partial response 22,4%, stable disease 24,1%, and progressive disease 37,1%, and was not assessed in 14,7% of patients. No differences in response rate were observed according to histology.

    After a median follow‐up of 8,2 months, the median OS was 8,97 (95%CI 7,69-10,24) months, and the median PFS was 3,23 (95%CI 2,77-3,70) months. Estimated 1-year OS was 42,4% (95%CI 38,5-42,8%) and estimated 1-year PFS was 22,2% (95%CI 19,1-25,3%). No differences in OS or PFS according to histologies were observed.

    296 (44,5%) patients presented toxicity related to Nivolumab, that was grade ≥3 in 69 (10,4%) patients. Grade ≥3 diarrhea was reported in 1,2% of patients and pneumonitis occurred in 1,2% of patients (1 patient presented a grade 5 pneumonitis). According to the presence of grade ≥3 toxicity, the median OS was 14,57 (CI95% 8,45-20,68) months for patients with grade ≥3 toxicity and 8,73 (CI95% 7,50-9,96) months for patients without grade ≥3 toxicity (p= 0,074).

    Additional efficacy data including treatment lines, presence of immune-related adverse events, PS2, brain metastasis, response to first line, or post-nivolumab treatment will be presented.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Efficacy and safety of nivolumab was in line with previously shown data. There was a trend to a better OS for those patients experiencing grade ≥3 toxicity.

    6f8b794f3246b0c1e1780bb4d4d5dc53