Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

3352 - GECP 1605/NIVEX TRIAL. Nivolumab in the real world: the SPANISH expanded access program experience in pretreated advanced NSCLC


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research



Tumour Site


Margarita Majem Tarruella


Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292


M. Majem Tarruella1, J. Campillo2, J.F. Grau Béjar3, E. Carcereny4, R. Bernabe Caro5, Y. Garcia6, A. Artal-Cortes7, M. González Cao8, P. Lianes9, A. Paredes Lario10, M. Sereno Moyano11, X. Mielgo Rubio12, J.A. Macias13, M. Provencio Pulla14, D. Rodriguez-Abreu15

Author affiliations

  • 1 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 2 Medical Oncology, Hospital Virgen de la Arrixaca, Murcia/ES
  • 3 Medical Oncology Department, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 4 Hospital Germans Trias I Pujol, Catalan Institute of Oncology, Badalona/ES
  • 5 Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 6 Medical Oncology, Corporació Sanitaria Parc Taulí, Sabadell/ES
  • 7 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 8 Medical Oncology, QuironSalud Dexeus University Institute, IOR, 8028 - Barcelona/ES
  • 9 Medical Oncology Service, Hospital de Mataró, 08304 - Mataró/ES
  • 10 Medical Oncology, Hospital Donostia, 20080 - San Sebastian/ES
  • 11 Medical Oncology, Hospital Infanta Sofia, 28702 - Madrid/ES
  • 12 Medical Oncology, Hospital Universitario Fundación Alcorcón, 28922 - Madrid/ES
  • 13 Medical Oncology, Hospital Morales Messeguer, Murcia/ES
  • 14 Servicio De Oncología Médica, Hospital Universitario Puerta de Hierro - Majadahonda, 28222 - Majadahonda/ES
  • 15 Servicio Oncología Médica, Hospital Insular De Gran Canaria, Las Palmas/ES


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3352


Nivolumab is a standard treatment for second line in patients (pts) with advanced NSCLC. Real world data about toxicity and efficacy of nivolumab is lacking.


We have analyzed 665 pts from the Expanded Access Program, which included pts with pretreated NSCLC who received ≥1dose of nivolumab 3mg/kg q2w from 01/2015 for squamous (Sq) and 06/2015 for non‐Sq NSCLC, to 11/2017.


Median age was 61 (32-85) years, 73% were men, 85% had ECOG 0-1, 88% were current/former smokers and 15% had brain M1. 128 (19.2%) pts presented Sq and 537 (80.8%) Non‐Sq NSCLC. 7% of pts presented EGFR mutation. PD-L1 was ≥1% in 33% of analyzed pts. Nivolumab was administered as 2nd/≥3rd line in 33% and 67% of pts. Post-nivolumab treatment was administered to 25% pts that received nivolumab in 2nd line and to 23% that received nivolumab in 3rd line. 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 were observed according to histologies. Among pts that received nivolumab in 2nd line, the median OS was 9.8 (95% CI 7.3-12.0) months and the median PFS was 3.3 (95%CI 2.4-4.2) months. Among pts that received nivolumab in ≥ 3rd line the median OS was 8.6 (95% CI 7.2-10.0) months and the median PFS was 3.1 (95% CI 2.6-3.7) months. Median OS for pts that received post-nivolumab treatment in 3rd line was 9.3 (95 CI% 7.0-11.6) months. 296 (44.5%) pts presented toxicity to nivolumab, which was grade ≥3 in 69 (10.4%) pts. According to the presence of grade ≥3 toxicity, the median OS was 14.57 (CI 95% 8.45-20.68) months for pts with and 8.73 (CI 95% 7.50-9.96) months for pts without grade≥3 toxicity (p = 0.074). Additional efficacy and safety data, including PS2, brain M1, response to first line, or post-nivolumab treatment will be presented.


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

Clinical trial identification


Legal entity responsible for the study

Spanish Lung Cancer Group.



Editorial Acknowledgement


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.