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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

Date

20 Oct 2018

Session

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

Topics

Immunotherapy

Tumour Site

Presenters

Margarita Majem Tarruella

Citation

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

Authors

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
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Resources

Abstract 3352

Background

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.

Methods

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.

Results

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.

Conclusions

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

NCT03132493.

Legal entity responsible for the study

Spanish Lung Cancer Group.

Funding

BMS.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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