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Poster display session

2760 - Italian nivolumab expanded access programme in non-Squamous non-small cell lung cancer patients: real-world results in never smokers and EGFR positive patients.


09 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Non-Small Cell Lung Cancer


Marina Garassino


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


M. Garassino1, E. Cortesi2, F. Grossi3, R. Chiari4, H.J. Soto Parra5, S. Cascinu6, F. Cognetti7, D. Turci8, L. Blasi9, C. Bengala10, E. Mini11, E.E. Baldini12, T. Gamucci13, G.L. Ceresoli14, P. Antonelli15, E. Vasile16, M. Pagano17, M. Macerelli18, A. Lagroscino19, F. De Marinis20

Author affiliations

  • 1 Oncology, Isituto Nazionale dei Tumori, 20133 - Milano/IT
  • 2 Medical Oncology Unit, Policlinico Umberto I, 161 - Roma/IT
  • 3 Medical Oncology Unit, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 4 Medical Oncology, Azienda Ospedaliera di Perugia, 06129 - Perugia/IT
  • 5 Medical Oncology, AOU Policlinico Vittorio EManuele, 95123 - Catania/IT
  • 6 Department Of Medical And Surgical Sciences For Children & Adults, Università degli studi di Modena e Reggio Emilia, 41124 - Modena/IT
  • 7 Medical Oncology Unit, IFO Regina Elena, 00144 - Roma/IT
  • 8 Medical Oncology Unit, Umberto I Hospital, 48400 - Ravenna/IT
  • 9 Medical Oncology Unit, Ospedale Civico, 90127 - Palermo/IT
  • 10 Medical Oncology Unit, 10USL Presidio Ospedaliero Misericordia, 58100 - Grosseto/IT
  • 11 Medical Oncology Unit, AOU Careggi, 50141 - Firenze/IT
  • 12 Medical Oncology Unit, USL 2 Lucca, 55100 - Lucca/IT
  • 13 Oncologia Medica, Ospedale SS Trinità, 03039 - Sora/IT
  • 14 Department Of Oncology, Humanitas Gavazzeni, 24125 - Bergamo/IT
  • 15 Medical Oncology Unit, 15ASST Valle Olona, Ospedale di Circolo, 21052 - Busto Arsizio/IT
  • 16 Unit Of Medical Oncology, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 17 Medical Oncology Unit, IRCCS ASMN Reggio Emilia, 42123 - Reggio Emilia/IT
  • 18 Clinical Oncology, ASUIUD Santa Maria della Misericordia, 33100 - UDINE/IT
  • 19 Medical Oncology Unit, Istituto Tumori Giovanni Paolo II, 70124 - Bari/IT
  • 20 Oncologia, Istituto Europeo di Oncologia, 20141 - Milano/IT


Abstract 2760


Nivolumab is the first checkpoint inhibitor approved for the treatment of non-Squamous non-small cell lung cancer (non-Sq-NSCLC). In previous studies, a greater clinical benefit was shown in current and former smokers than in never smokers and in EGFR mutated patients (pts). Nevertheless, no data are available from a real-world setting. Here we report the data from Italian expanded access program (EAP) in the never smoker pts and EGFR mutated pts.


Nivolumab was provided upon physicians’ request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for ≤24 months. Pts included in the analysis received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.


Of 1588 patients with non-Sq-NSCLC, 305 (19%) were never smokers and, among 1455 pts evaluable for EGFR mutation, 102 (7%) were positive. In the never smoker group, EGFR status was available for 287 pts, with 51 (19%) who harbored an activating EGFR mutation. Among never smokers, with a median follow-up (FU) of 7.0 months (0.1-20.3) and a median of 7 doses (1-38), the objective response rate (ORR), the disease control rate (DCR) and the median overall survival (OS) were 9%, 42% and 10.0 months (8.1-11.9), respectively. Among all EGFR positive pts, with a median FU of 5.5 months (0.1-20.9) and a median of 6 doses (1-40), the ORR, DCR and median OS were 9%, 30% and 8.3 months (2.2-14.4), respectively. In the never smoker group, EGFR positive pts had 2% ORR, 26% DCR and 5.6 months (3.4-7.8) of median OS. However, it should be considered that these pts had poorer prognostic factors (ECOG performance status, brain metastasis) at baseline.


These preliminary results represent the first real-life data regarding the efficacy of nivolumab in special subpopulations, including never smokers and EGFR positive pts. Even if ORR and OS seem lower than in general population, due to lack of alternatives and good safety profile, nivolumab should be considered as a therapeutic option.

Clinical trial identification

CA209 966

Legal entity responsible for the study

Lucio Crinò




M.C. Garassino: Potential conflict of interest with: Bristol-Myers Squibb, Roche, AstraZeneca. H.J. Soto Parra: Advisory board of: AstraZeneca, Bristol-Myers Squib, Lilly, MSD, Merck Sharp & Dohme AG. F. De Marinis: Potential COI with: Boehringer Ingelheim, MSD, AstraZeneca, BMS, Celgene, Novartis, Pfizer, Roche/Genentech, Pierre-Fabre All other authors have declared no conflicts of interest.

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