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Poster Display

1984 - Preliminary efficacy and safety data of nivolumab in never smoker patients with advanced squamous NSCLC: Experience from Italian sites participating in the Expanded Access Programme (EAP)


08 Oct 2016


Poster Display


Milena Vitali


Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383


M. Vitali1, L. Crinò2, A.F. Logroscino3, A. Ardizzoni4, S. Caponnetto5, L. Landi6, P. Bordi7, C. Luana8, F. Barbieri9, A. Santo10, M. Santarpia11, G. Carteni12, E. Mini13, E. Vasile14, F. Morgillo15, F. De Galitiis16, R. Conca17, M. Macerelli18, N. Tedde19, F. Vitiello20

Author affiliations

  • 1 Medical Oncology 1, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milano/IT
  • 2 Oncologia Medica, Ospedale S. Maria della Misericordia, 06156 - Perugia/IT
  • 3 Medical Oncology, Istituto Oncologico Bari, Bari/IT
  • 4 Medical Oncology, Policlinico S. Orsola-Malpighi, Bologna/IT
  • 5 Medicina Sperimentale, Policlinico Umberto I, 00161 - Roma/IT
  • 6 Medical Oncology, Ospedali Riuniti Livorno, Livorno/IT
  • 7 Medical Oncology, Azienda Ospedaliera di Parma, Parma/IT
  • 8 Medical Oncology, Azienda Ospedaliera Universitaria Senese - Santa Maria delle Scotte, Siena/IT
  • 9 Medical Oncology, Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena/IT
  • 10 Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", Verona/IT
  • 11 Medical Oncology, AOU Policlinico G. Martino Università di Messina, Messina/IT
  • 12 Medical Oncology, Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"-AORN A. Cardarelli, Napoli/IT
  • 13 Medical Oncology, Azienda Ospedaliera Universitaria Careggi, Firenze/IT
  • 14 Medical Oncology, Azienda Ospedaliera Universitaria S.Chiara, Pisa/IT
  • 15 Medical Oncology, AOU Seconda Università degli Studi di Napoli (AOU-SUN), Napoli/IT
  • 16 Medical Oncology, Istituto Dermopatico dell'Immacolata, Roma/IT
  • 17 Medical Oncology, Ospedale della Misericordia, Grosseto/IT
  • 18 Medical Oncology, Azienda Ospedaliera Universitaria-Udine Sta Maria della Misericordia, Udine/IT
  • 19 Medical Oncology, ASL Olbia, Olbia/IT
  • 20 Medical Oncology, Azienda Ospedaliera Dei Colli-Monaldi, Napoli/IT


Abstract 1984


Nivolumab is the first checkpoint inhibitor approved for the treatment of squamous non-small cell lung cancer (Sq-NSCLC) to show a survival benefit in a randomised phase III trial. In prior studies nivolumab has shown a better clinical benefit in current and former smokers compared to never smokers. Nevertheless, no data are available from a real world setting. The EAP provided an opportunity to evaluate the feasibility of treatment in this patient population outside of a controlled clinical trial in Italy.


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


Of 372 patients with Sq-NSCLC participating in the EAP in Italy, 38 (10.2%) were never smokers, in line to what observed in the registrational study Checkmate 017 (10%). With a median number of doses 8 (range, 1–22) and a median follow-up of 5.6 months, the disease control rate was 50%, including 9 patients with a partial response and 10 with stable disease. Eight pts were treated beyond RECIST defined progression, with 4 of these pts achieving a disease control. As of April 2016, median progression-free survival and overall survival were 3.5 months and not reached, respectively. Among 38 pts, 17 pts (44.7%) discontinued treatment for any reason except toxicity; 5 out of 38 discontinued due to AE (13.1%).


With the limitation of a small sample size and type of study (EAP), these data seem to suggest that nivolumab might have a similar efficacy in non-smoker patients to that observed in the overall population, warranting further investigation in this area.

Clinical trial identification


Legal entity responsible for the study





All authors have declared no conflicts of interest.

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