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Poster display session

3154 - Real life experience with nivolumab in patients (pts) with advanced non-squamous NSCLC (nSq-NSCLC) exhibiting KRAS mutations: the Italian Expanded Access Program (EAP)


09 Sep 2017


Poster display session


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


Federico Cappuzzo


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


F. Cappuzzo1, P. Bidoli2, R. Chiari3, A. Chirco4, D. Turci1, A. Ardizzoni5, A. Santoro6, C. Natoli7, G. Francini8, M. Giordano9, G. Borra10, C. Defferrari11, L. Livi12, A. Berruti13, M. Minelli14, E. Ricevuto15, A. Illiano16, G. Puppo17, A. Delmonte18, A. Misino19

Author affiliations

  • 1 Oncology And Hematology, Ospedale Civile di Ravenna - S.ta Maria delle Croci, 48121 - Ravenna/IT
  • 2 Oncology And Hematology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, 20052 - Monza/IT
  • 3 Medical Oncology, Azienda Ospedaliera di Perugia, 06129 - Perugia/IT
  • 4 Oncology And Hematology, Ospedale Papa Giovanni XXIII, Bergamo/IT
  • 5 Medical Oncology, University Hospital Sant'Orsola, Bologna/IT
  • 6 Oncology And Hematology, Istituto Clinico Humanitas, 20089 - Rozzano/IT
  • 7 Oncology And Hematology, P.O. Clinicizzato Ss. Annunziata Universita' Degli Studi, 66100 - Chieti/IT
  • 8 Oncology, Unità Sanitaria Locale 7 Siena, 53100 - Siena/IT
  • 9 Oncology, Presidio Ospedaliero Ospedale Sant'Anna, 22100 - San Fermo della Battaglia/IT
  • 10 Oncology, AOU Maggiore della Carità di Novara, novara/IT
  • 11 Oncology, 6Ospedali Galliera, Genova, Genova/IT
  • 12 Radioterapia, Azienda Ospedaliera Universitaria Careggi, Florence/IT
  • 13 Medical Oncology, University of Brescia, Spedali Civili, Brescia/IT
  • 14 Oncology, ospedale San Giovanni Addolorata, Roma/IT
  • 15 Oncology, Rete Oncologica ASL1 Abruzzo, L'Aquila/IT
  • 16 Oncology, AO del Colli, Monaldi-Cotugno-CTO, Napoli/IT
  • 17 Oncology, AOU Pisana, Pisa/IT
  • 18 Department Of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola/IT
  • 19 Oncology, Istituto Tumori Giovanni Paolo II, 70126 - Bari/IT


Abstract 3154


Nivolumab has been approved by different regulatory agencies worldwide for the treatment of nSq-NSCLC based on its superiority in Overall Survival (OS) versus docetaxel in CheckMate 057 trial. In a pre-specified subgroup analysis of the same trial, this advantage was confirmed also in KRAS-mutation+ pts but the small number precluded any definitive conclusion. The Italian nivolumab EAP for non-sq-NSCLC might represent an important source of information in that respect. The current analysis describes results of the use of nivolumab in the group of EAP pts with KRAS mutations.


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.


In total, 1588 Italian pts with advanced nSq-NSCLC received at least one dose of nivolumab in the EAP across 168 sites. Among pts evaluated for KRAS mutation, 206 (39%) resulted positive. In this subgroup of pts, with a median follow-up of 7.7 months (0.1-21.2) and a median number of 8 doses (1-45), the best overall response rate (BORR) was 20%, including 2 pts with complete response and 39 pts with partial response, and the median OS was 10.7 months (8.6-12.8). These results were in line with those ones showed in the overall population (18% BORR and 11 months median OS, respectively).


This analysis confirms, in a real word setting and in a much larger number of pts, the efficacy of nivolumab in KRAS-positive pts in CheckMate 057. Nivolumab represents a potentially effective therapeutic option for KRAS mutation, a molecular alteration for which there is currently no direct targeted therapy.

Clinical trial identification


Legal entity responsible for the study

Lucio Crinò




F. Cappuzzo: Consultant and participation in advisory boards for BMS, Roche, Pfizer, AZ. All other authors have declared no conflicts of interest.

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