Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Nivolumab in patients with previously treated metastatic squamous non-small cell lung cancer (NSCLC): Results of a European single-arm, phase 2 trial (CheckMate 171) including patients aged ≥70 years or with poor performance status (#228)

Sanjay Popat 1 , Andrea Ardizzoni 2 , Tudor Ciuleanu 3 , Manuel Cobo Dols 4 , Konstantin Laktionov 5 , Maria Szilasi 6 , Raffaele Califano 7 , Enric Carcereny Costa 8 , Richard Griffiths 9 , Luis Paz-Ares 10 , Cezary Szczylik 11 , Jesus Corral Jaime 12 , Dolores Isla 13 , Jacek Jassem 14 , Wiebke Appel 15 , Jan van Meerbeeck 16 , Jürgen Wolf 17 , Joel Jiang 18 , L. Rhoda Molife 18 , Enriqueta Felip 19 , Simone Meuter 20 , Kelley Palmer
  1. Royal Marsden Hospital, London, UK
  2. Policlinico Sant’Orsola – Malpighi, Bologna, Italy
  3. The Oncology Institute Prof. Dr. Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania
  4. Hospital Regional Universitario de Malaga, Malaga, Spain
  5. N.N. Blokhin Russian Cancer Research Center, Moscow, Russia
  6. Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary
  7. The Christie NHS Foundation Trust, Manchester, UK
  8. Instituto Catalan de Oncologia (ICO Badalona), Barcelona, Spain
  9. The Clatterbridge Cancer Centre, Bebington, UK
  10. Hospital Universitario 12 de Octubre, Madrid, Spain
  11. Wojskowy Instytut Medyczny, Warsaw, Poland
  12. Virgen del Rocio University Hospital, Seville, Spain
  13. University Hospital Lozano Blesa, Zaragoza, Spain
  14. Medical University of Gdansk, Gdansk, Poland
  15. Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK
  16. Antwerp University Hospital, Edegem, Belgium
  17. Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany
  18. Bristol-Myers Squibb, Princeton, NJ, USA
  19. Vall d’Hebron Institute of Oncology, Barcelona, Spain
  20. Bristol-Myers Squibb, Mulgrave, VIC, Australia

Aims:

Nivolumab, a fully human anti-programmed death-1 antibody, demonstrated improved overall survival (OS) and a favorable safety profile versus docetaxel in previously treated advanced squamous NSCLC in a phase 3 trial (CheckMate 017). Here, we present findings from a single-arm phase 2 study of nivolumab in patients with previously treated advanced squamous NSCLC (CheckMate 171; NCT02409368).

Methods:

Patients aged ≥18 years from 13 European countries, with advanced squamous NSCLC, progressive disease after ≥1 systemic treatment, and ECOG performance status (PS) 0–2 were eligible to receive nivolumab. The primary objective was safety evaluation; OS was a secondary objective.

Results:

Of 809 patients enrolled, 79% were male and 93% were current/former smokers. Most patients had received 1 (42%) or 2 (40%) prior lines of therapy. Median (range) duration of nivolumab therapy was 4.4 (0-14.7+) months. At database lock, 324 (40%) patients were continuing treatment. Treatment-related adverse events (TRAEs) occurred in 403 (50%) patients, including grade 3–4 TRAEs in 95 (12%) patients, most frequently asthenia (n=12, 2%) and fatigue (n=10, 1%). Five (1%) patients had treatment-related grade ≥3 pneumonitis. Forty-five (6%) patients discontinued due to TRAEs, most commonly pneumonitis (n=7), asthenia (n=5), and fatigue (n=5); 3 deaths were considered treatment-related. Median OS was 9.9 months (95% CI: 8.7, 13.1). Of 279 patients aged ≥70 years, 155 (56%) had TRAEs and 16 (6%) discontinued due to TRAEs. Of 98 patients with ECOG PS=2, 45 (46%) had TRAEs and 5 (5%) discontinued due to TRAEs. Additional data including outcomes in these two subgroups will be presented.

Conclusions:

The safety of nivolumab in this study was consistent with prior studies of nivolumab in previously treated squamous NSCLC, with no new safety signals. Tolerability in patients aged ≥70 years or with ECOG PS=2 was comparable to the overall population.