Five-year follow-up of nivolumab in previously treated advanced non–small-cell lung cancer: Results from the CA209-003 study

Scott Gettinger, Leora Horn, David Jackman, David Spigel, Scott Antonia, Matthew Hellmann, John Powderly, Rebecca Heist, Lecia V. Sequist, David C. Smith, Philip Leming, William J. Geese, Dennis Yoon, Ang Li, Julie Brahmer

Research output: Contribution to journalArticlepeer-review

298 Scopus citations


In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non–small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors. Patients and Methods Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method. Results The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had $ 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up. Conclusions Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.

Original languageEnglish (US)
Pages (from-to)1675-1684
Number of pages10
JournalJournal of Clinical Oncology
Issue number17
StatePublished - Jun 10 2018

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


Dive into the research topics of 'Five-year follow-up of nivolumab in previously treated advanced non–small-cell lung cancer: Results from the CA209-003 study'. Together they form a unique fingerprint.

Cite this