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J Clin Oncol. 2018 Jun 10;36(17):1675-1684. doi: 10.1200/JCO.2017.77.0412. Epub 2018 Mar 23.

Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study.

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Scott Gettinger, Yale Cancer Center, New Haven, CT; Leora Horn, Vanderbilt University Medical Center; David Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; David Jackman, Dana-Farber Cancer Institute; Rebecca Heist and Lecia V. Sequist, Massachusetts General Hospital, Boston, MA; Scott Antonia, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Matthew Hellmann, Memorial Sloan-Kettering Cancer Center, New York, NY; John Powderly, Carolina BioOncology Institute, Huntersville, NC; David C. Smith, University of Michigan, Ann Arbor, MI; Philip Leming, The Christ Hospital Cancer Center, Cincinnati, OH; William J. Geese, Dennis Yoon, and Ang Li, Bristol-Myers Squibb, Princeton, NJ; Julie Brahmer, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.


Purpose 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.

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