Overall Survival and Long-Term Safety of Nivolumab (Anti–Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer
| Autor: | Naiyer A. Rizvi, David Smith, Jon M. Wigginton, David F. McDermott, Scott J. Antonia, David M. Jackman, Mario Sznol, Leena Gandhi, Richard D. Carvajal, Ashok Kumar Gupta, David R. Spigel, John D. Powderly, Rebecca S. Heist, Scott N. Gettinger, Mark E. Salvati, Lecia V. Sequist, Julie R. Brahmer, Matthew D. Hellmann, Mary Pinder-Schenck, Georgia Kollia, Christoph Matthias Ahlers, David P. Carbone, Suzanne L. Topalian, Philip D. Leming, Jeffrey A. Sosman, Drew M. Pardoll, Leora Horn, F. Stephen Hodi, Vindira Sankar |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Lung Neoplasms Antineoplastic Agents Carcinoma Non-Small-Cell Lung Internal medicine Carcinoma Humans Medicine In patient Lung cancer Carcinoma Renal Cell biology business.industry Antibodies Monoclonal ORIGINAL REPORTS medicine.disease Kidney Neoplasms Immune checkpoint Clinical trial Immunology biology.protein Female Programmed death 1 Nivolumab Antibody business |
| Zdroj: | Journal of Clinical Oncology. 33:2004-2012 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2014.58.3708 |
| Popis: | Purpose Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed death 1 immune checkpoint inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated in a phase I trial with expansion cohorts. We report overall survival (OS), response durability, and long-term safety in patients with non–small-cell lung cancer (NSCLC) receiving nivolumab in this trial. Patients and Methods Patients (N = 129) with heavily pretreated advanced NSCLC received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. Tumor burden was assessed by RECIST (version 1.0) after each cycle. Results Median OS across doses was 9.9 months; 1-, 2-, and 3-year OS rates were 42%, 24%, and 18%, respectively, across doses and 56%, 42%, and 27%, respectively, at the 3-mg/kg dose (n = 37) chosen for further clinical development. Among 22 patients (17%) with objective responses, estimated median response duration was 17.0 months. An additional six patients (5%) had unconventional immune-pattern responses. Response rates were similar in squamous and nonsquamous NSCLC. Eighteen responding patients discontinued nivolumab for reasons other than progressive disease; nine (50%) of those had responses lasting > 9 months after their last dose. Grade 3 to 4 treatment-related adverse events occurred in 14% of patients. Three treatment-related deaths (2% of patients) occurred, each associated with pneumonitis. Conclusion Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated NSCLC. Randomized clinical trials with nivolumab in advanced NSCLC are ongoing. |
| Databáze: | OpenAIRE |
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