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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

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Gettinger, Scott N., Horn, Leora, Gandhi, Leena, Spigel, David R., Antonia, Scott J., Rizvi, Naiyer A., Powderly, John D., Heist, Rebecca S., Carvajal, Richard D., Jackman, David M., Sequist, Lecia V., Smith, David C., Leming, Philip, Carbone, David P., Pinder-Schenck, Mary C., Topalian, Suzanne L., Hodi, F. Stephen, Sosman, Jeffrey A., Sznol, Mario, McDermott, David F., Pardoll, Drew M., Sankar, Vindira, Ahlers, Christoph M., Salvati, Mark, Wigginton, Jon M., Hellmann, Matthew D., Kollia, Georgia D., Gupta, Ashok K., Brahmer, Julie R.·2015·Journal of Clinical Oncology

DOI 10.1200/jco.2014.58.3708

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Abstract

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.

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Rice, S. J., Liu, X., Zhang, J., & Belani, C. P. (2019) · PROTEOMICS · doi:10.1002/pmic.201800135 · Cited by 12
Clinical and Biological Activity of Chemoimmunotherapy in Advanced Endometrial Adenocarcinoma: A Phase II Trial of the Big Ten Cancer Research Consortium
Barber, E. L., Chen, S., Pineda, M. J., Robertson, S. E., Hill, E. K., Teoh, D., Schilder, J., O'Shea, K. L., Kocherginsky, M., Zhang, B., et al. (2022) · Cancer Research Communications · doi:10.1158/2767-9764.crc-22-0147 · Cited by 9

Authors: Gettinger, S. N., Horn, L., Gandhi, L., Spigel, D. R., Antonia, S. J., Rizvi, N. A., Powderly, J. D., Heist, R. S., Carvajal, R. D., Jackman, D. M., Sequist, L. V., Smith, D. C., Leming, P., Carbone, D. P., Pinder-Schenck, M. C., Topalian, S. L., Hodi, F. S., Sosman, J. A., Sznol, M., McDermott, D. F., Pardoll, D. M., Sankar, V., Ahlers, C. M., Salvati, M., Wigginton, J. M., Hellmann, M. D., Kollia, G. D., Gupta, A. K., & Brahmer, J. R.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2015-06-20
Volume: 33
Issue: 18
Pages: 2004-2012
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2014.58.3708
OpenAlex: W2143488876
Cited by: 1,177
References: 10
FWCI: 77.75
Type: journal article
Language: en
Open access: bronze

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.

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

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