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Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10082300/ https://www.ncbi.nlm.nih.gov/pubmed/36735893 http://dx.doi.org/10.1200/JCO.22.01990 |
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author | Novello, Silvia Kowalski, Dariusz M. Luft, Alexander Gümüş, Mahmut Vicente, David Mazières, Julien Rodríguez-Cid, Jeronimo Tafreshi, Ali Cheng, Ying Lee, Ki Hyeong Golf, Alexander Sugawara, Shunichi Robinson, Andrew G. Halmos, Balazs Jensen, Erin Schwarzenberger, Paul Pietanza, M. Catherine Paz-Ares, Luis |
author_facet | Novello, Silvia Kowalski, Dariusz M. Luft, Alexander Gümüş, Mahmut Vicente, David Mazières, Julien Rodríguez-Cid, Jeronimo Tafreshi, Ali Cheng, Ying Lee, Ki Hyeong Golf, Alexander Sugawara, Shunichi Robinson, Andrew G. Halmos, Balazs Jensen, Erin Schwarzenberger, Paul Pietanza, M. Catherine Paz-Ares, Luis |
author_sort | Novello, Silvia |
collection | PubMed |
description | Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We report 5-year efficacy and safety outcomes from the phase III KEYNOTE-407 study (ClinicalTrials.gov identifier: NCT02775435). Eligible patients with previously untreated, metastatic squamous non–small-cell lung cancer (NSCLC) were randomly assigned 1:1 to pembrolizumab 200 mg or placebo plus carboplatin and paclitaxel/nab-paclitaxel once every 3 weeks for four cycles, followed by pembrolizumab or placebo for up to 35 cycles. Primary end points were overall survival (OS) and progression-free survival (PFS) per RECIST version 1.1 by blinded independent central review (BICR). Five hundred fifty-nine patients were randomly assigned in the intention-to-treat population (pembrolizumab plus chemotherapy, n = 278; placebo plus chemotherapy, n = 281). The median time from random assignment to data cutoff was 56.9 (range, 49.9-66.2) months. OS and PFS were improved with pembrolizumab plus chemotherapy versus placebo plus chemotherapy (hazard ratio [95% CI], 0.71 [0.59 to 0.85] and 0.62 [0.52 to 0.74]), with 5-year OS rates of 18.4% versus 9.7%, respectively. Toxicity was manageable. Among 55 patients who completed 35 cycles of pembrolizumab, the objective response rate was 90.9% and the 3-year OS rate after completion of 35 cycles (approximately 5 years after random assignment) was 69.5%. Pembrolizumab plus chemotherapy maintained an OS and PFS benefit versus placebo plus chemotherapy in previously untreated, metastatic squamous NSCLC and is a standard-of-care first-line treatment option for metastatic squamous NSCLC regardless of programmed death ligand 1 expression. |
format | Online Article Text |
id | pubmed-10082300 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-100823002023-04-09 Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study Novello, Silvia Kowalski, Dariusz M. Luft, Alexander Gümüş, Mahmut Vicente, David Mazières, Julien Rodríguez-Cid, Jeronimo Tafreshi, Ali Cheng, Ying Lee, Ki Hyeong Golf, Alexander Sugawara, Shunichi Robinson, Andrew G. Halmos, Balazs Jensen, Erin Schwarzenberger, Paul Pietanza, M. Catherine Paz-Ares, Luis J Clin Oncol CLINICAL TRIAL UPDATES Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We report 5-year efficacy and safety outcomes from the phase III KEYNOTE-407 study (ClinicalTrials.gov identifier: NCT02775435). Eligible patients with previously untreated, metastatic squamous non–small-cell lung cancer (NSCLC) were randomly assigned 1:1 to pembrolizumab 200 mg or placebo plus carboplatin and paclitaxel/nab-paclitaxel once every 3 weeks for four cycles, followed by pembrolizumab or placebo for up to 35 cycles. Primary end points were overall survival (OS) and progression-free survival (PFS) per RECIST version 1.1 by blinded independent central review (BICR). Five hundred fifty-nine patients were randomly assigned in the intention-to-treat population (pembrolizumab plus chemotherapy, n = 278; placebo plus chemotherapy, n = 281). The median time from random assignment to data cutoff was 56.9 (range, 49.9-66.2) months. OS and PFS were improved with pembrolizumab plus chemotherapy versus placebo plus chemotherapy (hazard ratio [95% CI], 0.71 [0.59 to 0.85] and 0.62 [0.52 to 0.74]), with 5-year OS rates of 18.4% versus 9.7%, respectively. Toxicity was manageable. Among 55 patients who completed 35 cycles of pembrolizumab, the objective response rate was 90.9% and the 3-year OS rate after completion of 35 cycles (approximately 5 years after random assignment) was 69.5%. Pembrolizumab plus chemotherapy maintained an OS and PFS benefit versus placebo plus chemotherapy in previously untreated, metastatic squamous NSCLC and is a standard-of-care first-line treatment option for metastatic squamous NSCLC regardless of programmed death ligand 1 expression. Wolters Kluwer Health 2023-04-10 2023-02-03 /pmc/articles/PMC10082300/ /pubmed/36735893 http://dx.doi.org/10.1200/JCO.22.01990 Text en © 2023 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
spellingShingle | CLINICAL TRIAL UPDATES Novello, Silvia Kowalski, Dariusz M. Luft, Alexander Gümüş, Mahmut Vicente, David Mazières, Julien Rodríguez-Cid, Jeronimo Tafreshi, Ali Cheng, Ying Lee, Ki Hyeong Golf, Alexander Sugawara, Shunichi Robinson, Andrew G. Halmos, Balazs Jensen, Erin Schwarzenberger, Paul Pietanza, M. Catherine Paz-Ares, Luis Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title | Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title_full | Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title_fullStr | Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title_full_unstemmed | Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title_short | Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study |
title_sort | pembrolizumab plus chemotherapy in squamous non–small-cell lung cancer: 5-year update of the phase iii keynote-407 study |
topic | CLINICAL TRIAL UPDATES |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10082300/ https://www.ncbi.nlm.nih.gov/pubmed/36735893 http://dx.doi.org/10.1200/JCO.22.01990 |
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