Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non–Small-Cell Lung Cancer: The Phase III POSEIDON Study
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- Melissa L. Johnson
- Sarah Cannon Research Institute, Tennessee Oncology, PLLC, Nashville, TN
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- Byoung Chul Cho
- Yonsei Cancer Center, Seoul, South Korea
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- Alexander Luft
- Leningrad Regional Clinical Hospital, St Petersburg, Russia
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- Jorge Alatorre-Alexander
- Health Pharma Professional Research, Mexico City, Mexico
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- Sarayut Lucien Geater
- Prince of Songkla University, Songkhla, Thailand
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- Konstantin Laktionov
- Federal State Budgetary Institution “N.N. Blokhin National Medical Research Center of Oncology” of the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia
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- Sang-We Kim
- Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
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- Grygorii Ursol
- Acinus, Kropyvnytskyi, Ukraine
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- Maen Hussein
- Florida Cancer Specialists—Sarah Cannon Research Institute, Leesburg, FL
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- Farah Louise Lim
- Queen Mary University of London, London, United Kingdom
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- Cheng-Ta Yang
- Chang Gung Memorial Hospital, Taoyuan City, Taiwan
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- Luiz Henrique Araujo
- Instituto Nacional de Cancer-INCA, Rio de Janeiro, Brazil
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- Haruhiro Saito
- Kanagawa Cancer Center, Yokohama, Japan
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- Niels Reinmuth
- Asklepios Lung Clinic, member of the German Center for Lung Research (DZL), Munich-Gauting, Germany
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- Xiaojin Shi
- AstraZeneca, Gaithersburg, MD
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- Lynne Poole
- AstraZeneca, Cambridge, United Kingdom
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- Solange Peters
- Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland
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- Edward B. Garon
- David Geffen School of Medicine at UCLA, Los Angeles, CA
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- Tony Mok
- State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China
説明
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> The open-label, phase III POSEIDON study evaluated tremelimumab plus durvalumab and chemotherapy (T + D + CT) and durvalumab plus chemotherapy (D + CT) versus chemotherapy alone (CT) in first-line metastatic non–small-cell lung cancer (mNSCLC). </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Patients (n = 1,013) with EGFR/ ALK wild-type mNSCLC were randomly assigned (1:1:1) to tremelimumab 75 mg plus durvalumab 1,500 mg and platinum-based chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression and one additional tremelimumab dose; durvalumab plus chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression; or chemotherapy for up to six 21-day cycles (with or without maintenance pemetrexed; all arms). Primary end points were progression-free survival (PFS) and overall survival (OS) for D + CT versus CT. Key alpha-controlled secondary end points were PFS and OS for T + D + CT versus CT. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> PFS was significantly improved with D + CT versus CT (hazard ratio [HR], 0.74; 95% CI, 0.62 to 0.89; P = .0009; median, 5.5 v 4.8 months); a trend for improved OS did not reach statistical significance (HR, 0.86; 95% CI, 0.72 to 1.02; P = .0758; median, 13.3 v 11.7 months; 24-month OS, 29.6% v 22.1%). PFS (HR, 0.72; 95% CI, 0.60 to 0.86; P = .0003; median, 6.2 v 4.8 months) and OS (HR, 0.77; 95% CI, 0.65 to 0.92; P = .0030; median, 14.0 v 11.7 months; 24-month OS, 32.9% v 22.1%) were significantly improved with T + D + CT versus CT. Treatment-related adverse events were maximum grade 3/4 in 51.8%, 44.6%, and 44.4% of patients receiving T + D + CT, D + CT, and CT, respectively; 15.5%, 14.1%, and 9.9%, respectively, discontinued treatment because of treatment-related adverse events. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> D + CT significantly improved PFS versus CT. A limited course of tremelimumab added to durvalumab and chemotherapy significantly improved OS and PFS versus CT, without meaningful additional tolerability burden, representing a potential new option in first-line mNSCLC. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 41 (6), 1213-1227, 2023-02-20
American Society of Clinical Oncology (ASCO)