Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC : Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial
Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved..
INTRODUCTION: We report the primary analysis from JAVELIN Lung 100, a phase 3 trial comparing avelumab (anti-programmed death-ligand 1 [PD-L1]) versus platinum-based doublet chemotherapy as first-line treatment for PD-L1-positive (+) advanced NSCLC.
METHODS: Adults with PD-L1+ (≥1% of tumor cells; PD-L1 immunohistochemistry 73-10 pharmDx), EGFR and ALK wild-type, previously untreated, stage IV NSCLC were randomized to avelumab 10 mg/kg every 2 weeks (Q2W), avelumab 10 mg/kg once weekly (QW) for 12 weeks and Q2W thereafter, or platinum-based doublet chemotherapy every 3 weeks. Primary end points were overall survival (OS) and progression-free survival (PFS) per independent review committee. The primary analysis population was patients with high-expression PD-L1+ tumors (≥80% of tumor cells).
RESULTS: A total of 1214 patients were randomized to avelumab Q2W (n = 366), avelumab QW (n = 322), or chemotherapy (n = 526). In the primary analysis population, hazard ratios (HRs) for OS and PFS with avelumab Q2W (n = 151) versus chemotherapy (n = 216) were 0.85 (95% confidence interval [CI]: 0.67-1.09; one-sided p = 0.1032; median OS, 20.1 versus 14.9 mo) and 0.71 (95% CI: 0.54-0.93; one-sided p = 0.0070; median PFS, 8.4 versus 5.6 mo), respectively. With avelumab QW (n = 130) versus chemotherapy (n = 129), HRs were 0.79 (95% CI: 0.59-1.07; one-sided p = 0.0630; median OS, 19.3 versus 15.3 mo) and 0.72 (95% CI: 0.52-0.98; one-sided p = 0.0196; median PFS, 7.5 versus 5.6 mo), respectively. No new safety signals were observed.
CONCLUSIONS: Longer median OS and PFS were observed with avelumab versus platinum-based doublet chemotherapy in advanced NSCLC, but differences in OS and PFS were not statistically significant, and the trial did not meet its primary objective.
CLINICALTRIALS: gov Identifier: NCT02576574.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer - 19(2024), 2 vom: 01. Feb., Seite 297-313 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Reck, Martin [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.02.2024 Date Revised 26.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02576574 Citation Status MEDLINE |
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| doi: |
10.1016/j.jtho.2023.09.1445 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362450722 |
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| 100 | 1 | |a Reck, Martin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC |b Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial |
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| 500 | |a Date Revised 26.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02576574 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a INTRODUCTION: We report the primary analysis from JAVELIN Lung 100, a phase 3 trial comparing avelumab (anti-programmed death-ligand 1 [PD-L1]) versus platinum-based doublet chemotherapy as first-line treatment for PD-L1-positive (+) advanced NSCLC | ||
| 520 | |a METHODS: Adults with PD-L1+ (≥1% of tumor cells; PD-L1 immunohistochemistry 73-10 pharmDx), EGFR and ALK wild-type, previously untreated, stage IV NSCLC were randomized to avelumab 10 mg/kg every 2 weeks (Q2W), avelumab 10 mg/kg once weekly (QW) for 12 weeks and Q2W thereafter, or platinum-based doublet chemotherapy every 3 weeks. Primary end points were overall survival (OS) and progression-free survival (PFS) per independent review committee. The primary analysis population was patients with high-expression PD-L1+ tumors (≥80% of tumor cells) | ||
| 520 | |a RESULTS: A total of 1214 patients were randomized to avelumab Q2W (n = 366), avelumab QW (n = 322), or chemotherapy (n = 526). In the primary analysis population, hazard ratios (HRs) for OS and PFS with avelumab Q2W (n = 151) versus chemotherapy (n = 216) were 0.85 (95% confidence interval [CI]: 0.67-1.09; one-sided p = 0.1032; median OS, 20.1 versus 14.9 mo) and 0.71 (95% CI: 0.54-0.93; one-sided p = 0.0070; median PFS, 8.4 versus 5.6 mo), respectively. With avelumab QW (n = 130) versus chemotherapy (n = 129), HRs were 0.79 (95% CI: 0.59-1.07; one-sided p = 0.0630; median OS, 19.3 versus 15.3 mo) and 0.72 (95% CI: 0.52-0.98; one-sided p = 0.0196; median PFS, 7.5 versus 5.6 mo), respectively. No new safety signals were observed | ||
| 520 | |a CONCLUSIONS: Longer median OS and PFS were observed with avelumab versus platinum-based doublet chemotherapy in advanced NSCLC, but differences in OS and PFS were not statistically significant, and the trial did not meet its primary objective | ||
| 520 | |a CLINICALTRIALS: gov Identifier: NCT02576574 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Avelumab | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a First-line | |
| 650 | 4 | |a Non–small cell lung cancer | |
| 650 | 4 | |a Phase 3 | |
| 650 | 7 | |a Antibodies, Monoclonal |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a avelumab |2 NLM | |
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| 700 | 1 | |a Barlesi, Fabrice |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, James Chih-Hsin |e verfasserin |4 aut | |
| 700 | 1 | |a Westeel, Virginie |e verfasserin |4 aut | |
| 700 | 1 | |a Felip, Enriqueta |e verfasserin |4 aut | |
| 700 | 1 | |a Özgüroğlu, Mustafa |e verfasserin |4 aut | |
| 700 | 1 | |a Dols, Manuel Cobo |e verfasserin |4 aut | |
| 700 | 1 | |a Sullivan, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Kowalski, Dariusz M |e verfasserin |4 aut | |
| 700 | 1 | |a Andric, Zoran |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Dae Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Sezer, Ahmet |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, XiaoZhe |e verfasserin |4 aut | |
| 700 | 1 | |a von Heydebreck, Anja |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob, Natalia |e verfasserin |4 aut | |
| 700 | 1 | |a Mehr, Keyvan Tadjalli |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Keunchil |e verfasserin |4 aut | |
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