First-line nivolumab, paclitaxel, carboplatin, and bevacizumab for advanced non-squamous non-small cell lung cancer : Updated survival analysis of the ONO-4538-52/TASUKI-52 randomized controlled trial
© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd..
BACKGROUND: ONO-4538-52/TASUKI-52 was performed in Japan, Korea, and Taiwan to determine the oncological effectiveness and safety of combining nivolumab or placebo with bevacizumab plus platinum chemotherapy for the initial (first-line) treatment of patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). At the interim analysis (minimum follow-up, 7.4 months), the independent radiology review committee-assessed progression-free survival was significantly longer in the nivolumab arm, but overall survival (OS) data were immature.
METHODS: Here, we present the updated OS data. Patients with treatment-naïve stage IIIB/IV or recurrent nsNSCLC without driver mutations in ALK, EGFR, or ROS1, were randomized 1:1 to receive either nivolumab or placebo. Patients in both arms received paclitaxel, carboplatin, and bevacizumab, administered 3-weekly for a maximum of 6 cycles. Nivolumab/placebo and bevacizumab were subsequently continued until disease progression or unacceptable toxicity.
RESULTS: Overall, 550 patients were randomized. At the time of the analysis (minimum follow-up: 19.4 months), the median OS was longer in the nivolumab arm than in the placebo arm (30.8 vs. 24.7 months; hazard ratio 0.74, 95% confidence interval 0.58-0.94). The 12-month OS rates were 81.3% vs. 76.3% in the nivolumab vs. placebo arms, respectively. The respective 18-month OS rates were 69.0% vs. 61.9%.
CONCLUSION: Nivolumab plus platinum chemotherapy and bevacizumab demonstrated longer OS vs. the placebo combination. We believe this regimen is viable as a standard, first-line treatment for patients with advanced nsNSCLC without driver mutations in ALK, EGFR, or ROS1.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Cancer medicine - 12(2023), 16 vom: 28. Aug., Seite 17061-17067 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kim, Hye Ryun [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 15.09.2023 Date Revised 16.09.2023 published: Print-Electronic ClinicalTrials.gov: NCT03117049 JapicCTI: JapicCTI-173560 Citation Status MEDLINE |
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| doi: |
10.1002/cam4.6348 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Kim, Hye Ryun |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First-line nivolumab, paclitaxel, carboplatin, and bevacizumab for advanced non-squamous non-small cell lung cancer |b Updated survival analysis of the ONO-4538-52/TASUKI-52 randomized controlled trial |
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| 500 | |a Date Completed 15.09.2023 | ||
| 500 | |a Date Revised 16.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03117049 | ||
| 500 | |a JapicCTI: JapicCTI-173560 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: ONO-4538-52/TASUKI-52 was performed in Japan, Korea, and Taiwan to determine the oncological effectiveness and safety of combining nivolumab or placebo with bevacizumab plus platinum chemotherapy for the initial (first-line) treatment of patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). At the interim analysis (minimum follow-up, 7.4 months), the independent radiology review committee-assessed progression-free survival was significantly longer in the nivolumab arm, but overall survival (OS) data were immature | ||
| 520 | |a METHODS: Here, we present the updated OS data. Patients with treatment-naïve stage IIIB/IV or recurrent nsNSCLC without driver mutations in ALK, EGFR, or ROS1, were randomized 1:1 to receive either nivolumab or placebo. Patients in both arms received paclitaxel, carboplatin, and bevacizumab, administered 3-weekly for a maximum of 6 cycles. Nivolumab/placebo and bevacizumab were subsequently continued until disease progression or unacceptable toxicity | ||
| 520 | |a RESULTS: Overall, 550 patients were randomized. At the time of the analysis (minimum follow-up: 19.4 months), the median OS was longer in the nivolumab arm than in the placebo arm (30.8 vs. 24.7 months; hazard ratio 0.74, 95% confidence interval 0.58-0.94). The 12-month OS rates were 81.3% vs. 76.3% in the nivolumab vs. placebo arms, respectively. The respective 18-month OS rates were 69.0% vs. 61.9% | ||
| 520 | |a CONCLUSION: Nivolumab plus platinum chemotherapy and bevacizumab demonstrated longer OS vs. the placebo combination. We believe this regimen is viable as a standard, first-line treatment for patients with advanced nsNSCLC without driver mutations in ALK, EGFR, or ROS1 | ||
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| 700 | 1 | |a Inui, Naoki |e verfasserin |4 aut | |
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| 700 | 1 | |a Tanaka, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Cheng-Ta |e verfasserin |4 aut | |
| 700 | 1 | |a Nishio, Makoto |e verfasserin |4 aut | |
| 700 | 1 | |a Ohe, Yuichiro |e verfasserin |4 aut | |
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| 700 | 1 | |a Nakagawa, Kazuhiko |e verfasserin |4 aut | |
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