First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma : 3-Year Follow-Up of the Phase III CheckMate 649 Trial
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 3-year efficacy and safety results from the phase III CheckMate 649 trial. Patients with previously untreated advanced or metastatic gastroesophageal adenocarcinoma were randomly assigned to nivolumab plus chemotherapy or chemotherapy. Primary end points were overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors expressed PD-L1 combined positive score (CPS) ≥5. With 36.2-month minimum follow-up, for patients with PD-L1 CPS ≥5, the OS hazard ratio (HR) for nivolumab plus chemotherapy versus chemotherapy was 0.70 (95% CI, 0.61 to 0.81); 21% versus 10% of patients were alive at 36 months, respectively; the PFS HR was 0.70 (95% CI, 0.60 to 0.81); 36-month PFS rates were 13% versus 8%, respectively. The objective response rate (ORR) per BICR was 60% (95% CI, 55 to 65) with nivolumab plus chemotherapy versus 45% (95% CI, 40 to 50) with chemotherapy; median duration of response was 9.6 months (95% CI, 8.2 to 12.4) versus 7.0 months (95% CI, 5.6 to 7.9), respectively. Nivolumab plus chemotherapy also continued to show improvement in OS, PFS, and ORR versus chemotherapy in the overall population. Adding nivolumab to chemotherapy maintained clinically meaningful long-term survival benefit versus chemotherapy alone, with an acceptable safety profile, supporting the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastroesophageal adenocarcinoma.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - (2024) vom: 21. Feb., Seite JCO2301601 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Janjigian, Yelena Y [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 21.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02872116 Citation Status Publisher |
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| doi: |
10.1200/JCO.23.01601 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368720276 |
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| 100 | 1 | |a Janjigian, Yelena Y |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma |b 3-Year Follow-Up of the Phase III CheckMate 649 Trial |
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| 500 | |a Date Revised 21.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02872116 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a 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 3-year efficacy and safety results from the phase III CheckMate 649 trial. Patients with previously untreated advanced or metastatic gastroesophageal adenocarcinoma were randomly assigned to nivolumab plus chemotherapy or chemotherapy. Primary end points were overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors expressed PD-L1 combined positive score (CPS) ≥5. With 36.2-month minimum follow-up, for patients with PD-L1 CPS ≥5, the OS hazard ratio (HR) for nivolumab plus chemotherapy versus chemotherapy was 0.70 (95% CI, 0.61 to 0.81); 21% versus 10% of patients were alive at 36 months, respectively; the PFS HR was 0.70 (95% CI, 0.60 to 0.81); 36-month PFS rates were 13% versus 8%, respectively. The objective response rate (ORR) per BICR was 60% (95% CI, 55 to 65) with nivolumab plus chemotherapy versus 45% (95% CI, 40 to 50) with chemotherapy; median duration of response was 9.6 months (95% CI, 8.2 to 12.4) versus 7.0 months (95% CI, 5.6 to 7.9), respectively. Nivolumab plus chemotherapy also continued to show improvement in OS, PFS, and ORR versus chemotherapy in the overall population. Adding nivolumab to chemotherapy maintained clinically meaningful long-term survival benefit versus chemotherapy alone, with an acceptable safety profile, supporting the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastroesophageal adenocarcinoma | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Ajani, Jaffer A |e verfasserin |4 aut | |
| 700 | 1 | |a Moehler, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Garrido, Marcelo |e verfasserin |4 aut | |
| 700 | 1 | |a Gallardo, Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Wyrwicz, Lucjan |e verfasserin |4 aut | |
| 700 | 1 | |a Yamaguchi, Kensei |e verfasserin |4 aut | |
| 700 | 1 | |a Cleary, James M |e verfasserin |4 aut | |
| 700 | 1 | |a Elimova, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Karamouzis, Michalis |e verfasserin |4 aut | |
| 700 | 1 | |a Bruges, Ricardo |e verfasserin |4 aut | |
| 700 | 1 | |a Skoczylas, Tomasz |e verfasserin |4 aut | |
| 700 | 1 | |a Bragagnoli, Arinilda |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Tianshi |e verfasserin |4 aut | |
| 700 | 1 | |a Tehfe, Mustapha |e verfasserin |4 aut | |
| 700 | 1 | |a Zander, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Kowalyszyn, Ruben |e verfasserin |4 aut | |
| 700 | 1 | |a Pazo-Cid, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Schenker, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Feeny, Kynan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Rui |e verfasserin |4 aut | |
| 700 | 1 | |a Lei, Ming |e verfasserin |4 aut | |
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| 700 | 1 | |a Nathani, Raheel |e verfasserin |4 aut | |
| 700 | 1 | |a Shitara, Kohei |e verfasserin |4 aut | |
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