First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial

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dc.contributor.authorJanjigian, Yelena Y.
dc.contributor.authorAjani, Jaffer A.
dc.contributor.authorMoehler, Markus
dc.contributor.authorShen, Lin
dc.contributor.authorGarrido, Marcelo
dc.contributor.authorGallardo, Carlos
dc.contributor.authorWyrwicz, Lucjan
dc.contributor.authorYamaguchi, Kensei
dc.contributor.authorCleary, James M.
dc.contributor.authorElimova, Elena
dc.contributor.authorKaramouzis, Michalis
dc.contributor.authorBruges, Ricardo
dc.contributor.authorSkoczylas, Tomasz
dc.contributor.authorBragagnoli, Arinilda
dc.contributor.authorLiu, Tianshi
dc.contributor.authorTehfe, Mustapha
dc.contributor.authorZander, Thomas
dc.contributor.authorKowalyszyn, Ruben
dc.contributor.authorPazo-Cid, Roberto
dc.contributor.authorSchenker, Michael
dc.contributor.authorFeeny, Kynan
dc.contributor.authorWang, Rui
dc.contributor.authorLei, Ming
dc.contributor.authorChen, Clara
dc.contributor.authorNathani, Raheel
dc.contributor.authorShitara, Kohei
dc.date.accessioned2025-01-20T16:13:43Z
dc.date.available2025-01-20T16:13:43Z
dc.date.issued2024
dc.description.abstractClinical 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.
dc.fuente.origenWOS
dc.identifier.doi10.1200/JCO.23.01601
dc.identifier.eissn1527-7755
dc.identifier.issn0732-183X
dc.identifier.urihttps://doi.org/10.1200/JCO.23.01601
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/90402
dc.identifier.wosidWOS:001244487700005
dc.issue.numero17
dc.language.isoen
dc.revistaJournal of clinical oncology
dc.rightsacceso restringido
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleFirst-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial
dc.typeartículo
dc.volumen42
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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