Journal article 16 views
Long-term outcomes among patients who respond within the first year to nivolumab plus ipilimumab or nivolumab monotherapy: A pooled analysis in 935 patients
C Robert,
G V Long,
J Larkin,
J D Wolchok,
J C Hassel,
D Schadendorf,
F S Hodi,
C Lebbé,
J-J Grob,
J R Hyngstrom,
John Wagstaff,
J Chesney,
M O Butler,
O Bechter,
I Márquez-Rodas,
A C Pavlick,
P Durani,
M Pe Benito,
P Wang,
M A Postow,
P A Ascierto
European Journal of Cancer, Volume: 214, Start page: 115119
Swansea University Author: John Wagstaff
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DOI (Published version): 10.1016/j.ejca.2024.115119
Abstract
Purpose: To investigate the predictive value of RECIST response within 3, 6, or 12 months on long-term survival, and explore differences between nivolumab+ipilimumab and nivolumab monotherapy, we analyzed pooled 5-year data of 935 responder and non-responder patients at various time points after tre...
| Published in: | European Journal of Cancer |
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| ISSN: | 0959-8049 1879-0852 |
| Published: |
Elsevier BV
2025
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa68590 |
| Abstract: |
Purpose: To investigate the predictive value of RECIST response within 3, 6, or 12 months on long-term survival, and explore differences between nivolumab+ipilimumab and nivolumab monotherapy, we analyzed pooled 5-year data of 935 responder and non-responder patients at various time points after treatment initiation in CheckMate 069, 066, and 067 studies. Patients and methods: Treatment-naive advanced melanoma patients received nivolumab+ipilimumab or nivolumab monotherapy. To decrease immortal time bias, 3-, 6-, or 12-month overall survival (OS) and progression-free survival (PFS) landmark analyses were performed. Association between characteristics and response was evaluated by univariate and multivariate analyses. Results: Response rates at any time were 58 % (239/409) for nivolumab+ipilimumab and 44 % (230/526) for nivolumab monotherapy. In 12-month landmark analyses, 5-year OS rates for responders versus non-responders were 82 % versus 40 % with nivolumab+ipilimumab (HR=0.23 [95 % CI, 0.15-0.35]) and 76 % versus 32 % with nivolumab monotherapy (HR=0.22 [95 % CI, 0.16-0.31]). PFS rates were 83 % versus 32 % and 69 % versus 46 %, respectively. Similar strong associations between response at 3 and 6 months and 5-year OS and PFS were also observed with more than 70 % of the responses observed in the first 3 months. Response rates correlated with baseline LDH and PD-L1 status by multivariate analysis but the association between response and long-term survival was maintained in landmark analyses even among patients with high LDH and low PD-L1 expression. Conclusion: Clinical response evaluated in the first months of therapy is a strong predictor of long-term survival, even in patients with poor prognostic biomarkers. |
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| Keywords: |
Clinical response; Long-term survival; Advanced melanoma; Nivolumab; Ipilimumab; Prognostic factors |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
The authors thank the patients and investigators who participated in the CheckMate 069, 066 and 067 trials. They acknowledge Ono Pharmaceutical Company, Ltd. (Osaka, Japan) for contributions to nivolumab development and Dako, an Agilent Technologies, Inc. company (Santa Clara, CA) for collaborative development of the PD-L1 immunohistochemistry 28–8 pharmDx assay. The authors thank Wim van Dijck from Bristol Myers Squibb for statistical contributions for the study, as well as Sandra Re and Jasmine Rizzo from Bristol Myers Squibb for medical oversight. Professional medical writing and editorial assistance were provided by Melissa Kirk, PhD, and Michele Salernitano at Ashfield MedComms, an Inizio Company, funded by Bristol Myers Squibb. M. Postow acknowledges support from the NIH/NCI Cancer Center Support Grant P30 CA008748. J. Wagstaff acknowledges grant support MSK P30 CA008748. J. Larkin acknowledges grant support from the National Institute for Health Research Royal Marsden-Institute of Cancer Research Biomedical Research Centre.
This work was supported by Bristol Myers Squibb (Princeton, NJ). |
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