Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis

Background: Tebentafusp demonstrated a superior overall survival (OS) benefit [hazard ratio (HR) 0.51] compared to investigator’s choice (82% pembrolizumab) in a randomized, phase III trial (IMCgp100-202; N ¼ 378) in untreated metastatic uveal melanoma (mUM). The 1-year OS rates for tebentafusp and...

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Autores: Piulats, J. M., Watkins, C., Costa García, M., del Carpio, L., Piperno-Neumann, S., Rutkowski, P., Cruz Merino, Luis de la, Nathan, P.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/155708
Acceso en línea:https://hdl.handle.net/11441/155708
https://doi.org/10.1016/j.annonc.2023.11.013
Access Level:acceso abierto
Palabra clave:Ipilimumab
Metastatic uveal melanoma
Nivolumab
Overall survival
Propensity score-weighted analysis
Tebentafusp
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spelling Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysisPiulats, J. M.Watkins, C.Costa García, M.del Carpio, L.Piperno-Neumann, S.Rutkowski, P.Cruz Merino, Luis de laNathan, P.IpilimumabMetastatic uveal melanomaNivolumabOverall survivalPropensity score-weighted analysisTebentafuspBackground: Tebentafusp demonstrated a superior overall survival (OS) benefit [hazard ratio (HR) 0.51] compared to investigator’s choice (82% pembrolizumab) in a randomized, phase III trial (IMCgp100-202; N ¼ 378) in untreated metastatic uveal melanoma (mUM). The 1-year OS rates for tebentafusp and pembrolizumab were 73% and 59%, respectively. In the single-arm GEM1402 (N ¼ 52), the 1-year OS rate for nivolumab plus ipilimumab (NþI) in mUM was 52%. Due to limitations in conducting randomized trials in mUM, we compared OS on tebentafusp or pembrolizumab (IMCgp100-202) to NþI (GEM1402) in untreated mUM using propensity scoring methods. Patients and methods: Analyses were adjusted using propensity score-based inverse probability of treatment weighting (IPTW), balancing age, sex, baseline lactate dehydrogenase (LDH), baseline alkaline phosphatase, disease location, Eastern Cooperative Oncology Group status, and time from primary diagnosis to metastasis. OS was assessed using IPT-weighted KaplaneMeier and Cox proportional hazard models. Sensitivity analyses using alternative missing data and weights methods were conducted. Results: The primary IPTW analysis included 240 of 252 patients randomized to tebentafusp from IMCgp100-202 and 45 of 52 NþI-treated patients from GEM-1402. Key baseline covariates, including LDH, were generally well balanced before weighting. The IPTW-adjusted OS favored tebentafusp, HR 0.52 [95% confidence interval (CI) 0.35-0.78]; 1-year OS was 73% for tebentafusp versus 50% for NþI. Sensitivity analyses showed consistent superior OS for tebentafusp with all IPTW HRs 0.61. IPTW analysis of pembrolizumab versus NþI showed no significant difference in OS (HR 0.72; 95% CI 0.50-1.06). Conclusions: Tebentafusp was previously shown to provide an OS benefit compared to checkpoint inhibitors or chemotherapy in untreated mUM. Propensity score analysis demonstrated a similar OS benefit for tebentafusp compared with NþI. These data further support tebentafusp as the standard of care in previously untreated human leukocyte antigen (HLA)-A*02:01þ adult patients with mUM.Oxford University PressMedicinaCTS151: Bioquímica médica2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/155708https://doi.org/10.1016/j.annonc.2023.11.013reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésAnnals of oncology, 35 (3), 317-326.https://www.sciencedirect.com/science/article/pii/S0923753423051001?via%3Dihubinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1557082026-06-17T12:51:07Z
dc.title.none.fl_str_mv Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
title Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
spellingShingle Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
Piulats, J. M.
Ipilimumab
Metastatic uveal melanoma
Nivolumab
Overall survival
Propensity score-weighted analysis
Tebentafusp
title_short Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
title_full Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
title_fullStr Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
title_full_unstemmed Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
title_sort Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line metastatic uveal melanoma: a propensity score-weighted analysis
dc.creator.none.fl_str_mv Piulats, J. M.
Watkins, C.
Costa García, M.
del Carpio, L.
Piperno-Neumann, S.
Rutkowski, P.
Cruz Merino, Luis de la
Nathan, P.
author Piulats, J. M.
author_facet Piulats, J. M.
Watkins, C.
Costa García, M.
del Carpio, L.
Piperno-Neumann, S.
Rutkowski, P.
Cruz Merino, Luis de la
Nathan, P.
author_role author
author2 Watkins, C.
Costa García, M.
del Carpio, L.
Piperno-Neumann, S.
Rutkowski, P.
Cruz Merino, Luis de la
Nathan, P.
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
CTS151: Bioquímica médica
dc.subject.none.fl_str_mv Ipilimumab
Metastatic uveal melanoma
Nivolumab
Overall survival
Propensity score-weighted analysis
Tebentafusp
topic Ipilimumab
Metastatic uveal melanoma
Nivolumab
Overall survival
Propensity score-weighted analysis
Tebentafusp
description Background: Tebentafusp demonstrated a superior overall survival (OS) benefit [hazard ratio (HR) 0.51] compared to investigator’s choice (82% pembrolizumab) in a randomized, phase III trial (IMCgp100-202; N ¼ 378) in untreated metastatic uveal melanoma (mUM). The 1-year OS rates for tebentafusp and pembrolizumab were 73% and 59%, respectively. In the single-arm GEM1402 (N ¼ 52), the 1-year OS rate for nivolumab plus ipilimumab (NþI) in mUM was 52%. Due to limitations in conducting randomized trials in mUM, we compared OS on tebentafusp or pembrolizumab (IMCgp100-202) to NþI (GEM1402) in untreated mUM using propensity scoring methods. Patients and methods: Analyses were adjusted using propensity score-based inverse probability of treatment weighting (IPTW), balancing age, sex, baseline lactate dehydrogenase (LDH), baseline alkaline phosphatase, disease location, Eastern Cooperative Oncology Group status, and time from primary diagnosis to metastasis. OS was assessed using IPT-weighted KaplaneMeier and Cox proportional hazard models. Sensitivity analyses using alternative missing data and weights methods were conducted. Results: The primary IPTW analysis included 240 of 252 patients randomized to tebentafusp from IMCgp100-202 and 45 of 52 NþI-treated patients from GEM-1402. Key baseline covariates, including LDH, were generally well balanced before weighting. The IPTW-adjusted OS favored tebentafusp, HR 0.52 [95% confidence interval (CI) 0.35-0.78]; 1-year OS was 73% for tebentafusp versus 50% for NþI. Sensitivity analyses showed consistent superior OS for tebentafusp with all IPTW HRs 0.61. IPTW analysis of pembrolizumab versus NþI showed no significant difference in OS (HR 0.72; 95% CI 0.50-1.06). Conclusions: Tebentafusp was previously shown to provide an OS benefit compared to checkpoint inhibitors or chemotherapy in untreated mUM. Propensity score analysis demonstrated a similar OS benefit for tebentafusp compared with NþI. These data further support tebentafusp as the standard of care in previously untreated human leukocyte antigen (HLA)-A*02:01þ adult patients with mUM.
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/155708
https://doi.org/10.1016/j.annonc.2023.11.013
url https://hdl.handle.net/11441/155708
https://doi.org/10.1016/j.annonc.2023.11.013
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Annals of oncology, 35 (3), 317-326.
https://www.sciencedirect.com/science/article/pii/S0923753423051001?via%3Dihub
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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