TY - JOUR
T1 - Efficacy of First-Line Nivolumab Plus Ipilimumab in Unresectable Pleural Mesothelioma
T2 - A Multicenter Real-World Study (ImmunoMeso LATAM)
AU - Enrico, Diego
AU - Gomez, Juan Elias
AU - Aguirre, Danilo
AU - Tissera, Natalia Soledad
AU - Tsou, Florencia
AU - Pupareli, Carmen
AU - Tanco, Delfina Peralta
AU - Waisberg, Federico
AU - Rodríguez, Andrés
AU - Rizzo, Manglio
AU - Minatta, Nicolás
AU - Rafael, Picon
AU - Basbus, Luis
AU - Lupinacci, Lorena
AU - Kaen, Diego
AU - Ramos, Mauro
AU - Bluthgen, Virginia
AU - Castagneris, Nicolas
AU - Coppola, María Pía
AU - Scocimarro, Alejandra
AU - Guerra, María Florencia
AU - Perfetti, Aldo
AU - Levit, Patricio
AU - Galvez-Nino, Marco
AU - Mas, Luis
AU - Rojas, Leonardo
AU - Zuluaga, Jairo
AU - Chacón, Matías
AU - Corrales, Luis
AU - Samtani, Suraj
AU - Arrieta, Oscar
AU - Cardona, Andrés
AU - Remon, Jordi
AU - Martín, Claudio
N1 - Publisher Copyright:
© 2024 Elsevier Inc.
PY - 2024/12/1
Y1 - 2024/12/1
N2 - Background: The phase 3 CheckMate-743 trial demonstrated a prolonged overall survival (OS) benefit with nivolumab plus ipilimumab over chemotherapy as first-line treatment in patients with unresectable pleural mesothelioma (PM). However, given that Latin American (LATAM) patients were notably underrepresented in this trial, we retrospectively assessed the effectiveness and safety of this regimen in this population. Methods: This retrospective study included patients from 15 centers in LATAM with unresectable or metastatic PM treated with first-line nivolumab plus ipilimumab in a real-world data (RWD) scenario. Demographic, clinicopathological characteristics, and safety data were collected from medical charts. Progression-free survival (PFS), and OS were calculated using the Kaplan-Meier method. Results: From June 2017, and January 2024 96 patients were included: epithelioid 78% (n = 75), 81% were ECOG 0-1 (n = 78). With a median follow-up of 24.1 months, median PFS and OS were 8 months (95% CI, 6.6-9.4), and 22 months (95% CI, 18.9-25), respectively. No statistical difference in OS was observed between epithelioid versus nonepithelioid histology (median 23 months vs. 19 months, respectively; P = .29). Treatment efficacy was also consistent among different clinical subgroups. Any and grade 3-4 adverse events were found in 43.1% (n = 28), and 18.5% (n = 12) of patients, respectively. Remarkably, no OS impact was observed in patients who had dose delay or treatment discontinuation due to immune-related adverse events, and those who experienced any adverse event. Conclusions: This multicenter RWD study demonstrated the clinically meaningful benefit of first-line ipilimumab and nivolumab in LATAM patients with unresectable or metastatic PM, and data is consistent with previous trial findings.
AB - Background: The phase 3 CheckMate-743 trial demonstrated a prolonged overall survival (OS) benefit with nivolumab plus ipilimumab over chemotherapy as first-line treatment in patients with unresectable pleural mesothelioma (PM). However, given that Latin American (LATAM) patients were notably underrepresented in this trial, we retrospectively assessed the effectiveness and safety of this regimen in this population. Methods: This retrospective study included patients from 15 centers in LATAM with unresectable or metastatic PM treated with first-line nivolumab plus ipilimumab in a real-world data (RWD) scenario. Demographic, clinicopathological characteristics, and safety data were collected from medical charts. Progression-free survival (PFS), and OS were calculated using the Kaplan-Meier method. Results: From June 2017, and January 2024 96 patients were included: epithelioid 78% (n = 75), 81% were ECOG 0-1 (n = 78). With a median follow-up of 24.1 months, median PFS and OS were 8 months (95% CI, 6.6-9.4), and 22 months (95% CI, 18.9-25), respectively. No statistical difference in OS was observed between epithelioid versus nonepithelioid histology (median 23 months vs. 19 months, respectively; P = .29). Treatment efficacy was also consistent among different clinical subgroups. Any and grade 3-4 adverse events were found in 43.1% (n = 28), and 18.5% (n = 12) of patients, respectively. Remarkably, no OS impact was observed in patients who had dose delay or treatment discontinuation due to immune-related adverse events, and those who experienced any adverse event. Conclusions: This multicenter RWD study demonstrated the clinically meaningful benefit of first-line ipilimumab and nivolumab in LATAM patients with unresectable or metastatic PM, and data is consistent with previous trial findings.
KW - Checkpoint inhibition
KW - Immunotherapy
KW - Malignant pleural mesothelioma
KW - Nivolumab+Ipilimumab
KW - Real-world
UR - http://www.scopus.com/inward/record.url?scp=85206946527&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2024.09.005
DO - 10.1016/j.cllc.2024.09.005
M3 - Article
C2 - 39424512
AN - SCOPUS:85206946527
SN - 1525-7304
VL - 25
SP - 723-731.e2
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 8
ER -