Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial

Background: In KEYNOTE-010, pembrolizumab versus docetaxel improved overall survival (OS) in patients with programmed death-1 protein (PD)-L1-positive advanced non-small-cell lung cancer (NSCLC). A prespecified exploratory analysis compared outcomes in patients based on PD-L1 expression in archival...

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Autores: Herbst, R.S. (Roy S.)|||/items/610b8685-37bd-48aa-96b4-c9b77cf7a044, Baas, P. (P.)|||/items/deeb513e-f0ea-4677-bd38-0043265266fa, Perez-Gracia, J.L. (Jose Luis)|||/items/7be82c5d-4858-4e04-bd77-7ef5a883021b, Felip, E. (Enriqueta)|||/items/6153ea5f-76fb-4a96-b0c1-1f296fe60bd7, Kim, D.W|||/items/978c02fc-f8ea-40ef-a565-9ca204c97e80, Han, J.Y. (J. Y.)|||/items/aa371be8-ea80-4983-8fb7-5e64f4e63323, Molina, J.R. (J. R.)|||/items/34f43ac8-f9f3-44f7-a91b-66b1a2fda9c4, Kim, J.H. (J. H.)|||/items/64ed3040-c468-4b75-8084-db16dfda0e50, Dubos-Arvis, C. (C.)|||/items/27a943f6-194c-44e8-9e89-e1c545844cdd, Ahn, M.J. (M. J.)|||/items/72170028-51c0-4de8-8e49-18f95140d251, Majem-Tarruella, M. (Margarita)|||/items/9a152584-75e1-4f83-84d6-b7059eefb96d, Fidler, M.J. (M. J.)|||/items/03e4279b-fad1-4099-b2f5-d551ae6f22df, Surmont, V. (V.)|||/items/ffe62dc4-06c7-4cef-82e7-a42757ad50a7, Castro-Jr, G. (G.) de|||/items/c38432c2-c21b-4ddd-ac27-d09f96fa442d, Garrido, M. (M.)|||/items/92bfbb9e-b9b8-4fbd-b92e-cec5dff96857, Shentu, Y. (Y.)|||/items/0fac4dbe-920b-487d-9ad7-028b693f009e, Emancipator, K. (K.)|||/items/d852638f-39dd-4237-9845-1007e98da7af, Samkari, A. (A.)|||/items/43f7471b-c00d-44fd-92f3-b129bb13465c, Jensen, E.H. (E. H.)|||/items/640f9aca-074b-4e57-8876-094ea8206662, Lubiniecki, G.M (G. M.)|||/items/597049f7-1b6a-4147-83b1-a2d7a90a9b25, Garon, E.B. (E. B.)|||/items/bf360a25-645f-460c-9108-28ed24ee16f3
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/62022
Acceso en línea:https://hdl.handle.net/10171/62022
Access Level:acceso abierto
Palabra clave:Materias Investigacion::Ciencias de la Salud::Oncología
PD-L1 expression
Pembrolizumab
Tumor samples
Descripción
Sumario:Background: In KEYNOTE-010, pembrolizumab versus docetaxel improved overall survival (OS) in patients with programmed death-1 protein (PD)-L1-positive advanced non-small-cell lung cancer (NSCLC). A prespecified exploratory analysis compared outcomes in patients based on PD-L1 expression in archival versus newly collected tumor samples using recently updated survival data. Patients and methods: PD-L1 was assessed centrally by immunohistochemistry (22C3 antibody) in archival or newly collected tumor samples. Patients received pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/m2 Q3W for 24 months or until progression/intolerable toxicity/other reason. Response was assessed by RECIST v1.1 every 9 weeks, survival every 2 months. Primary end points were OS and progression-free survival (PFS) in tumor proportion score (TPS) ≥50% and ≥1%; pembrolizumab doses were pooled in this analysis. Results: At date cut-off of 24 March 2017, median follow-up was 31 months (range 23-41) representing 18 additional months of follow-up from the primary analysis. Pembrolizumab versus docetaxel continued to improve OS in patients with previously treated, PD-L1-expressing advanced NSCLC; hazard ratio (HR) was 0.66 [95% confidence interval (CI): 0.57, 0.77]. Of 1033 patients analyzed, 455(44%) were enrolled based on archival samples and 578 (56%) on newly collected tumor samples. Approximately 40% of archival samples and 45% of newly collected tumor samples were PD-L1 TPS ≥50%. For TPS ≥50%, the OS HRs were 0.64 (95% CI: 0.45, 0.91) and 0.40 (95% CI: 0.28, 0.56) for archival and newly collected samples, respectively. In patients with TPS ≥1%, OS HRs were 0.74 (95% CI: 0.59, 0.93) and 0.59 (95% CI: 0.48, 0.73) for archival and newly collected samples, respectively. In TPS ≥50%, PFS HRs were similar across archival [0.63 (95% CI: 0.45, 0.89)] and newly collected samples [0.53 (95% CI: 0.38, 0.72)]. In patients with TPS ≥1%, PFS HRs were similar across archival [0.82 (95% CI: 0.66, 1.02)] and newly collected samples [0.83 (95% CI: 0.68, 1.02)]. Conclusion: Pembrolizumab continued to improve OS over docetaxel in intention to treat population and in subsets of patients with newly collected and archival samples.

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