A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203)
Di Giacomo, Anna Maria (University Hospital of Siena)
Schenker, Michael (Centrul de Oncologie Sf. Nectarie. Oncologie Medicala)
Medioni, Jacques (Université Paris Cité)
Mandziuk, Sławomir (Medical University of Lublin)
Majem Tarruella, Margarita (Institut de Recerca Sant Pau)
Gravis, Gwenaelle (Aix-Marseille Université)
Cornfeld, M. (Incyte Corporation)
Ranganathan, S. (Incyte Corporation)
Lou, Shuyuan (Incyte Corporation)
Csoszi, Tibor (Hetényi Géza Kórház Onkológiai Központ)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	POD1UM-203, an open-label, multicenter, phase II study, evaluated retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in patients with selected solid tumors where immune checkpoint inhibitor therapies have previously shown efficacy. Eligible patients (≥18 years) had measurable disease and included unresectable or metastatic melanoma, treatment-naive metastatic non-small-cell lung cancer (NSCLC) with high programmed death-ligand 1 (PD-L1) expression (tumor proportion score ≥50%), cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (UC) with PD-L1 expression (combined positive score ≥10%), or treatment-naive locally advanced/metastatic clear-cell renal cell carcinoma (RCC). Retifanlimab 500 mg was administered intravenously every 4 weeks as a 30-min infusion. The primary endpoint was investigator-assessed overall response rate. Overall, 121 patients (35 melanoma, 23 NSCLC, 29 UC, 34 RCC) were enrolled and treated. The overall response rate [95% confidence interval (CI)] was 40. 0% (23. 9-57. 9) in the melanoma cohort, 34. 8% (16. 4-57. 3) in the NSCLC cohort, 37. 9% (20. 7-57. 7) in the UC cohort, and 23. 5% (10. 7-41. 2) in the RCC cohort. Median duration of response was 11. 5 months (95% CI 2. 2-not reached) in the UC cohort, and was not reached in the other cohorts. Retifanlimab safety was consistent with previous experience for PD-(L)1 inhibitors. Retifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	PD-1 inhibitor ; Checkpoint inhibitor ; Phase II ; Retifanlimab ; Solid tumor
Publicat a:	ESMO open, Vol. 9 Núm. 3 (march 2024) , p. 102387, ISSN 2059-7029

DOI: 10.1016/j.esmoop.2024.102387
PMID: 38401247

10 p, 404.9 KB

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