Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma

Neoadjuvant ipilimumab plus nivolumab showed high pathologic response rates (pRRs) in patients with macroscopic stage III melanoma in the phase 1b OpACIN ( NCT02437279 ) and phase 2 OpACIN-neo ( NCT02977052 ) studies 1 , 2 . While the results are promising, data on the durability of these pathologic...

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Veröffentlicht in:	Nature medicine 2021-02, Vol.27 (2), p.256-263
Hauptverfasser:	Rozeman, E. A., Hoefsmit, E. P., Reijers, I. L. M., Saw, R. P. M., Versluis, J. M., Krijgsman, O., Dimitriadis, P., Sikorska, K., van de Wiel, B. A., Eriksson, H., Gonzalez, M., Torres Acosta, A., Grijpink-Ongering, L. G., Shannon, K., Haanen, J. B. A. G., Stretch, J., Ch’ng, S., Nieweg, O. E., Mallo, H. A., Adriaansz, S., Kerkhoven, R. M., Cornelissen, S., Broeks, A., Klop, W. M. C., Zuur, C. L., van Houdt, W. J., Peeper, D. S., Spillane, A. J., van Akkooi, A. C. J., Scolyer, R. A., Schumacher, T. N. M., Menzies, A. M., Long, G. V., Blank, C. U.
Format:	Artikel
Sprache:	eng
Schlagworte:	631/250/251 631/67/1813/1634 692/308/2779/109 692/53/2423 Adult Antibodies Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Apoptosis B7-H1 Antigen - antagonists & inhibitors B7-H1 Antigen - genetics B7-H1 Antigen - immunology Biological markers Biomarkers Biomarkers, Tumor - genetics Biomarkers, Tumor - immunology Biomedical and Life Sciences Biomedicine Cancer Research Cell death Clinical trials CTLA-4 Antigen - antagonists & inhibitors CTLA-4 Antigen - genetics CTLA-4 Antigen - immunology Disease-Free Survival Drug therapy Female Gene expression Health aspects Humans Immunotherapy Immunotherapy - adverse effects Infectious Diseases Interferon Interferon-gamma - genetics Ipilimumab Ipilimumab - administration & dosage Ipilimumab - adverse effects Letter Male Melanoma Melanoma - drug therapy Melanoma - immunology Melanoma - pathology Metabolic Diseases Middle Aged Molecular Medicine Monoclonal antibodies Mutation - genetics Neoadjuvant Therapy - adverse effects Neoplasm Staging Neurosciences Nivolumab - administration & dosage Nivolumab - adverse effects Patient outcomes Patients PD-1 protein Recurrence Survival Testing γ-Interferon
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Zusammenfassung:	Neoadjuvant ipilimumab plus nivolumab showed high pathologic response rates (pRRs) in patients with macroscopic stage III melanoma in the phase 1b OpACIN ( NCT02437279 ) and phase 2 OpACIN-neo ( NCT02977052 ) studies 1 , 2 . While the results are promising, data on the durability of these pathologic responses and baseline biomarkers for response and survival were lacking. After a median follow-up of 4 years, none of the patients with a pathologic response ( n = 7/9 patients) in the OpACIN study had relapsed. In OpACIN-neo ( n = 86), the 2-year estimated relapse-free survival was 84% for all patients, 97% for patients achieving a pathologic response and 36% for nonresponders ( P
ISSN:	1078-8956 1546-170X
DOI:	10.1038/s41591-020-01211-7