Nilotinib in KIT-driven advanced melanoma: Results from the phase II single-arm NICAM trial
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Authors
Larkin, J.Marais, Richard
Porta, N.
de Castro, D. G.
Parsons, L.
Messiou, C.
Stamp, G.
Thompson, L.
Edmonds, K.
Sarker, S.
Banerji, J.
Lorigan, Paul
Evans, T. R. J.
Corrie, P.
Marshall, E.
Middleton, M. R.
Nathan, P.
Nicholson, S.
Ottensmeier, C.
Plummer, R.
Bliss, J.
Valpione, Sara
Turajlic, S.
Affiliation
Cancer Research UK Manchester Institute, The University of Manchester, Manchester, UK; Division of Cancer Sciences, Unviersity of Manchester, Manchester; The Christie NHS Foundation Trust, Manchester, UKIssue Date
2024
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Mucosal (MM) and acral melanomas (AM) are rare melanoma subtypes of unmet clinical need; 15%-20% harbor KIT mutations potentially targeted by small -molecule inhibitors, but none yet approved in melanoma. This multicenter, single -arm Phase II trial (NICAM) investigates nilotinib safety and activity in KIT mutated metastatic MM and AM. KIT mutations are identified in 39/219 screened patients (18%); of 29/39 treated, 26 are evaluable for primary analysis. Six patients were alive and progression free at 6 months (local radiology review, 25%); 5/26 (19%) had objective response at 12 weeks; median OS was 7.7 months; ddPCR assay correctly identifies KIT alterations in circulating tumor DNA (ctDNA) in 16/17 patients. Nilotinib is active in KIT -mutant AM and MM, comparable to other KIT inhibitors, with demonstrable activity in nonhotspot KIT mutations, supporting broadening of KIT evaluation in AM and MM. Our results endorse further investigations of nilotinib for the treatment of KIT -mutated melanoma. This clinical trial was registered with ISRCTN (ISRCTN39058880) and EudraCT (2009-012945-49).Citation
Larkin J, Marais R, Porta N, de Castro DG, Parsons L, Messiou C, et al. Nilotinib in KIT-driven advanced melanoma: Results from the phase II single-arm NICAM trial. CELL REPORTS MEDICINE. 2024 MAR 19;5(3). PubMed PMID: WOS:001217979200001. English.Journal
Cell Reports MedicineDOI
10.1016/j.xcrm.2024.101435PubMed ID
38417447Additional Links
https://dx.doi.org/10.1016/j.xcrm.2024.101435Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.xcrm.2024.101435