التفاصيل البيبلوغرافية
| العنوان: |
Nilotinib in KIT-driven advanced melanoma: Results from the phase II single-arm NICAM trial |
| المؤلفون: |
Larkin, James, Marais, Richard, Porta, Nuria, Gonzalez de Castro, David, Parsons, Lisa, Messiou, Christina, Stamp, Gordon, Thompson, Lisa, Edmonds, Kim, Sarker, Sarah, Banerji, Jane, Lorigan, Paul, Evans, Thomas R. Jeffry, Corrie, Pippa, Marshall, Ernest, Middleton, Mark R., Nathan, Paul, Nicholson, Steve, Ottensmeier, Christian, Plummer, Ruth, Bliss, Judith, Valpione, Sara, Turajlic, Samra |
| المصدر: |
Cell Reports Medicine; March 2024, Vol. 5 Issue: 3 |
| مستخلص: |
Mucosal (MM) and acral melanomas (AM) are rare melanoma subtypes of unmet clinical need; 15%–20% harbor KITmutations 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 KITmutated metastatic MM and AM. KITmutations 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 KITalterations 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 KITmutations, supporting broadening of KITevaluation 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). |
| قاعدة البيانات: |
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