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Ref Type Journal Article
PMID (38417447)
Authors Larkin J, Marais R, Porta N, Gonzalez de Castro D, Parsons L, Messiou C, Stamp G, Thompson L, Edmonds K, Sarker S, Banerji J, Lorigan P, Evans TRJ, Corrie P, Marshall E, Middleton MR, Nathan P, Nicholson S, Ottensmeier C, Plummer R, Bliss J, Valpione S, Turajlic S
Title Nilotinib in KIT-driven advanced melanoma: Results from the phase II single-arm NICAM trial.
Journal Vol Issue Date Pages Journal Short Title
Cell reports. Medicine 5 3 2024 Mar 19 101435 Cell Rep Med
URL
Abstract Text 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).

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KIT mutant mucosal melanoma predicted - sensitive Nilotinib Phase II Actionable In a Phase II trial (NICAM), Tasigna (nilotinib) treatment demonstrated activity in patients with acral (n=6) or mucosal melanoma (n=20) harboring KIT mutations, resulting in a progression-free survival at 6 months in 25% (6/24) of the patients, a median-progression free survival of 3.7 months, objective response rate at 12 weeks of 19% (5/26), and median overall survival of 7.7 months (PMID: 38417447). 38417447
KIT mutant acral lentiginous melanoma predicted - sensitive Nilotinib Phase II Actionable In a Phase II trial (NICAM), Tasigna (nilotinib) treatment demonstrated activity in patients with acral (n=6) or mucosal melanoma (n=20) harboring KIT mutations, resulting in a progression-free survival at 6 months in 25% (6/24) of the patients, a median-progression free survival of 3.7 months, objective response rate at 12 weeks of 19% (5/26), and median overall survival of 7.7 months (PMID: 38417447). 38417447
KIT D820V mucosal melanoma predicted - sensitive Nilotinib Case Reports/Case Series Actionable In a Phase II trial (NICAM), Tasigna (nilotinib) treatment demonstrated activity in patients with acral (n=6) or mucosal melanoma (n=20) harboring KIT mutations, resulting in an objective response rate at 12 weeks of 19% (5/26), including a mucosal melanoma patient harboring KIT D820V, who had a 38.1% reduction of target lesions, remained on treatment for 54.2 months, with a progression-free survival of 15.6 months, and overall survival of 63.7 months (PMID: 38417447). 38417447