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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
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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

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