Italian interim analysis of NISSO: long-term sonidegib safety in locally advanced basal cell carcinoma.

Abstract

Background: Following the pivotal Phase II BOLT trial, sonidegib was approved by EMA to treat laBCC in patients not amenable to surgery or radiotherapy.

Methods: The NISSO study (NCT04066504) is a non-interventional, multinational, multi-center, long-term, post-authorization, real-world safety study. Patients with laBCC were treated with sonidegib 200 mg orally once-daily and followed for 3 years according to the Prescribing Information.

Results: Ninety-three patients were enrolled at 12 Italian centers with a median age of 79. The median exposure to sonidegib exposure was 8.9 months. At the time of the analysis, treatment ended in 65.6% patients, mainly due to patient/guardian decision, treatment success and physician decision. Most patients (78.5%) experienced at least 1 treatment-emergent adverse event (TEAE) including muscle spasms (39.8%), dysgeusia (32.3%), fatigue (21.5%); all of them decreased substantially after 3 months. Most TEAEs were Grade 1 and led to treatment discontinuation in 12.9%, while serious drug-related TEAEs were reported in 2.1% of patients. The Italian interim analysis shows a better real-world safety profile than could be expected based on the pivotal BOLT trial. Most patients experienced the onset of common AEs after 3 months.

Conclusions: All the above supports the use of sonidegib as a manageable first-line systemic treatment in patients with laBCC.