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

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.