Odomzo (sonidegib)

Accordingly, current targeted therapies for locally advanced, unresectable, or metastatic BCC focus on SMO inhibition, using orally administered drugs such as vismodegib and sonidegib. To our knowledge, this is the first report documenting a sonidegib resistance mechanism in BCC that is independent of HH pathway mutations. This case highlights the complexity of resistance mechanisms to HH inhibitors and underscores the critical need for comprehensive molecular tumor profiling prior to initiating targeted therapy.

Targeted therapies of lapatinib, fulvestrant, and endocrine agents (letrozole or ribociclib) show disproportionately high AE reporting odds ratios, necessitating vigilant monitoring. HER2-positive BC treatments (trastuzumab) and TNBC agents (sonidegib) exhibit distinct risk profiles, advocating for personalized risk-benefit assessments for BC patients.

P2, N=16, Completed, Melanoma Institute Australia | Recruiting --> Completed | Trial completion date: Jun 2026 --> Mar 2025 | Trial primary completion date: Jun 2026 --> Mar 2025

P2, N=20, Recruiting, Melanoma Institute Australia | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026

Rarely, this condition is related to a suppressor of fused gene mutation, which occurs downstream from Smoothened, and is unresponsive to Smoothened inhibitors including vismodegib and sonidegib. Genetic testing was negative for patched 1 and patched 2 mutations but positive for a heterozygous suppressor of fused mutation. Patients with basal cell nevus syndrome should be treated with surgical excision, counseled on sun protection, screened and monitored for complications, and treated with vismodegib (if associated with patched 1 mutation) or itraconazole (if associated with suppressor of fused mutation).

P2, N=20, Terminated, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Dec 2025 --> Sep 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2025; Poor accrual

P4, N=160, Completed, Jemincare | Active, not recruiting --> Completed

P2, N=20, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025

P=N/A, N=12, Completed, Federico II University

P=N/A, N=323, Completed, Sun Pharmaceutical Industries Limited | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Mar 2025

P2, N=12, Suspended, University of Florida | Recruiting --> Suspended

Furthermore, the expression analysis utilizing inhibitors such as GANT-61 (GLI1 inhibitor) and Sonidegib (SMO inhibitor) have demonstrated that the MSN-PG-HA has shown a significant level of inhibition as that of GANT-61, indicating a similarity in their mechanism of action in inhibiting the cancer cell proliferation. Thus, our findings conclude that MSN-PG-HA could serve as a potential drug for targeting GI cancer stem cells.