An experimental drug sonidegib (LDE225) appears to markedly shrink tumors in patients with advanced basal cell carcinoma according to results recently presented at the 2014 annual meeting of the American Society of Clinical Oncology.1

Basal cell carcinoma is the most commonly diagnosed type of skin cancer. Most cases can be treated with surgery or other types of local treatment and are not life-threatening, but the condition often occurs on the face and can be disfiguring. In the most severe cases, the cancer may be very large, may invade structures other than the skin, or may spread to other parts of the body. In these advanced cases, it may not be possible to surgically remove the cancer, and treatment options are limited. The number of people with basal cell cancer is on the rise as the population ages and people become increasingly exposed to ultraviolet rays.

This Phase II trial was designed to assess the safety and efficacy of two oral doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma. The researchers reported that patients had marked and sustained shrinkage of the cancer after a median follow-up of 13.9 months.

The US Food and Drug Administration (FDA) recently approved the targeted therapy Erivedge™ (vismodegib) for the treatment basal cell carcinoma of the skin that has spread to other parts of the body or that is locally advanced and cannot be treated with surgery or radiation.2  Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma.  While additional studies will be ongoing to determine the correct dose and schedule of LDE225, this has the potential to represent another advance in the management options for patients impacted by basal cell cancers.


1. Migden M, Guminiski A, Gutzmer R, et al. Randomized, double-blind study of sonidegib (LDE225) in patients with locally advanced or metastatic basal-cell carincinoma (BCC). J Clin Oncol 32:5s, 2014 (suppl; abstr 9009a)

2. Dirix L, Migden MR, Oro AE et al. A pivotal multicenter trial evaluating efficacy and safety of the Hedgehog pathway inhibitor (HPI) vismodegib in patients with advanced basal cell carcinoma (BCC). Presented at the 2011 European Multidisciplinary Cancer Conference. Stockholm, Sweden. September 23-27, 2011. Abstract LBA1.

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