Vismodegib is safe and effective in the management of advanced basal cell carcinoma (BCC), according to a study published in the Journal of the American Academy of Dermatology.
In a multinational, multicenter, nonrandomized, two-cohort study, researchers led by Aleksander Sekulic, MD, of the Mayo Clinic looked at patients with measurable and histologically confirmed locally advanced or metastatic BCC who took oral vismodegib.
Primary outcome was objective response rate, both complete and partial, which was assessed by an independent review facility.
The researchers found that after 12 months of primary analysis, median duration of exposure to vismodegib was 12.9 months. In patients with metastatic disease, objective response rate increased from 30.3 percent to 33.3 percent, while in those with locally advanced disease, it increased from 42.9 percent to 47.6 percent.
In addition, median duration of response in patients with locally advanced disease increased from 7.6 to 9.5 months.
“The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC,” the authors concluded.
Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation.