Title

Pivotal Erivance Basal Cell Carcinoma (Bcc) Study: 12-Month Update Of Efficacy And Safety Of Vismodegib In Advanced Bcc

Keywords

advanced basal cell carcinoma; ERIVANCE BCC study; Hedgehog pathway inhibitor; locally advanced basal cell carcinoma; metastatic basal cell carcinoma; vismodegib

Abstract

Background 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. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.

Publication Date

6-1-2015

Publication Title

Journal of the American Academy of Dermatology

Volume

72

Issue

6

Number of Pages

1021-1026.e8

Document Type

Article

Personal Identifier

scopus

DOI Link

https://doi.org/10.1016/j.jaad.2015.03.021

Socpus ID

84929629820 (Scopus)

Source API URL

https://api.elsevier.com/content/abstract/scopus_id/84929629820

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