This article is more than 5 years old. Information may no longer be current.

Erivedge remains efficacious for basal cell carcinoma in 12-month follow-up study

Continued efficacy of Erivedge in patients with advanced basal cell carcinoma was demonstrated in a 12-month follow-up study.

Researchers conducted an efficacy and safety analysis 12 months after a primary analysis of the ERIVANCE basal cell carcinoma (BCC) study, a non-randomized two-cohort trial of 104 patients with locally advanced BCC or metastatic BCC taking oral Erivedge (vismodegib, Genentech; 15 mg/d) in the United States, Europe and Australia. Twenty-nine patients — seven with metastatic BCC and 22 with locally advanced BCC — at the 12-month update analysis cutoff continued treatment.

The FDA’s approval of vismodegib in 2012 for adults with advanced BCC was based on primary analysis of the study, the researchers reported.

Objective response rate, assessed by independent review facility was used as primary outcome measure in the follow-up study.

Median duration of exposure to vismodegib was 12.9 months at the 12-month review. Patients with metastatic BCC had an increase of objective response rate from 30.3% to 33.3% during the follow-up while patients with locally advanced BCC had an increase from 42.9% to 47.6%. The patients with locally advanced BCC had an increase in mediation duration of response from 7.6 months to 9.5 months.

During the extended duration, there were no new safety signals, the researchers reported.

“Results from the 12-month update of the pivotal ERIVANCE BCC study confirm and extend previous observations regarding the efficacy of vismodegib,” the researchers concluded. “These findings … further reinforce the effectiveness of vismodegib as a treatment option for patients with advanced BCC. Follow-up of patients who are still receiving vismodegib treatment on ERIVANCE BCC is ongoing.” – by Bruce Thiel

Disclosure: Sekulic reports serving as an uncompensated consultant for F. Hoffman-LaRoche. Please see the study for a full list of the other researchers’ relevant financial disclosures.