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

Vismodegib fails to meet primary efficacy endpoints for treatment of patients with BCC

Erivedge did not meet primary efficacy endpoints of predefined histologic clearance rates in patients with basal cell carcinoma who received the treatment prior to excision; however, drug-related adverse events were reversible upon treatment completion, according to recently published study results.

Researchers studied 74 patients with new, operable, nodular basal cell carcinoma (BCC) who received Erivedge (vismodegib, Genentech) 150 mg per day followed by excision and Mohs micrographic surgery between Oct. 5, 2010, and Nov. 29, 2012. The patients were divided into three cohorts: 24 patients received vismodegib for 12 weeks (cohort one), 25 patients received vismodegib for 12 weeks followed by 24 weeks of observation prior to excision (cohort two), and 25 patients received vismodegib for 8 weeks on/4 weeks off/8 weeks on (cohort three).

Complete histologic clearance (CHC) was achieved by 42% in cohort one and 44% in cohort three, which did not meet the predefined CHC rate of more than 50%. CHC was achieved by 16% of patients in cohort two, which did not meet the predefined CHC rate of more than 30%.

Seventy-three patients developed treatment-emergent adverse events (AEs). The most frequent AEs were muscle spasms (76%), alopecia (58%) and dysgeusia (50%), with five patients (7%) discontinuing treatment because of AEs.

Reversibility of AEs was examined in cohort two, which had a longer observation period following treatment. Within this cohort, 16 of 19 patients with muscle spasms achieved full resolution within 6 weeks of the end of treatment, and patients with alopecia and dysgeusia achieving resolution within 12 weeks of the end of treatment, according to the researchers. – by Bruce Thiel

Disclosures: Sofen reports being an advisory board member, consultant, investigator and speaker for Genentech, receiving honoraria. Please see the full study for a list of all other authors’ relevant financial disclosures.