Final safety and efficacy results for vismodegib were reported at the Society for Melanoma Research, 2014 International Congress, for the 30-month mark of the ERIVANCE trial. The Congress is meeting November 13-16 in Zurich, Switzerland.
Final safety and efficacy results for vismodegib were reported at the Society for Melanoma Research, 2014 International Congress for the 30-month mark of the ERIVANCE trial. The Congress is meeting November 13-16 in Zurich, Switzerland.
Vismodegib, marketed as Erivedge, is recommended for patients with advanced basal cell carcinoma (BCC) for whom surgery or radiation are no longer options. In the ERIVANCE trial, vismodegib, a Hedgehog pathway inhibitor, showed objective response rates (ORR) by an independent review of 30% in metastatic BCC and 43% in locally advanced BCC.
ORRs, by an investigator review, were 45% for metastatic BCC and 60% for locally advanced BCC, with a median duration of response of 12.9 and 7.6 months, respectively. Safety and efficacy results represent data at 30 months ending May 30, 2013, following primary analysis on November 26, 2010. At the start of the study, 104 patients had radiographically measurable metastatic BCC or locally advanced BCC (with surgery inappropriate due to multiple recurrence, or substantial morbidity or deformity foreseen). Patients received 150 mg of oral vismodegib once a day until disease progression or intolerable toxicity.
Secondary endpoints included ORR, DOR, progression-free survival (PFS), overall survival, and safety. The study examined subsets of patients to determine if there were different treatment effects. At the time of the data cutoff, 8 patients were receiving the study drug and undergoing protocol assessments, with 69 patients in survival follow-up. The overall response rate was 48.5% for metastatic BCC, and 60.3% for locally advanced BCC, with 20 complete responses and 18 partial responses. Median PFS was higher among the patients with locally advanced BCC than those with metastatic BCC. Overall survival for metastatic BCC was 33.4 months. Adverse events were consistent with those previously reported in the primary analysis, and 17 deaths—not considered drug-related—were reported since that time, during survival follow-up. Results confirm previously reported long-term safety of vismodegib for patients with advanced BCC.
Sekulic A., Migden M., Basset-Seguin N, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma (aBCC): final update (30-month) of the pivotal ERIVANCE BCC study. Presented at Society for Melanoma Research, 2014 International Congress, November 13-16, 2014, Zurich, Switzerland.