Erivedge vismodegib: Interim Phase Ib/II data
Interim data from 70 evaluable patients with recurrent or metastatic pancreatic cancer in a double-blind, U.S. Phase Ib/II trial showed that once-daily 150 mg oral vismodegib plus gemcitabine led to a median PFS of 3.7 months vs. 2.4 months for placebo plus gemcitabine. There were no complete or partial responses and 49 cases of stable disease in patients receiving vismodegib vs. 3 complete responses, 11 partial responses and 31 cases of stable disease in patients receiving placebo. Upon disease progression, 23 of 35 patients in the placebo group crossed over to receive vismodegib. Median OS was 6.3 months for patients receiving vismodegib vs. 5.4 months for placebo, and 1-year OS was 24% for both arms. Grade 3/4 adverse events included neutropenia, hyponatremia, fatigue, hyperglycemia and elevated alkaline phosphatase (ALP) levels. The University of Chicago sponsored the trial, which was funded by NIH's National Cancer Institute (NCI). Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...