Genentech announced a Phase II study with vismodegib showed positive results in people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.
Vismodegib is an investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90% of BCC cases.
The trial showed vismodegib substantially shrank tumors or healed visible lesions (overall response rate) in 43% of patients with locally advanced BCC (laBCC) and 30% of patients with metastatic BCC (mBCC), the primary endpoint, as assessed by independent review.. The most common drug-related adverse events were muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite, and diarrhea.
“Our goal is to provide a medicine to people with this rare and disfiguring form of advanced skin cancer as soon as possible, and we are discussing these results with global regulatory authorities,” says Hal Barron, MD, chief medical officer and head of global product development.
Release Date: June 19, 2011
Filed Under: Drug Discovery