Genentech, Curis Pass Clinical Trial With Skin Cancer Drug, Look Ahead to FDA
Just when it looked like there was nothing much left to say about cancer drugs after the huge ASCO conference a couple weeks ago, here comes Genentech and Curis with another noteworthy result for skin cancer patients.
South San Francisco-based Genentech, and Curis, its partner in Cambridge, MA, said that their experimental drug for a form of skin cancer passed a pivotal trial of 104 patients. The drug, vismodegib, significantly shrank tumors of 43 percent of patients whose basal cell carcinoma had spread in the vicinity of a skin lesion, and for 30 percent of patients whose disease had spread throughout the body, researchers said. The results will be presented in detail tomorrow at the European Association of Dermato-Oncology Congress in France.
Based on the result, Genentech said it plans to discuss the next steps with the FDA.
“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,” said Hal Barron, Genentech’s chief medical officer, in a statement.
The new drug from Genentech and Curis is not only important for patients with basal cell carcinoma, but it also could provide interesting new insights for scientists. The drug is designed to inhibit a biological pathway known as hedgehog. When it becomes abnormally activated, it can send signals that help tumors to grow out of control. Problems in the pathway are thought to be linked to 90 percent of cases of basal cell carcinoma, and to play a role in a number of other tumor types as well. About 2 million people get diagnosed with basal cell carcinoma every year, and while localized lesions it’s almost always curable through surgical removal, tumors that have spread are much tougher to treat.
The trial enrolled patients whose disease had spread locally or throughout the body. There was no control group to compare how patients did on the drug compared to anything else. Patients got the new therapy as a once-daily pill until their disease got worse, or they couldn’t tolerate the side effects. The most commonly reported side effects of the drug were muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite, and diarrhea, Genentech said. Tumors were held in check for a median time of about 9.5 months, the company said.
Curis stock (NASDAQ: CRIS) climbed 2.5 percent to $3.29 at 12:17 pm Eastern time, following the news.