A Roche Holding AG skin cancer drug reduced the size and number of growths in people genetically predisposed to the disease in a study published today, even as half the participants quit because of side effects.
Erivedge, also known as vismodegib, reduced the rate of new basal cell carcinomas to two per year, compared with 29 new growths in patients who got a placebo, according to results published today in the New England Journal of Medicine. The Roche pill shrank existing growths in the study.
“It is a landmark day for patients with basal-cell carcinoma and all those involved in their care,” John Lear, a consultant dermatologist at Manchester Royal Infirmary, wrote in an editorial accompanying the studies. Lear called Erivedge “the greatest advance in therapy yet seen for this disease.”
The study followed 41 patients with basal-cell nevus syndrome, or Gorlin syndrome, a rare hereditary disorder caused by a malfunctioning gene. Patients can have thousands of lesions, in some case losing ears and eyes to the disease, Lear said.
Yet the 54 percent drop-out rate for patients with such a serious form of the disease shows that a more targeted topical therapy -- a cream or injected medicine -- may be helpful to bring the treatment to a wider group of patients, Lear said.
Topical and injected approaches have been discussed in the past for Erivedge but haven’t been successful, Daniel Grotzky, a spokesman for Basel, Switzerland-based Roche, said by e-mail.
Side effects of Erivedge include losing one’s sense of taste, muscle cramps, loss of hair and weight loss.
Erivedge was approved in the U.S. in January for advanced basal cell carcinoma. The New England journal also published a detailed analysis of the study in locally advanced and metastatic basal cell carcinoma that was the basis for regulators’ approval.
Roche is studying the medicine in a mid-stage trial of people with operable basal cell carcinoma, Grotzky said.
Roche is developing Erivedge under an agreement with Lexington, Massachusetts-based Curis Inc.