Expanded patient access study is under way in U.S. to help expedite availability of Vismodegib for suitable patients.
Genentech and partner Curis reported positive data from a potentially registrational Phase II study with the hedgehog signalling pathway inhibitor vismodegib (RG3616/GDC-0449) in patients with advanced basal cell carcinoma (aBCC). The 104-patient open-label Phase II Erivance BCC study found that treatment with oral vismodegib once-daily significantly improved overall response rate.
Genentech says an expanded patient access study in the U.S. is also under way so the drug can be made available to patients while the firm discusses the next steps in the regulatory process with FDA. Vismodegib is separately being evaluated in a Phase II study in patients with operable forms of BCC.
There are about 2 million cases of BCC globally every year, and despite being the most common type of skin cancer in Europe, Australia, and the U.S, there is currently no approved treatment option for patients with aBCC, Genentech points out. “We look forward to presenting the study data in more detail and discussing the results with global health authorities,” remarks Hal Barron, M.D., Genentech’s CMO and head of global product development.
Vismodegib was discovered by Genentech, and is being developed in collaboration with parent firm Roche and partner Curis. The drug was taken though preclinical evaluation and validation by Roche and Curis, and is progressed through clinical development by Genentech in the U.S., Chugai in Japan, and Roche in the rest of the world. Curis will be eligible for cash payments on the achievement of specific clinical, regulatory, and approval milestones, plus royalties on future sales of the drug. Roche has previously stated that during Q4 2010 it decided to discontinue development of RG3616 for the ovarian and colorectal cancer indications due to lack of benefit in Phase II trials.