Curis, a drug development company focusing on next-generation targeted small molecule drug candidates for cancer treatment, announced a positive outcome from a pivotal phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly-owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC).
Genentech reported the study met its primary endpoint of achieving a target overall response rate, showing GDC-0449 shrank advanced BCC tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib.
Genentech plans to submit the data from the clinical trial for presentation at a future medical meeting.
Roche said GDC-0449 (also known as RG3616) now has a generic name approved by the World Health Organization, vismodegib.