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Roche Holdings Ltd. ( RHHBY ) reported positive results from a mid-stage trial on vismodegib. The candidate is being evaluated for the treatment of advanced basal cell carcinoma (BCC). The phase II trial (ERIVANCE BCC) involved patients whose lesions could not be operated, or for whom surgery would result in substantial deformity.
The study, which enrolled 104 patients with advanced BCC including 71 patients with locally advanced BCC (laBCC) and 33 patients with metastatic BCC (mBCC), demonstrated that vismodegib substantially shrank tumors or healed visible lesions in 43% of patients with laBCC and 30% of patients with mBCC. The median duration of progression-free survival (PFS) was 9.5 months.
Moreover, 75% of the patients in the study experienced tumor shrinkage or healing of visible lesions, or a reduction on further growth of tumors and lesions, according to the clinical benefit rate (patients who experienced response as well as prolonged stable disease for more than 24 weeks).
Roche has a collaboration agreement with Curis Inc. ( CRIS - Snapshot Report ) for vismodegib. According to the agreement, Roche is responsible for developing and commercializing vismodegib worldwide excluding Japan, where the charge lies with Chugai Pharmaceuticals. Curis is eligible to receive payments upon the achievement of certain clinical development and regulatory milestones. Curis will also receive royalties upon commercialization of vismodegib.
BCC is a form of skin cancer, which can cause disfiguring and debilitating effects that can ultimately lead to death. The disease is generally curable when the cancer affects only a small area of the skin. However, if the disease is left untreated or does not respond to treatment, the cancer may spread further. In such cases, it becomes life-threatening.
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