Genentech to present positive data from vismodegib Phase II trial on advanced BCC at EADO 2011

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that positive data are being presented by its collaborator Genentech, a member of the Roche Group, from a pivotal Phase II clinical trial conducted by Roche and Genentech of vismodegib (GDC-0449, RG3616) in patients with advanced basal cell carcinoma (BCC), an often life-threatening form of skin cancer that can have disfiguring and debilitating effects. The results will be presented on June 21^st at the Seventh European Association of Dermato-Oncology (EADO) Congress taking place in Nantes, France.

Vismodegib is a first-in-class investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90 percent of BCC cases. Genentech has indicated that it anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) in 2011 to seek approval to commercialize vismodegib based on the positive outcome of this study. Roche has indicated that the timing of a European regulatory submission is subject to planned discussions with the European Medicines Agency (EMA).

"We believe that the strength of the data generated in this clinical study, including the overall response rates observed, demonstrate the potential for vismodegib to have a compelling clinical benefit in treating advanced BCC patients," said Dan Passeri, Curis President and Chief Executive Officer. "Vismodegib has the potential to be an important new treatment for cancer patients with this debilitating condition and we are pleased to see the molecule reach this critical stage of development. We continue to look forward to Genentech and Roche's upcoming regulatory submissions for vismodegib in this patient population."

Vismodegib Pivotal Phase II Results

The primary endpoint of the study is overall response rate as assessed by an independent review facility, with secondary endpoints including investigator-assessed overall response rate, progression-free survival (PFS), overall survival (OS), and duration of response in all evaluable patients, including locally advanced BCC (IaBCC) or metastatic BCC (mBCC) patients. In addition, absence of residual BCC in patients was assessed by sampling biopsies in patients with laBCC.

Genentech had previously reported Phase I clinical trial results in the New England Journal of Medicine in which an investigator-assessed response rate of 55 percent was observed in 33 patients with advanced BCC treated with vismodegib, including those with IaBCC or mBCC. In the pivotal Phase II trial, study investigators assessed the overall response rate to be 55 percent, with 60 percent in the laBCC cohort, and 46 percent in mBCC cohort.

The overall response rate in the pivotal Phase II trial as assessed by an independent review facility showed vismodegib substantially shrank tumors or healed visible lesions, with observed response rates of 43 percent of patients in the laBCC cohort and 30 percent of patients in the mBCC cohort.

The clinical benefit rate (defined as patients who experienced response as well as those who experienced prolonged stable disease for more than 24 weeks) showed vismodegib shrank tumors or healed visible lesions, or prevented them from growing any further in 75 percent of patients with laBCC and 76 percent of patients with mBCC, as assessed by independent review.

The median duration of progression-free survival (PFS) by independent review for both mBCC and laBCC patients was 9.5 months. The median duration of response by independent review was 7.6 months for both mBCC and laBCC patients. The median duration of response as assessed by study investigators was 12.9 and 7.6 months for mBCC and laBCC patients, respectively.

There was no residual BCC in sampling biopsies of 54% of laBCC patients.

As of the November 26, 2010, data cutoff date, there were 19 (57.6%) mBCC and 32 (45.1%) laBCC patients remaining on treatment. The median duration on treatment as of this date was 10 and 9.7 months for mBCC and laBCC patients, respectively.

Source: Curis, Inc.