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Jun 20, 2011

Pivotal Study Results Lead Genentech to Project Vismodegib Filing in U.S. During 2011

Pivotal Study Results Lead Genentech to Project Vismodegib Filing in U.S. During 2011

Oral drug improved survival in patients with non-operable basal cell carcinoma.[© M&S Fotodesign -]

  • Curis and partners Roche and the Roche subsidiary Genentech reported positive data from a pivotal Phase II trial with vismodegib (GDC-0449, or RG3616) in the treatment of advanced, inoperable basal cell carcinoma (BCC). The 104-patient Erivance BCC/SHH4476g study showed that treatment with vismodegib resulted in an overall response rate of 55%. Median progression-free survival evaluated by independent review was 9.5 months.

    Curis says Genentech anticipates filing for regulatory approval of vismodegib during 2011. Roche’s application for approval of the drug in Europe will depend on planned discussions with the European Medicines Agency. Roche is separately evaluating vismodegib in a Phase II study in patients with operable forms of BCC.

    The international Phase II Erivance BCC study in inoperable BCC included 71 patients with locally advanced BCC (laBCC) and 33 patients with metastatic BCC (mBCC). The laBCC cancer patients had failed or weren’t suitable for radiotherapy. The trial results showed an overall response rate of 43% for the laBCC patients and 30% for mBCC patients, as assessed by independent review (the primary endpoint). Study investigators assessed the overall response rates at 60% and 46% for the laBCC and mBBC cohorts, respectively (secondary endpoint). The clinical benefit rate, defined as patients who experienced response as well as those who experienced prolonged stable disease for over 24 weeks, showed that vismodegib therapy shrank tumors, healed visible lesions, or prevented further lesion growth in 75% of patients, as assessed by independent review.

    Vismodegib is an oral compound designed to selectively inhibit Hedgehog pathway signaling, which is implicated in over 90% of BCC cases, Curis notes. The candidate was originally discovered by Genentech, and jointly validated in collaboration with Curis through preclinical studies. Clinical development of vismodegib is being carried out by Genentech in the U.S., Chugai in Japan, and Roche in the rest of the world.

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