Roche’s skin cancer drug passes mid-stage trial
pharmafile | March 22, 2011 | News story | Research and Development | Curis, Roche, advanced basal cell carcinoma, skin cancer, vismodegib
Roche’s skin cancer candidate vismodegib has met its primary endpoint in a phase II trial.
The drug is being tested to treat advanced basal cell carcinoma (aBCC), the most common type of skin cancer.
There are currently no targeted drugs for aBCC, with treatment restricted to surgery and chemotherapy, so Roche’s highly novel targeted drug could have a first-to-market advantage if it makes it through the development process.
Hal Barron, chief medical officer at Roche, said: “These results are important because people with this disfiguring and potentially life-threatening advanced form of skin cancer currently have no approved treatment options.
“We look forward to presenting the study data in more detail and discussing the results with global health authorities.”
Vismodegib works by inhibiting the ‘Hedgehog pathway’, which is the leading cause of BCC cases.
The Hedgehog signalling pathway plays an important role in regulating proper growth and development in the early stages of life and then becomes less active in adults, but mutations caused by exposure to sunlight can reactivate it.
The drug met its trial endpoint of overall response rate, shrinking tumours in a pre-defined percentage of people in the study.
Roche said based on these results it would look to submit the drug later this year as there are so few treatments available for aBCC.
A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib, although there were a number of fatalities that are currently being evaluated.
Roche said full data of the results would be available at an upcoming medical meeting.
BCC predominantly occurs in the central area of the face and is a slow growing tumour with a relatively low mortality rate.
This is in contrast with melanoma, the deadliest form of skin cancer, that tends to metastasis, making treatment difficult and prognosis poor.
Roche is currently developing RG7204 for metastatic melanoma and that drug has also impressed in a recent phase III trial.
The Swiss oncology specialist is collaborating on vismodegib’s development with US biotech specialist Curis.
Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialisation of vismodegib.
Ben Adams
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