Mid-stage trial boost for Roche skin cancer drug vismodegib
pharmafile | June 20, 2011 | News story | Research and Development | Cancer, Roche, skin cancer, vismodegib
Roche’s novel skin cancer drug vismodegib has met its primary endpoint in a phase II trial.
Vismodegib is an investigational, oral treatment designed to selectively inhibit signalling in the Hedgehog pathway, which is implicated in more than 90% of basal cell carcinoma (BCC) cases.
Vismodegib substantially shrank tumours or healed visible lesions (overall response rate) in 43% of patients with locally advanced BCC.
It also achieved an overall response rate in 30% of patients whose cancer had metastasised in the ERIVANCE BCC study.
It’s the second recent boost for Roche’s skin cancer portfolio, after late stage trials of vemurafenib in previously untreated BRAF V600 mutation-positive metastatic melanoma impressed at the recent ASCO cancer conference in Chicago.
There are currently no targeted drugs for the form of advanced BCC vismodegib targets, so Roche’s highly novel targeted drug could have a first-to-market advantage if it makes it through the development process.
The Swiss cancer specialist says it is now in discussion with the EMA for the next steps needed to get the drug to market swiftly.
Hal Barron, head of global product development, said: “Vismodegib is an example of our commitment to understanding and developing medicines that target the biologic cause of a particular disease.
“Our goal is to provide a medicine to people with this rare and disfiguring form of advanced skin cancer as soon as possible, and we are discussing these results with global regulatory authorities.”
The most common drug related adverse events were muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhoea.
BCC is the most common type of skin cancer, but the least likely to spread to other parts of the body.
It can however cause disfiguring and disabling ailments and ultimately, if left untreated, can metastasise and cause death in around 1% of patients.
Roche 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.
Full results of the ERIVANCE BCC study will be presented tomorrow at the Seventh European Association of Dermato-Oncology Congress taking place in Nantes, France.
Ben Adams
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