Roche and partner Curis' investigational skin cancer drug vismodegib has turned in encouraging performance in a Phase II clinical trial, so much so that the drug could be filed for approval in the US sometime this year.
The 104-patient, Phase II ERIVANCE BCC study showed that vismodegib substantially shrank tumours or healed visible lesions, with response rates of 43% of patients in the locally advanced basal cell carcinoma (BCC) cohort and 30% of those in the metastatic BCC arm, according to an independent review.
In addition, the clinical benefit rate - i.e. patients who responded e as well as those in whom the disease was stable more than 24 weeks - showed that the drug shrank tumors or healed visible lesions or prevented their further growth in 75% of patients with locally advanced BCC and 76% of those with metastatic disease.
The most common drug related adverse events were found to be muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhoea. Seven patients (7%) died during the trial, though none of the cases were considered by investigators to be related to vismodegib.
"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, president and chief executive officer of Curis, and added that the drug has the "potential to be an important new treatment for cancer patients".
With around 2 million new cases every year, BCC is the most common cancer in the US and the most common type of skin cancer. Vismodegib is a first-in-class investigational, oral medicine that works by selectively inhibiting signaling in the Hedgehog pathway, which is implicated in more than 90% of BCC cases.
Based on the the drug's promising performance in the Phase II trial, Genentech has indicated that it plans to file the drug with the US Food and Drug Administration this year, while in Europe the timing of a European submission by Roche is subject to discussions with the European Medicines Agency.