Vical melanoma drug dropped
pharmafile | August 13, 2013 | News story | Research and Development, Sales and Marketing | Vical, allovectin, melanoma
Vical has abandoned trials of a late-stage drug for the deadliest form of skin cancer after the treatment failed to beat chemotherapy.
The Phase III trial of just under 400 patients failed to demonstrate a statistically significant improvement when compared to first-line chemotherapy, for both the objective response rate at 24 weeks and the secondary endpoint of overall survival.
The late-stage trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, was being studied in patients with metastatic melanoma.
The San Diego, US firm said that its trial data will be further analysed and detailed results will be submitted for publication.
“We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed,” said Vijay Samant, president and chief executive of Vical.
“Based on this outcome, we are terminating the Allovectin programme and focussing our resources on our infectious disease vaccine programmes.”
Samant added: “We would like to recognise all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts.”
There have been a number of new melanoma drugs to hit the market in the past two years, with Bristol-Myers Squibb’s cancer vaccine Yervoy and Roche’s Zelboraf pill, and more recently GlaxoSmithKline’s two melanoma drugs Tafinlar and Mekinist.
But before the approval of Yervoy in March 2011 there had not been a new treatment for the disease in 40 years, showing just how difficult trials for this growing disease can be.
Infectious disease
Oncology is not the only area that Vical is focusing on as it has several independent and collaborative programmes for infectious disease vaccines.
The two of these – for herpes simplex virus (HSV) and cytomegalovirus (CMV) – have not entered clinical trials.
One of Vical’s collaborations is with Japan’s Astellas Pharma for a vaccine intended to control CMV in transplant recipients, which began a late-stage trial in June.
Ben Adams
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