Amgen publishes pivotal T-Vec data as it awaits FDA decision
Riding momentum from an FDA advisory committee recommendation last month, Amgen ($AMGN) rolled out its data from a pivotal study of its cancer vaccine talimogene laherparepvec (T-Vec) on Tuesday as it awaits the agency's final decision, expected later this year.
Data from the 400-patient Phase III study, dubbed OPTiM, were published Tuesday in the Journal of Clinical Oncology, demonstrating T-Vec to have a "significantly higher" durable response rate compared with patients who received granulocyte-macrophage colony-stimulating factor (GM-CSF), Amgen said in its statement.
The news comes just a month after T-Vec was recommended 22-1 by an FDA advisory committee in which many members noted the treatment could serve as another "arrow in the quiver" for treating melanoma--a cancer that caused 9,710 deaths last year.
|Amgen R&D chief Sean Harper|
"While there have been some important new treatment options in recent years, the incidence of melanoma has risen dramatically, and we need additional approaches for treating advanced disease," Amgen R&D chief Sean Harper said in a statement. "The OPTiM trial data provide strong evidence supporting the local and distant effects of talimogene laherparepvec and its potential to stimulate a systemic anti-tumor immune response."
The data serve as the basis of T-Vec's FDA and EU applications, with the FDA on the hook for a decision by Oct. 27. Despite meeting the primary endpoint in the trial, T-Vec fell short of its secondary endpoint of overall survival, though Amgen noted that there was a strong trend in favor of the candidate.
T-Vec, an oncolytic immunotherapy, is engineered to cause cell lysis by replicating in tumors, thus activating an antitumor immune response. Amgen's seeking to make it just the second approved cancer vaccine in a troubled field behind Provenge, seen as a potential blockbuster when it won approval in 2010. But a high price tag, manufacturing issues and competition eventually led the shot's maker Dendreon to declare bankruptcy. Valeant ($VRX) picked up the company and Provenge last year for $400 million.
- here's the abstract
- here's the release
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