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.

The data published were for T-Vec as a solo treatment, but Amgen is additionally testing it in combination with immunotherapies from Bristol-Myers Squibb ($BMY) and Merck ($MRK).

- here's the abstract
- here's the release

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