ASCO 2013: Positive Phase III data for T-VEC gives Amgen strong approval outlook.
By Aine Slowey, Lead Analyst
6 June 2013
I am the Lead Analyst for cardiovascular and metabolic diseases at Datamonitor Healthcare. I have a DPhil in Organic Che...
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On June 1, 2013, Dr Robert Andtbacka presented the results of T-VEC’s (talimogene laherparepvec; Amgen) Phase III clinical trial for unresected Stage IIIB/C and IV melanoma. T-VEC met the primary endpoint of its Phase III OPTiM trial by demonstrating acceptable durable response rates in patients with unresected Stage IIIB/C melanoma or Stage IV melanoma with limited visceral burden.
T-VEC is the first in a new class of anti-cancer agents to demonstrate clinical activity in a late-stage clinical trial for melanoma and may transform the treatment of melanoma patients with non-visceral disease. T-VEC met the primary endpoint of its Phase III OPTiM trial by demonstrating acceptable durable response rates in patients with unresected Stage IIIb/c or Stage IV melanoma with limited visceral burden. In the trial, 436 patients were randomized 2:1 to receive either T-VEC or granulocyte-macrophage colony-stimulating factor (GM-CSF).
This also features a tablular summary of ongoing clinical trials for oncolytic viruses in development and the indications being focused on by developers.