Dr. Andtbacka Reviews the Efficacy of T-VEC in Melanoma

Robert H. I. Andtbacka, MD
Published: Friday, Jun 07, 2013

Robert Andtbacka, MD, a surgeon and investigator with Intermountain Healthcare and Huntsman Cancer Institute, provides an overview of the phase III OPTiM trial that explored treatment with talimogene laherparepvec (T-VEC) in patients with advanced melanoma.

In the trial, 436 patients with unresected stage IIIB/C and IV melanoma were randomized 2:1 to intralesional T-VEC or subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the trial was durable response rate (DRR), which was defined to include a continuous partial or complete response for greater than 6 months. Overall, patients treated with T-VEC experienced a DRR of 16% compared to 2% for GM-CSF.

The secondary endpoint of the trial was overall survival (OS), Andtbacka notes. At a planned interim analysis a trend toward an improvement in OS was observed in favor of T-VEC, with a hazard ratio of 0.79 (95% CI: 0.61, 1.02). This analysis was derived from 250 of the planned 290 events with a full analysis expected later this year.
 
Robert Andtbacka, MD, a surgeon and investigator with Intermountain Healthcare and Huntsman Cancer Institute, provides an overview of the phase III OPTiM trial that explored treatment with talimogene laherparepvec (T-VEC) in patients with advanced melanoma.

In the trial, 436 patients with unresected stage IIIB/C and IV melanoma were randomized 2:1 to intralesional T-VEC or subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the trial was durable response rate (DRR), which was defined to include a continuous partial or complete response for greater than 6 months. Overall, patients treated with T-VEC experienced a DRR of 16% compared to 2% for GM-CSF.

The secondary endpoint of the trial was overall survival (OS), Andtbacka notes. At a planned interim analysis a trend toward an improvement in OS was observed in favor of T-VEC, with a hazard ratio of 0.79 (95% CI: 0.61, 1.02). This analysis was derived from 250 of the planned 290 events with a full analysis expected later this year.
 



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