June 1, 2013

$PVCT: $AMGN's T-Vex Abstract at #ASC02013

Amgen's abstract for intralesional agent talimogene laherparepvec's (T-Vec's) Phase 3 trial is now available.

Good for T-Vec and Amgen is good for PV-10 and Provectus.

The study author is Robert Andtbacka, M.D., assistant professor, University of Utah Huntsman Cancer Institute. Dr. Andtbacka presented information comparing Phase 2 response rate data of T-Vec with PV-10 and other intralesional agents in March 2013 for injected lesions, non-injected lesions and non-injected systemic lesions.

Amgen's press release is here.

"The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR with 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm (95 percent CI, 12-21 percent, versus 95 percent CI, 0-5 percent, p<0.0001). The overall response rate was 26 percent with talimogene laherparepvec as compared to six percent for GM-CSF.  A trend toward overall survival (HR = 0.79, 95 percent CI, 0.61-1.02) was also observed at a predefined interim analysis."

"In regionally and distantly metastatic melanoma (stages III and IV), cancer has spread to skin, lymph nodes, or to other organs distant from the site of origin. The DRR was highest among patients with stage III and stage IVM1a disease. The observed DRR for talimogene laherparepvec were: 33 percent in stage IIIB/IIlC, 16 percent in stage IVM1a, and three and eight percent respectively for stages IVM1b and IVM1c. The DRR with GM-CSF was not higher than four percent in any of the stage subsets."

""Over the last 30 years, the incidence of metastatic melanoma has increased by over 200 percent, so there is a need for new treatment options," said study author Robert Andtbacka, M.D., assistant professor, University of Utah Huntsman Cancer Institute. "The results of this study are encouraging in a disease as devastating as metastatic melanoma.""

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