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Amgen Presents Interim Overall Survival Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma
Date:11/18/2013

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"A favorable trend in overall survival was observed in patients who received talimogene laherparepvec and the trend was pronounced in patients with stage III and IV M1a disease where an important clinical need exists for patients whose disease has not yet spread to distant organs," said Howard Kaufman, M.D., professor and director of the section of surgical oncology in the Department of General Surgery, Rush University Medical Center in Chicago. "I look forward to seeing the final results next year."

Trial Design
This trial was a global, randomized, open-label, Phase 3 trial to evaluate the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC or IV melanoma.

Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.

About Melanoma
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing pigment to the skin.1 Melanoma is the most aggressive and serious form of skin cancer in which the best treatment approach involves early detection.2 Because it is not always possible to detect cancer in its earlier stage, it can sometimes spread, or metastasize, to other parts of the body.3 The prevalence of metastatic melanoma patients facing recurrence from an earlier stage of disease is predicted to increase by 43 percent by 2015.4 Metastatic melanoma remains a devastating and difficult-to-treat disease with a high unmet need.

Currently, 132,000 melanoma cases occur globally each year.<
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