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|Amgen Presents New Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma|
New data presented include investigator assessments of response: the durable response rate (DRR) was 19 percent with talimogene laherparepvec as compared with one percent for the GM-CSF arm, and the objective response rate was 31 percent versus six percent in the GM-CSF arm. Overall there was a high degree of correlation between the independent and investigator assessments. Key secondary endpoints include time to response and duration of response by independent assessment. The median time to response was 4.1 months (range 1.2 months - 16.7 months). The duration of response was longer in the talimogene laherparepvec arm, with an estimated 68 percent of talimogene laherparepvec responders achieving responses lasting at least nine months compared to 47 percent among the GM-CSF responders.
"These results further support the primary analysis reported at
"This is the first successful Phase 3 study of a novel oncolytic immunotherapy," said
The most frequently observed adverse events were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients.
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.
Currently, 132,000 melanoma cases occur globally each year.5 In the U.S., while melanoma accounts for less than five percent of skin cancer cases, it causes the most skin cancer deaths.5 The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.5
About Talimogene Laherparepvec
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