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|Amgen Presents Interim Overall Survival Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma|
At a predefined interim analysis of this Phase 3 study, median OS was 23.3 months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm (HR = 0.79, 95 percent CI 0.61-1.02; p=0.0746). Differences in survival rates were pronounced in the subset of patients with stage IIIB, IIIC or IV M1a disease (HR = 0.56, 95 percent CI, 0.38-0.81) or who received talimogene laherparepvec as first-line treatment (HR = 0.49, 95 percent CI, 0.33-0.74), each comprising approximately 50 percent of the study population.
"The interim overall survival subset results complement the durable response data we reported earlier this year and these endpoints appear to correlate with each other in terms of where the most benefit is being seen in this trial," said
The most frequently observed adverse events were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both arms, and cellulitis and pyrexia in the talimogene laherparepvec arm. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.
"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
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
About Talimogene Laherparepvec
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1 National Cancer Institute,