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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
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.
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.5 In
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response. Talimogene laherparepvec is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells causing lytic cell death and releasing an array of tumor specific antigens. Talimogene laherparepvec is also engineered to express GM-CSF, a white blood cell growth factor that can help to activate the immune system. The aim of this combination of actions is to induce a systemic anti-tumor immune response that targets tumor cells throughout the body.
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1 National Cancer Institute,
2 American Cancer Society. Surgery for Metastatic Skin Cancer. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-treating-surgery. Accessed
3 American Cancer Society. What is Metastatic Skin Cancer. http://www.cancer.org/cancer/skincancer-melanoma/overviewguide/melanoma-skin-cancer-overview-what-is-melanoma. Accessed
4 Lin AY, et al. Melanoma Res. 2012; 22:454-459
5 Ultraviolet radiation and the INTERSUN Programme.