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.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (
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In addition, sales of our products are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (
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.