Investigational Melanoma Drug Shrinks Tumors in Phase III Trial

Posted on July 2nd, 2013 by

In a Phase III clinical trial, the investigational drug T-VEC (talimogene laherparepvec) produced durable responses in people with advanced melanoma.  These results were presented at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).

Of the more than one million new diagnoses of skin cancer each year, roughly 76,000 involve melanoma. More than 9,000 people die of melanoma each year in the United States. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Important progress has been made in the treatment of this disease in recent years, but researchers continue to seek new and more effective drugs.

T-VEC is a type of immunotherapy that uses a specially designed virus to destroy cancer cells. It is injected directly into the tumor. After acting locally within the tumor, it is intended to prompt an immune response against cancer cells elsewhere in the body.

To evaluate T-VEC for the treatment of advanced melanoma, researchers conducted a Phase III clinical trial that enrolled more than 400 patients. The patients had Stage IIIB, IIIC, or IV melanoma that could not be surgically removed. Patients were treated with either T-VEC or GM-CSF for up to 18 months.

The primary outcome of interest was a durable response (a partial or complete elimination of cancer that lasted for at least six months).

  • Durable responses occurred in 16% of patients in the T-VEC group and 2% of patients in the GM-CSF group. In the T-VEC group, durable responses were most common among patients with Stage III melanoma.
  • The overall response rate was 26% among patients in the T-VEC group and 6% among patients in the GM-CSF group.
  • The most common side effects of T-VEC were fatigue, chills, and fever.

These results demonstrate that T-VEC is active against advanced melanoma. Study participants will continue to be followed in order to assess the effect of T-VEC on overall survival. There is currently a trend toward improved overall survival with T-VEC, but final survival results require longer follow-up.

Reference: Andtbacka RHI, Collichio FA, Amatruda T et al. OPTiM: A randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract LBA9008.




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Tags: Melanoma, Stage III Melanoma, Stage IV Melanoma

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