New Drug Successful in Late-Stage Melanoma Clinical Trial

Scientists have developed a drug dubbed successful in killing a deadly cancer in a late-stage clinical trial. The new drug is the first medication recognized as achieving success in a late-stage melanoma trial.

Biopharmaceutical giant Amgen is developing the drug, known as talimogene laherparepvec (TVEC), according to The New York Times. Company representatives say the firm has met the primary objective of a Phase 3 clinical trial involving patients with advanced melanoma.

PubMed Health indicates that melanoma is the deadliest form of skin cancer. The disease develops as the result of changes in melanocytes, cells that manufacture the skin pigment known as melanin. One form of the disease strikes the colored portion of the eye.

The National Cancer Institute reports that 2013 U.S. melanoma estimates include 76,690 new cases and 9,480 deaths. Standard treatment includes surgery, chemotherapy, radiation, immunotherapy, and use of vaccines.

Researchers modified a herpes simplex virus to create TVEC. It contains an implanted gene for a protein, GM-CSF, that stimulates the immune system. After injection directly into skin tumors, TVEC begins to replicate inside cells, which then manufacture GM-CSF.

Virus replication results in burst cells. This frees the virus and GM-CSF to rally the immune system to kill cancer cells.

Amgen's Phase 3 trial included more than 400 subjects. Two-thirds underwent TVEC injections into their tumors at two-week intervals. The remaining third received GM-CSF injections, though not directly into their tumors.

Sixteen percent of trial subjects who received TVEC showed a significant tumor shrinkage for as long as six months. The figure for the control group was 2 percent.

Amgen says that despite the trial success, a conclusion regarding whether TVEC definitively improves survival might not be possible until late in the year. A company representative indicated that no decision has been made yet regarding whether to file for regulatory approval based on the trial.

Healthcare experts caution that while trial results were positive, TVEC might not prove highly successful in treating melanoma. One reason is that only about a third of patients with advanced melanoma have tumors in spots injections can reach.

Days before my honeymoon, I discovered a dark spot beside my left knee. Although the dermatologist just assumed it was benign, the pathology report indicated the mole was at most days from becoming melanoma. This caused great concern, since I take medication to intentionally suppress my immune system.

Following this episode, I've had to undergo strict vigilance for any skin irregularities and visit a dermatologist more than once a year. Like most patients who experience scares related to this disease, what I fear most is discovering it too late for an effective treatment. The discovery of a new drug successful in a late-stage melanoma trial is an encouraging step despite no projections on its further development and availability.

Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.

Source: http://news.yahoo.com/drug-successful-stage-melanoma-clinical-trial-164100582.html

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