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As Willis Davis tells it, he’s healthy as a mule. He eats what he wants, and does what he wants. He is free of the potentially deadly skin cancer that he was diagnosed with five years ago.
Davis, 75, was diagnosed with stage IIIc melanoma in September of 2009. It was just before he and his wife, Robbin, had finalized the purchase of a new home in the Virginia community of Ringgold. His cancer was spreading, said Frances Collichio, MD, a researcher with the UNC Lineberger Comprehensive Cancer Center and a clinical professor in the UNC School of Medicine Division of Hematology/Oncology. And Davis wanted more time.
“I said ‘Lord, if you’ll give me a few more years to live, to let me get squared away on this house, then you’ll have your will and your way,’ ” he said.
In a month of the cancer diagnosis, Davis was in surgery at the N.C. Cancer Hospital. But his cancer continued to spread, so Collichio said he needed a treatment that would attack the cancer throughout the body. They turned to an investigational oncolytic immunotherapy available through a clinical trial at the N.C. Cancer Hospital and other medical centers.
The investigational treatment, talimogene laherparepvec, or T-VEC, uses a modified herpes simplex I virus to fight melanoma. The virus has been genetically engineered to be non-pathogenic, as well as to selectively replicate in cancer cells in order to kill them. It has also been modified to trigger the body’s disease-fighting immune system against cancer by releasing a trigger called granulocyte macrophage colony-stimulating factor (GMCSF).
“We recognized that the surgery alone was not going to help, and we needed something we could give him that would treat his whole system,” Collichio said. “We had seen some promising early data for this an investigational treatment for patients with in-transit melanoma like this.”
The phase III trial, whose findings were published earlier this year in the Journal of Clinical Oncology, included 436 patients with stage IIIb to IV melanoma. UNC was one of the top five medical centers enrolling in the study, with 19 patients, according to the pharmaceutical company developing the drug, Amgen. The study found that T-VEC increased median overall survival by about four months compared with injections of GMCSF alone. Sixteen percent of patients had a durable response of six months or more, and 26 percent of patients showed an overall response. The study authors, which included Collichio, state that the treatment is the first oncolytic immunotherapy to show a benefit for patients in a phase III trial for melanoma.
Within several hours of receiving the T-VEC treatment, Davis experienced flu-like symptoms that lasted about two hours, and that then dissipated by the next morning. After four treatments with T-VEC, Davis was considered to be in cautious remission. He is now cancer-free, Collichio said, and they hope he is cured. He said he was told that if T-VEC hadn’t worked, he likely would have had eight to nine months to live.
“The treatment worked wonders on me,” he said. “It’s a miracle.”
Davis said he is grateful for the compassionate care he received from Dr. Collichio, and also advocated for U.S. Food and Drug Administration approval of the treatment to help other patients. The pharmaceutical company Amgen has submitted an application to the FDA for approval of T-VEC for treatment of injectable regionally or distantly metastatic melanoma.
“Dr. Collichio just showed that she cared for me, and did everything she could do for me, including getting me accepted in that program,” he said. “If (T-VEC) is not approved, it would be a travesty to people with melanoma,” he also said.
UNC Lineberger is participating in an additional clinical trial for T-VEC. A multi-center, Phase Ib/II, trial sponsored by Amgen will test T-VEC in combination with the immunotherapy treatment ipilimumab in patients with previously untreated, unresectable, advanced melanoma compared with ipilimumab alone.