But then came a clinical trial that she
calls “my lifesaver,” in which a modified version of the herpes virus is
used to fight the deadliest form of skin cancer, which strikes 70,000
Americans a year, kills 9,000, and is on the rise.
The
treatment “saved my life,” said Wells, 56, of Ashland, Ky., whose cancer
went into remission. “I was never so thankful in my whole life than for
that medicine. Without it, I would be dead.”
Herpes,
known for cold sores and misery, is being made into a weapon, the latest
example of turning one bane of humanity against another by using
viruses to target cancer.
A study involving 436
late-stage melanoma patients at 64 centers around the globe, published
in the current issue of the Journal of Clinical Oncology, shows that
those injected with a genetically-modified version of the herpes simplex
virus known as T-VEC responded better than a control group. Sixteen
percent saw a significant decrease in tumor sizes within the first year
of treatment that lasted for at least six months, compared with 2
percent of patients who didn't get T-VEC.
Researchers
expect the treatment to yield even better results when combined with
another type of immunotherapy, which uses the body’s own immune system
to fight cancer.
“It appears for many patients that
(T-VEC) gives long-term remission and in some cases, cure,” said Rob
Coffin, who invented the treatment. “Quite a number of people in that
study got a complete response; all their disease went away… I’m a great
believer in the concept of using viruses to treat cancer.”
Over
the years, scientists have explored altering various viruses, including
measles and polio, to combat several types of cancer, including brain
tumors, breast cancers and others. A 2013 review in the journal
Molecular Cancer concluded that cancer-fighting viruses armed with genes
that stimulate the immune system, “are potent therapeutic cancer
vaccines.” Such viruses, including T-VEC, will be discussed at the
annual meeting of the American Society of Clinical Oncology, which runs
through June 2.
T-VEC, a product of California-based
biotechnology company Amgen, is made by removing the gene that causes
herpes from the virus and inserting a different gene that revs up the
immune system, said researcher Jason Chesney of the University of
Louisville, deputy director of the Brown Cancer Center and a co-author
on the study. The virus enters cancer cells and “blows them up,” he
said, at the same time stimulating the body to fight the cancer.
In
the study, patients were injected with viruses once every two weeks.
Those with "durable," or lasting, responses saw at least a 50 percent
decrease in the size of tumors that were injected and those that
weren't. The most common side effects included things like fatigue,
chills and nausea.
Wells, whose cancer first appeared in a
mole on her left leg, was diagnosed with melanoma in 2007. Seven months
later, she said, tests showed it had metastasized and was at Stage 4.
She endured numerous procedures, including surgeries, but the cancer
raged on — until she was accepted into the T-VEC trial beginning in 2010
and received two-and-a-half years of treatment.
“I was the first one accepted (in Louisville) and the first one in remission,” she said.
Researchers
and Amgen have high hopes for T-VEC. Amgen acquired the company Coffin
founded, Massachusetts-based BioVex, in a billion-dollar deal in 2011.
Examining early results of this Phase 3 sponsored study, an independent
advisory panel to the U.S. Food and Drug Administration recommended
T-VEC be approved, and researchers expect word within months from the
agency.
FDA staff had initially expressed concerns about
T-VEC, saying, among other things, that it was unclear from the study
whether the treatment offered improved overall survival benefits to
patients. Median overall survival differed by 4.4 months between T-VEC
and the control group, the study says.
Researchers
and melanoma experts say the best hope for patients may be combining
T-VEC with another type of treatment called immune checkpoint
inhibitors, which Chesney says “release the brakes in the immune
system.” He’s currently testing this combined therapy at Brown Cancer
Center.
Richard Daugherty, a 52-year-old patient of
Chesney’s from Jeffersonville, Ind., is undergoing this therapy for
internal melanoma centered inside his groin and pelvis. When he was
diagnosed in March, another doctor gave him up to a year to live. But
one treatment with T-VEC reduced the size of tumors where it was
injected by about 20 percent — and the only side effect he felt was
fatigue.
Upon hearing the results before his second
injection this week, “I thought I was imagining things,” he said. “The
excitement and hope is amazing. I completely feel like I’ll go into
…remission.”
Timothy Turnham, executive director of the
Washington, D.C-based Melanoma Research Foundation, agrees that
combination therapy seems to be the best approach. He said the results
of T-VEC alone were “interesting but not amazing,” but when used with
immune checkpoint inhibitors “the numbers you get are much stronger,”
and this combined treatment may prove to be a game-changer for melanoma
treatment, especially given the relatively mild side effects.
Melanoma
patient Mary Kenna Deddens, 66, is currently being injected with T-VEC
as part of another study at the Brown Cancer Center and said she hopes
the FDA approves it for wide use, because patients with advanced
melanoma need more options.
“It would help a lot of people,” she says. “It’s another tool in the toolbox.”
Reporter Laura Ungar, who also covers public health for USA Today, can be reached at (502)582-7190 or on Twitter @laura_ungar.
