Early results show that the new combination drug therapy is safe and effective against advanced melanoma in patients who were unable to remove their tumors surgically.
The researchers say the combination of drugs is among the first to demonstrate the potential value of the common, live cold virus, the Coxsackie virus, in infecting and killing cancer cells.
The Phase 1 study, led by a researcher at NYU Langone Health and its Perlmutter Cancer Center, is among the first to demonstrate how these tumor viruses can safely enhance the action of widely used cancer treatments that help the body’s immune defense system detect and kill. Cancer cells. Currently, these immunotherapies are only effective in shrinking melanomas in more than a third of the patients who receive them.
The results of the new study showed that injection of the experimental drug Coxsackie virus V937, along with pembrolizumab, an immunotherapy drug known as Pimpro or Keytruda, was well tolerated. Moreover, combination therapy reduced melanomas in nearly half (47 percent) of men and women who received treatment every few weeks for at least two years (47 percent).
Most of the side effects, such as skin rashes and fatigue, were minimal, the researchers say, while 13 patients (36 percent) had serious immune reactions in the liver, stomach or lungs, in contrast to the side effects known to occur with pembrolizumab alone.
Scheduled to be shown at the annual meeting of the American Association for Cancer Research online on April 10, the study also showed that eight patients who received both drugs (22 percent) experienced complete remission, with no residual signs of skin cancer.
“The results of our preliminary study are very promising and show that injecting tumor lysis virus, a modified Coxsackie virus, when combined with current immunotherapy, is not only safe, but has the potential to work better against skin cancer than immunotherapy alone,” says the chief researcher at The study and medical oncologist Janice Minert, MD.
Mehnert, professor at New York University College of Medicine Grossman and associate director of clinical research at the Perlmutter Cancer Center, cautions that additional testing, already underway, must prove successful before combination therapy becomes a “standard of care,” or to treatment, for patients with tumor Advanced melanoma, i.e. melanoma that has spread to other parts of the body.
She adds that the next phase of clinical trials will include patients with melanoma that has spread widely, as well as in patients whose tumors can be easily removed by surgery, if shrunk by the combination of drugs.
Among the other findings of the study, the patients least likely to respond to immunotherapy alone were those who responded best to the combined treatment. Patients, for example, who responded better had fewer chemoreceptors (PDL1) on cancer cell surfaces that were blocked by pimprolizumab compared to patients who did not respond as well.
Researchers say more experiments are needed to determine how V937 alters the molecular makeup of the tissues directly surrounding tumors.
“Our goal is to determine whether the virus transforms the tumor microenvironment from a” friendly “to an” unfriendly “one, making cancer cells more susceptible to pembrolizumab, Mehnert says.
As part of the recent study, volunteers, most of them elderly, enrolled at three cancer clinics, including the Rutgers Cancer Institute in New Brunswick, New Jersey. Gabriel Cancer Center in Canton, Ohio; And John Wayne Cancer Institute in Santa Monica, California.
Scientists have known since the nineteenth century that some cancer patients who had an infection, who were later linked to the bacteria or viruses that cause measles and herpes, often experienced tumor shrinkage. Recent technological advances in genetic engineering have allowed scientists to re-equip viruses to target specific molecules on the surface of cancer cells to infect them more easily.
Financial support for the study, known as CAPRA, was provided by Viralytics, the manufacturer of the V937 drug used in the trials, and by Merck of Kenilworth, NJ, which owns Viralytics and produces pembrolizumab, the other drug involved in the research. More information about the trial version can be found online at https://www.facebook.com/
Besides Mehnert, the other researchers involved in the study are study investigators Anne Silk at the Dana Farber Cancer Institute in Boston. Stephen O’Day of the John Wayne Cancer Institute in Santa Monica, California; Howard Kaufman at Massachusetts General Hospital in Boston. Casey Imbergamo, Daniela Portal, Edwin Zambrano Acosta, Marisa Palmieri, Daniel Medina and Joshua Viet from Rutgers University; Seymour Finn of the Seattle Cancer Care Alliance; Kai Wu and Leslie Guerrero at Merck; Andrew Zloza from Rush University in Chicago; Bernard Fox and Carmen Ballesteros Merino at Providence Portland Medical Center in Oregon; Darren Shaverin at ImmVirX in New Lambton Heights, Australia; And Mark Gross at Viralytics in Kenilworth, NJ.