Moderna‘s experimental vaccine that nearly halves the risk of skin cancer returning in high-risk patients is one step closer to becoming an approved treatment.
The shot, called Intismeran, is combined with Keytruda – an immunotherapy drug used to treat cancer made by pharmaceutical giant Merck – and slashes the risk of death and melanoma returning by 49 percent.
Intismeran met both its clinical trial goals of reducing cancer recurrence and preventing tumors from spreading to other parts of the body, according to interim results from its phase 3 trial released on Wednesday.
This is the first positive late-stage trial for an mRNA cancer vaccine, and also the first to show that adding the shot to Keytruda worked better than the immunotherapy drug alone.
Phase three of the trial involved 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed.
Volunteers were randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year. The companies said no new safety signals have emerged in the trial.
Wednesday’s interim results add to positive data from phase two trials of the same treatment regimen this year.
The shot, called Intismeran, is combined with Keytruda – an immunotherapy drug used to treat cancer made by pharmaceutical giant Merck – and slashes the risk of death and melanoma returning by 49 percent
‘It’s a big moment for medicine, a big moment for patients,’ Moderna CEO Stephane Bancel said on CNBC’s Squawk Box.
The new vaccine harnesses mRNA technology – pioneered by Moderna during the Covid pandemic – that uses pieces of genetic code from patients’ tumors to teach the body to fight off the cancer.
The vaccine is given to people post-surgery to prevent the tumor from returning, and it is tailored to each patient, meaning no two shots will be the same.
It uses DNA taken from each patient’s tumor.
This genetic snippet is then inserted into messenger RNA — the molecule that carries a cell’s instructions for making proteins.
Once inside the body, the mRNA delivers this piece of code to human cells, teaching them to recognize cancer cells and attack them if it returns.
The hope is that the body will be able to recognize and destroy them before they can start to multiply and form tumors.
Side effects from the vaccine included fatigue, followed by injection site pain and chills, according to phase two data.
Bancel, appearing on CNBC alongside Merck’s Research & Development head Dean Li, said the companies have not decided on pricing, saying the data had only become available ‘a couple days ago.’
This is the first positive late-stage trial for an mRNA cancer vaccine, and also the first to show that adding the shot to Keytruda worked better than the immunotherapy drug alone (stock image)
He said the treatment does not use patients’ own cells, unlike some personalized cell therapies, which could allow the manufacturing process to be scaled and the price reduced.
The phase three study will continue tracking overall survival and other key outcomes, with the company set to unveil the findings at an upcoming international medical meeting, though it remains unclear when it will seek US approval.
Alongside melanoma, the pharmaceutical giants are testing the vaccine across other tumors, including bladder cancer, kidney cancer, and non-small cell lung cancer.
More than 1 million Americans are living with melanoma, the most serious form of skin cancer, roughly four percent of whom have advanced forms of the disease.
Promising patients involved in phase two of the study included Gary Keblish, a 61-year-old teacher from Brooklyn, who was diagnosed with late-stage melanoma in 2019.
Mr Keblish previously told NBC News that he initially ‘felt numb’ over the diagnosis, with cancer detected in a dark-brown mole on his back that he had had for as long as he could remember.
But he was then signed onto the clinical trial testing a vaccine that may be able to prevent the cancer from coming back.
He was one of the participants who received the experimental vaccine and said that thanks to the treatment he has now been cancer-free for two years.
