Moderna’s cancer vaccine may be a ‘major breakthrough’, scientists say

An experimental vaccine nearly halves the risk of skin cancer recurrence in high-risk patients, final study results show.

A phase two clinical trial found that the injection — developed by Moderna — in combination with an immunotherapy drug made by Merck reduced the risk of melanoma coming back by 44 percent compared to those who received the drug alone.

Preliminary findings were published in December, but had not yet been reviewed and confirmed by other scientists. Dr. Ryan Sullivan, an oncologist at the Mass General Cancer Center who is leading the study, announced the results, saying they could lead to inoculations against lung cancer and other types.

Patients in the trial included 61-year-old Brooklyn teacher Gary Keblish, who is now two years melanoma-free after a high-risk case. He said he felt “numb” when he was first diagnosed.

The new injection, designed for people with high-risk melanoma, uses mRNA technology that inserts bits of the genetic code from patients’ tumors into their cells and teaches the body to fight cancer. The vaccine is given to people after surgery to prevent the tumor from coming back, and it is tailor-made for each patient, meaning no two injections will be the same

Scientists are now planning a phase three trial of the injection, but said it could take three to four years to get results. It comes after the Food and Drug Administration (FDA) gave the treatment “breakthrough” status in February.

The results of the study were presented on Sunday at the annual meeting of the American Association for Cancer Research in Orlando, Florida.

Dr. Sullivan said: ‘The relevance of this study is the impact it could have not only for melanoma patients, but also for other cancers.

Gary Keblish, 61, of Brooklyn, was involved in the process. He has been melanoma-free for two years now after a dark brown birthmark on his back developed the disease

“From a general cancer therapeutic standpoint, this is a potential major breakthrough.”

Dr. Jeffrey Weber, an oncologist and deputy director of the NYU Langone Perlmutter Cancer Center who was also involved in the study, said: “For the first time in a randomized control arm study, the addition of an mRNA neoantigen vaccine appeared to increase the benefit by [Keytruda] without adding significant high-grade toxicity.

“This study is extremely important because it gives hope that this new strategy will yield clinical benefit.”

The phase two clinical trial recruited 157 patients with stage three or four melanoma — in which the cancer had spread to other parts of the body, such as the lymph nodes — whose tumors had already been surgically removed.

The participants were split into two groups: 107 received the experimental vaccine and Merck’s immunotherapy called Keytruda or pembrolizumab, while 50 received Keytruda alone.

The vaccine was tailored for each patient to pick up antigens from the surface of their cancer, with each shot taking about eight weeks.

The shot worked by training the immune system to target all cancer cells in the body, eliminating the cancer and preventing it from returning.

Keytruda was used to block a protein on cancer cells that stops the immune system from detecting them, launching an attack on the cancer cells.

Patients received the experimental vaccine – called mRNA-4157/V940 – in one dose every three weeks for seven months.

They also received a dose of Keytruda once every three weeks for up to 13 months and two weeks.

The results showed that in the group that received the cancer vaccine, 24 (22 percent of the group) had their cancer come back.

But of those who received Keytruda alone, 20 (40 percent) saw their cancer return.

Analysis showed that the experimental treatment reduced the risk of cancer recurrence by 44 percent compared to those who received Keytruda alone.

The results also showed that there was little difference in response rates to treatments in those whose cancers had many mutations and few mutations.

Serious side effects were similar between the two arms of the study, the scientists reported. Fatigue was most common with the vaccine, followed by injection site pain and chills.

Patients involved in the study included Gary Keblish, a 61-year-old teacher from Brooklyn, who was diagnosed with late-stage melanoma in 2019.

Mr. Keblish told NBC news that he initially felt “numb” about the diagnosis, with cancer discovered in a dark brown birthmark on his back that he had had for as long as he could remember.

But then he was signed up for the clinical trial to test a vaccine that could potentially prevent the cancer from coming back.

He was one of the participants who received the experimental vaccine and said he has been cancer-free for two years now thanks to the treatment.

The companies are now in talks with US regulators about a phase three clinical trial of the treatment. But they warned that it would likely be another three to four years before the results of these studies are available.

Dr. Kyle Holen, Moderna’s senior vice president and head of development, said: ‘Today’s results further encourage the potential of mRNA as an individualized neoantigen therapy to positively impact patients at high risk of resection. [tumor removed] melanoma.

‘The strongly observed reduction in the risk of recurrence-free survival suggests that this combination may be a new means of potentially extending the life of patients with high-risk melanoma.

“We look forward to starting the phase three melanoma trial soon and expanding testing into lung cancer and beyond.”