New vaccine against skin cancer enters final phase of testing

A skin cancer vaccine mRNA-4157 (V940), began to be tested in patients with melanoma advanced in its last phase of clinical testing before being submitted for approval by regulatory bodies. The vaccine, developed by the pharmaceutical company Moderna in conjunction with MSD, uses the same technology as current vaccines against Covid-19 — the use of messenger RNA (mRNA) — but its difference is that it is a personalized technology, that is, adapted to needs of each patient.

The phase 3 study evaluates the effectiveness of the vaccine combined with Keytruda (pembrolizumab) — an immunotherapy drug against skin cancer — compared to the current treatment, which uses only immunotherapy. In phase 2 clinical trials, the combination demonstrated a 44% reduction in the risk of skin cancer recurrence or death in patients with stage III or IV melanoma after three years, compared to those who only received Keytruda.

After the results of phase 3, the vaccine will be submitted for evaluation by regulatory authorities and, if approved, will undergo phase 4 trials, which allows adverse events to be monitored for a longer period in patients who received the vaccine.

Hope to stop cancer from returning

Melanoma is the most serious type of skin cancer, due to its high possibility of causing metastasis (spreading to other organs). In Brazil, this type of tumor represents 4% of malignant neoplasms in the skin, according to INCA (National Cancer Institute).

British Steve Young, 52, is one of the first to receive the skin cancer vaccine in this final phase of testing. He was diagnosed with stage 2 melanoma on his scalp last year and is one of the participants in the phase 3 clinical trial.

In press releaseYoung explains that he decided to participate in the study because he considers this to be his best chance of preventing the cancer from returning.

“I feel lucky to be part of this clinical trial. Of course, I didn't feel so lucky when I was diagnosed with skin cancer; It was actually quite a shock, but now that I've had treatment, I'm eager to make sure it doesn't happen again. This is my best chance to stop cancer,” he says.

How does the skin cancer vaccine work?

The skin cancer vaccine developed by Moderna and MSD is a type of personalized treatment that is, the composition of the immunizer is changed to suit the needs of each patient.

With this, the vaccine instructs the body to produce up to 34 proteins, each targeting “neoantigens”, identified through genetic sequencing, that may be causing cancer in the treated patient. Neoantigens are proteins found on cancer cells and the personalized vaccine prepares the immune system to attack these cells in each patient.

“This is an individualized therapy and much smarter, in some ways, than a vaccine,” Heather Shaw, an oncologist and national coordinator of the phase 3 clinical trial of mRNA-4157 (V940), told the British newspaper The Guardian. “It’s absolutely personalized to the patient – ​​you couldn’t give it to the next patient in line because you wouldn’t expect it to work.”

By using Keytruda combined with the immunizer, it is possible to block an action of the immune system that could protect cancer cells.

“The idea behind this immunotherapy is that by stimulating the body to produce these proteins, it can prepare the immune system to quickly identify and attack any cancer cells that contain them, with the goal of preventing melanoma from recurring,” explains Shaw , in a statement.

Trials are being carried out in several locations across the UK. Additionally, there are about 1,089 patients enrolled for the phase 3 clinical trial, called INTerpath-001, across the world.

The study is randomized, double-blind, placebo-controlled and active comparator. This means that all patients will receive Keytruda, but some will receive the vaccine and others a placebo — randomly, without knowing what each one is receiving.