A real hope in the field of oncology. The boss of Moderna, Stéphane Bancel, considered it possible with AFP that the therapeutic vaccine developed by the company against skin cancer would be approved as early as 2025, after new positive results announced on Thursday. This therapeutic vaccine is not intended to prevent the development of the disease like a conventional vaccine, but to treat it once it appears. However, it uses the same principle: helping the patient’s immune system defend itself against the disease. “It is believed that the product, in some countries, could potentially be launched under accelerated approval by 2025,” Stéphane Bancel said in an interview.
This timetable is particularly encouraged by results published by Moderna on Thursday, showing an improvement, over time, in the chances of survival thanks to the treatment which uses messenger RNA technology which has proven effective against Covid-19.
In a trial of around 160 people with advanced melanoma, taking the vaccine at the same time as the anti-cancer drug Keytruda reduced the risk of the disease coming back by 49% over a three-year period. cancer or death, compared to patients treated only with the anticancer drug. Moderna had already announced two-year monitoring results last year, with a 44% reduction in risks.
It works for one in two people
“The difference in survival is growing. The more time passes, the more you see that the advantage” of Moderna’s treatment is “important”, estimated Stéphane Bancel. A treatment that works for “one in two people”, compared to those who have received “the best treatment on the market”, in oncology, “that’s huge”, he stressed. This data could therefore allow, according to him, a launch of the treatment without waiting for the results of a phase 3 trial. This was started in July on more than 1,000 people, and recruitment should be completed “in the second half of 2024”.
“At that time, we can begin to have discussions with the regulatory agencies on accelerating the conditional approval of the product,” explained Stéphane Bancel. The condition for confirming the authorization then being “a success of phase 3, which would confirm the data we see today”.
The treatment has already been designated an “innovative therapy” by the United States Medicines Agency (FDA), a status which aims to accelerate its development. The European Medicines Agency (EMA) has also granted it a similar designation (Priority Medicines).
An individualized vaccine
In 2020, around 57,000 people died worldwide from a case of melanoma, one of the most serious forms of skin cancer, according to estimates from a recent study. Moderna’s therapeutic vaccine is developed from mutations read in the DNA of the patient’s tumor, who undergoes an operation to remove it before receiving treatment. Thus, more than a personalization of the vaccine, this is an “individualization”, underlined Stéphane Bancel. Moderna “physically makes a product” that is made “just for you.”
To prepare for commercialization, the company is building a factory in Massachusetts dedicated to these individualized cancer treatments.
Other types of tumors are also in consideration. The company announced Monday that it was starting a phase 3 trial against lung cancer.