Pharmaceutical companies Moderna and MSD (known as Merck) have announced that their phase 3 trial (the one prior to drug approval) of their personalized vaccine against melanoma, which is still ongoing, has reached success in several of its milestones. Although the press release they issued to publicize the result does not include data on how much survival has increased or how much the chances of relapse have decreased, it states that the combination of the vaccine (intismeran autogene) with an immunotherapy (pembrolizumab) achieved the goals of relapse-free survival and preventing the cancer from spreading to other organs. After the release of the note, Moderna’s shares soared by 156% and MSD’s by 8%.
Pending further details, this is a historic milestone because it is the first time that a vaccine of this type achieves a positive result in a phase 3 trial, the most advanced. It is also the first time that an oncology treatment based on messenger RNA, the same technology used to make COVID vaccines, has done so.
As a reference, in the previous trial where this treatment was tested, presented last June at the American Society of Clinical Oncology (ASCO) conference, it achieved a 49% reduction in the risk of relapse or death and a 59% reduction in the risk of metastasis.
The new treatment was tested in patients with melanoma (the most dangerous skin cancer) who had already had the tumor surgically removed but were at high risk of relapse. The trial involved 1,137 people divided into two groups. One third received pembrolizumab, a proven effective immunotherapy, and two thirds of the patients received the personalized vaccine in addition to the immunotherapy.
The vaccine does not work exactly like those used against viruses, which are mass-produced and work more or less the same for everyone and are used as protection against the disease. In this case, it is made personalized for a person’s cancer once it has appeared. A sample of the tumor removed from the patient is analyzed to identify its unique characteristics, and with this information, a custom messenger RNA vaccine is designed. This vaccine teaches the patient’s immune system to recognize and attack their specific cancer cells in case they reappear.
Following this initial announcement, MSD and Moderna will present the full data at an international medical conference and will begin discussions with regulatory authorities to seek approval for the treatment. Additionally, both companies already have eight more trials underway with the same personalized vaccine technology in other types of cancer such as lung, bladder, and kidney.
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[Update forthcoming]
