American laboratories Merck and Moderna announced this Wednesday positive results in the final phase of clinical trials of their experimental messenger RNA vaccine against skin cancer, aimed at patients with high-risk melanoma who had the tumor completely removed by surgery. “This is the first announcement of positive phase 3 results (…) for an mRNA-based cancer therapy,” Merck and Moderna state in a joint statement.
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The companies claim it reduces relapses and metastases, but have not yet published the figures
Their personalized therapy, combined with Merck’s Keytruda immunotherapy, allowed a “statistically significant” improvement in relapse-free survival in patients with stage IIB, IIC, III, or IV melanoma who had previously undergone surgery, compared to treatment with Keytruda alone, both laboratories noted, without publishing numerical data.
The combination also significantly improved distant metastasis-free survival, one of the main secondary objectives of the study. This means it delayed the appearance of new tumors in organs or tissues distant from the original melanoma, although the companies have not specified the magnitude of this advance either.
The results come from an interim analysis planned in the trial protocol. So far, Moderna and Merck have not reported how many patients relapsed in each group, the follow-up time, the relative or absolute risk reduction, nor the detailed rates of adverse effects.
The study will continue to determine whether the treatment improves overall survival, that is, whether it helps patients live longer. Achieving the relapse and metastasis objectives does not yet allow answering this last question.
The treatment is based on messenger RNA technology, which gives ‘instructions’ to cells to produce proteins capable of triggering an immune response
This new treatment, called intismeran autogene, is based on messenger ribonucleic acid (mRNA) technology, which consists of giving instructions to the body’s cells on how to produce proteins capable of triggering an immune response. It is a “tailored” therapy, designed from the specific mutations of each patient’s tumor.
To manufacture each vaccine, a tumor sample is analyzed and mutations not present in healthy cells are identified. From that information, up to 34 neoantigens are selected, abnormal proteins that can act as distinctive cancer signals. The messenger RNA contains the instructions to produce them and present them to the immune system, so that lymphocytes learn to recognize tumor cells.
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It is therefore not a preventive vaccine intended to avoid the appearance of melanoma in healthy people. It is a therapeutic and adjuvant vaccine administered after surgery to try to eliminate microscopic cancer cells that may have remained in the body and cause a relapse.
The goal is to train and activate the patient’s immune system to recognize and attack cancer cells. “For many years, the idea of creating an mRNA treatment specifically designed for a person’s cancer was hard to imagine. Today we are helping to turn that vision into reality,” said Stéphane Bancel, CEO of Moderna, quoted in the statement.
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The phase 3 clinical trial, a decisive stage before applying for marketing authorization of the treatment, was conducted with 1,137 patients from different countries. According to the companies, no new safety issues have been detected compared to those observed in previous studies. However, it will be necessary to know the complete results to compare the frequency and severity of adverse effects between the two groups.
The new study, seven times larger, reinforces those 2022 results by confirming them in a phase 3. But intismeran remains an experimental treatment and is not yet authorized. Moderna and Merck plan to present the full data at an international medical congress and submit them to regulatory authorities.
Moderna became known to the general public by becoming one of the world pioneers of messenger RNA vaccines. It was, in particular, one of the first companies, along with Pfizer-BioNTech, to develop and market on a large scale a vaccine with this technology against COVID-19.
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