USA— Moderna and Merck have collaborated on a personalized vaccine that can significantly reduce the risk of relapse in patients with melanoma, the most dangerous form of skin cancer.
The vaccine was used in combination with Merck’s Keytruda immunotherapy in a recent study, with results showing a significant decrease in relapse risk for melanoma patients.
The mid-stage trial, involving 157 patients, found that 79% of high-risk melanoma patients who received the combination treatment were cancer-free 18 months later, compared to 62% who only received immunotherapy.
The mRNA vaccine was tailored to each patient’s tumor, with Moderna analyzing the genetic makeup of the melanoma to create a vaccine that trains the immune system to detect abnormal growth markers.
The patients received nine doses of the personalized vaccine every three weeks, in addition to up to 18 treatments of Keytruda, following surgical removal of the melanoma.
While the combination therapy has shown promising results, the companies will need to conduct larger trials to establish the efficacy of the treatment before seeking approval from the US Food and Drug Administration (FDA).
The companies have also announced plans to test the personalized vaccine in combination with Keytruda for other types of cancer, including non-small cell lung cancer.
They aim to commence a lung cancer study shortly after the next melanoma trial begins. This research is part of a larger effort to investigate the potential of personalized mRNA vaccines in cancer therapy.
The collaboration between Moderna and Merck is part of a broader trend in personalized medicine, where treatments are tailored to the individual needs of patients.
While personalized mRNA vaccines are a relatively new field, their potential in cancer therapy has garnered significant attention from researchers and investors alike.
Moderna and Merck’s mRNA cancer vaccine is a critical component of Moderna’s post-pandemic strategy, and its promising results suggest a new approach to treating the deadliest skin cancer, melanoma.
However, Merck Chief Medical Officer Eliav Barr noted that a larger, final-stage trial is necessary to confirm the treatment’s effectiveness before seeking US approval.
Barr emphasized that novel therapies such as this cancer vaccine require a large body of data to be understood by patients, doctors, guideline writers, payers, and regulators to fully comprehend their potential role in practice.
While Moderna executives had previously suggested that accelerated approval based on mid-stage results could be pursued, they will first complete the phase 3 study expected to begin later this year.
Other companies are also exploring the potential of mRNA cancer vaccines, including BioNTech, which developed one of the mRNA vaccines against COVID-19.
BioNTech has partnered with the British government to test potential mRNA cancer vaccines, including those for ovarian and lung cancer.
BioNTech’s mRNA cancer vaccine trials include a personalized vaccine in combination with Roche’s Tecentriq, being tested in patients with pancreatic cancer at Memorial Sloan Kettering Cancer Center in New York.
Gritstone is also testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s immunotherapies Opdivo and Yervoy in a mid-stage trial in patients with advanced solid tumors.
However, despite the potential of personalized vaccines, the reason for their effectiveness against cancer, unlike other failed approaches, remains unclear.
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