New data
The tailor-made mRNA vaccine is intismeran (or mRNA-4157), which uses synthetic mRNA that contains the unique genetic coding of up to 34 mutations in a patient’s cancer cells. To produce the personalized vaccines, researchers compare the genetic sequences of a patient’s cancer cells with those of healthy cells and select cancer-specific mutations that could help the immune response selectively target only the cancer cells.
In the trial, researchers evaluated “recurrence-free survival” or RFS, which is the time a patient has without the cancer coming back, and “distant metastasis-free survival” or DMFS, which is the time a patient has without the cancer coming back and occurring in a different part of the body than where it started.
According to the hastily issued press release, after two years, trial participants who received the intismeran-Keytruda treatment had a 42 percent reduction in their risk of recurrence or death compared to participants who just received Keytruda and a placebo. After two years, 82 percent of patients in the intismeran-Keytruda group were still alive without recurrence, while only 70 percent of patients in the Keytruda-placebo group were alive without recurrence.
For distant metastasis-free survival, intismeran-Keytruda treatment reduced the risk of distant metastases or death by 38 percent compared to the Keytruda-placebo group. At the end of the trial, 88.5 percent of the intismeran-Keytruda treatment group were alive without distant metastases, while 80 percent of the Keytruda-placebo group were alive without distant metastases.
The treatment effect was not as strong as that seen in a five-year phase 2 trial, which showed a 49 percent reduction in the risk of recurrence or death and a 59 percent reduction in the risk of distant metastases or death.
Still, the results represent an exciting advance for melanoma patients. The trial “is the first Phase 3 study to demonstrate clinically meaningful improvement in RFS and DMFS compared to standard KEYTRUDA therapy in patients with resected melanoma, setting a new adjuvant benchmark and representing one of the most significant advances in melanoma treatment since the advent of immunotherapy,” Dean Li, president of Merck Research Laboratories, said in a statement.
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