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When will there be a breakthrough in the treatment of hard-to-treat cancers?

Merck and Moderna announced Wednesday that a personalized mRNA cancer vaccine, Intismeran, combined with Merck's immunotherapy Keytruda, met the primary goal of reducing melanoma recurrence and a secondary goal of preventing the cancer from spreading in a Phase 3 trial.

Merck and Moderna announced Wednesday that a personalized mRNA cancer vaccine, Intismeran, combined with Merck's immunotherapy Keytruda, met the primary goal of reducing melanoma recurrence and a secondary goal of preventing the cancer from spreading in a Phase 3 trial.

The Phase 3 trial enrolled 1,137 patients with high-risk stage IIB through IV melanoma whose tumors had been surgically removed. Participants were randomly assigned to receive Keytruda plus up to nine doses of the personalized vaccine or Keytruda alone for approximately one year.

The Phase 3 trial enrolled 1,137 patients with high-risk stage IIB through IV melanoma whose tumors had been surgically removed. Participants were randomly assigned to receive Keytruda plus up to nine doses of the personalized vaccine or Keytruda alone for approximately one year.

The latest results build on a mid-stage trial reported in January, in which the combination reduced the risk of melanoma recurrence or death by 49% after five years compared with Keytruda alone. The companies said no new safety concerns had emerged in the Phase 3 trial.

The latest results build on a mid-stage trial reported in January, in which the combination reduced the risk of melanoma recurrence or death by 49% after five years compared with Keytruda alone. The companies said no new safety concerns had emerged in the Phase 3 trial.

Each vaccine dose is custom-made for an individual patient based on genetic sequencing of mutations found in that person's tumor, with the goal of training the immune system to recognize and destroy those unique cancer markers alongside Keytruda's immune-boosting effect.

Each vaccine dose is custom-made for an individual patient based on genetic sequencing of mutations found in that person's tumor, with the goal of training the immune system to recognize and destroy those unique cancer markers alongside Keytruda's immune-boosting effect.

Merck and Moderna began collaborating on personalized cancer vaccines in 2016. The Phase 3 trial marks the first randomized late-stage study aimed at definitively proving the benefit of so-called neoantigen vaccines as a cancer treatment.

Merck and Moderna began collaborating on personalized cancer vaccines in 2016. The Phase 3 trial marks the first randomized late-stage study aimed at definitively proving the benefit of so-called neoantigen vaccines as a cancer treatment.

Moderna shares rose as much as 90% in premarket trading following the announcement, while Merck shares climbed more than 8%. Analysts have estimated an approved product could generate over $3 billion in annual melanoma sales by 2035.

Moderna shares rose as much as 90% in premarket trading following the announcement, while Merck shares climbed more than 8%. Analysts have estimated an approved product could generate over $3 billion in annual melanoma sales by 2035.

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mRNA Melanoma Vaccine Succeeds in Phase 3 Trial

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