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[HEALTH] · United States · 6 sources

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Moderna and Merck report positive Phase 3 results for mRNA melanoma vaccine

Moderna and Merck have announced positive Phase 3 trial results for intismeran autogene, an individualized mRNA cancer vaccine. The INTerpath-001 study, which included 1,137 patients with melanoma stages IIB to IV, demonstrated that the combination of the vaccine with Merck’s immunotherapy, Keytruda, significantly reduced the risk of melanoma recurrence and distant metastasis following surgical tumor removal.

The personalized therapy works by using mRNA to encode up to 34 unique protein markers identified from a patient’s specific tumor. This approach aims to train the immune system to recognize and destroy remaining cancer cells. Preliminary data suggested the combination could halve the risk of relapse or death compared to Keytruda monotherapy.

The clinical breakthrough triggered significant market activity, with Moderna’s shares experiencing high volatility and rising as much as 177% in a single session. Analysts have noted the potential commercial impact, with some projecting peak annual sales for the melanoma therapy could reach $5.4 billion. The companies intend to present full data at an upcoming medical conference and will begin seeking regulatory approval from international health authorities.

Entities

Intismeran autogene · Keytruda · Merck · Moderna · Stéphane Bancel

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