Story perspectives

Intismeran plus Keytruda hits Phase 3 endpoints in melanoma

8/20/2026

Summary

Moderna Triumphs

Moderna Inc. and Merck & Co., Inc. reported that intismeran-Keytruda met primary and secondary endpoints in the Phase 3 INTerpath-001 melanoma trial.
The trial enrolled 1,137 stage IIB-IV melanoma patients and showed the combo significantly improved recurrence-free and distant metastasis-free survival versus Keytruda alone.
It is the first successful Phase 3 result for a personalized neoantigen and mRNA cancer therapy.
Moderna and Merck shares rose about 40% and 2% respectively in pre-market trading.

Summary

Moderna Seeks Approval

Moderna and Merck have begun FDA talks to file for intismeran approval.
CEO Stéphane Bancel said the vaccine could be approved as early as 2027, depending on the review.
The therapy received breakthrough therapy designation, which could speed review and permit market entry next year.
Merck paid $200 million in 2016 and $250 million in 2022, seeing the vaccine as a growth avenue as Keytruda’s patent expires this decade.

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Moderna Triumphs

Moderna Inc. and Merck & Co., Inc. reported that intismeran-Keytruda met primary and secondary endpoints in the Phase 3 INTerpath-001 melanoma trial.
The trial enrolled 1,137 stage IIB-IV melanoma patients and showed the combo significantly improved recurrence-free and distant metastasis-free survival versus Keytruda alone.
It is the first successful Phase 3 result for a personalized neoantigen and mRNA cancer therapy.
Moderna and Merck shares rose about 40% and 2% respectively in pre-market trading.

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