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Merck and Moderna melanoma therapy meets Phase 3 goals
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Merck and Moderna melanoma therapy meets Phase 3 goals

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  • Merck and Moderna reported Phase 3 results showing intismeran autogene with KEYTRUDA improved recurrence-free and distant metastasis-free survival in melanoma patients.
  • The companies plan to present the data at an international medical meeting and discuss regulatory submissions.
  • The trial evaluated an individualized mRNA therapy designed to target patient-specific tumor mutations alongside KEYTRUDA.

Merck (NYSE:MRK) and Moderna (NASDAQ:MRNA) announced positive Phase 3 results from the INTerpath-001 trial, with intismeran autogene combined with KEYTRUDA meeting its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival endpoint in patients with resected stage IIB-IV melanoma.

The study compared the combination treatment with KEYTRUDA alone in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not received prior systemic therapy.

"Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone," said Professor Georgina Long, INTerpath-001 principal investigator and medical director of Melanoma Institute Australia.

The companies stated that the safety profiles of intismeran autogene and KEYTRUDA were consistent with previous studies, with no new safety signals observed, while the trial will continue to evaluate additional endpoints including overall survival.

Merck and Moderna plan to present the Phase 3 data at an upcoming international medical meeting and engage with regulators on filing submissions for intismeran autogene combined with KEYTRUDA.

Intismeran autogene is an individualized mRNA-based neoantigen therapy designed using mutations identified from each patient’s tumor to activate an immune response against cancer cells.

The INTerpath development program includes nine Phase 2 and Phase 3 clinical trials evaluating intismeran autogene with KEYTRUDA, other cancer therapies and as a standalone treatment across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.

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