Merck and Moderna's personalized mRNA therapy cuts melanoma recurrence risk 42% in Phase 3

Merck and Moderna released detailed Phase 3 results on Oct 22 showing that their individualized mRNA cancer therapy intismeran autogene, added to Merck's immunotherapy Keytruda, cut the risk of recurrence or death by 42% versus Keytruda alone in patients with surgically removed stage IIB-IV melanoma [1]. The companies published the data two days ahead of the scheduled Oct 24 presentation at the European Society for Medical Oncology congress in Madrid, after an embargo breach [2][3].

• The INTerpath-001 trial randomized 1,137 patients 2:1 to the combination or to placebo plus Keytruda [4].
• Median follow-up was 24.6 months, and overall survival data are not yet mature [1].
• Recurrence-free survival at 24 months was 82.2% with the combination and 70.0% with Keytruda alone [2].
• The risk of distant metastasis or death fell 38%, against a 65% reduction in the earlier Phase 2 study [2].
• Grade 3 to 5 treatment-related adverse events occurred in 14.2% of patients on the combination and 13.4% on Keytruda alone [2].

The two companies develop intismeran jointly and said they are engaging with regulatory authorities, without giving a filing date [1]. Moderna shares fell 17.6% on Oct 22 and Merck shares fell 1.76% [5]. Merck reports third-quarter results on Oct 29 and Moderna on Nov 6 [6][7].