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MRK/MRNA: Concerns over V940 cancer vax Ph3 remain, despite KN942 Ph2 5-year headline RFS maintenance

Headline data may be due to pretrial imbalances between arms

MRK/MRNA: While updated 5-year headline data today from KEYNOTE 942 in melanoma demonstrates maintenance of the RFS difference seen at the 3-year update, we remained concerned that it may continue to be driven by an unusual difference both in the efficacy measure, as well as against an underperforming control arm. 


Questions addressed include:

  • What is unusual about the recurrence-free survival seen in KN942?

  • Why do we think the control arm is underperforming?

  • Are all baseline characteristics adequately balanced?

Our analysis continues to demonstrate inconsistencies that leave us with concerns over the true treatment effect of Moderna’s intismeran autogene (V940) add-on.

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