Earlier Than Expected Good News for Merck

Following Merck’s decision to include the coprimary endpoint of survival announced during the third-quarter conference call, the expected results of Keynote-189 were pushed back from late 2017 to early 2019. However, an interim analysis triggered an earlier-than-expected positive result. The exact details of the study will be released at an upcoming medical conference.

First-mover advantages are important in gaining market share in immuno-oncology. While Merck has already launched Keytruda in the first-line NSCLC setting in the U.S. based on progression-free survival data from a smaller midstage study, the Keynote-189 study will enable Merck to show the survival benefit of Keytruda in a large study based on a primary endpoint, which carries more significance with the medical community. Further, the Keynote-189 study will allow Merck to file Keytruda in the first-line setting internationally, where regulators have been more reluctant to accept smaller studies as a basis for approval. In international markets, we expect Keytruda and Roche’s competitive drug Tecentriq to launch close to each other in mid-2018. We expect Bristol-Myers Squibb’s competitive drug Opdivo in combination with Yervoy to follow Keytruda and Tecentriq into this indication.

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