FEATURE
evaluate alternative dosing regimens and
predictive biomarkers. This resulted in the
enrollment of more than 1,200 patients in
the trial and, 3 years after the trial began,
data from a cohort of 173 patients sup-
ported the initial accelerated approval for
the use of pembrolizumab in melanoma.
Subsequent data from this trial have also
supported accelerated approval for other
indications and approval of a companion
diagnostic test.
This type of seamless development
could provide earlier access to highly
effe