GSK Defends Against US FDA Doubts About Jemperli Confirmatory Trial Feasibility
ODAC meeting on dostarlimab rectal cancer development program highlights issues at top of mind for the agency, including whether a proposed randomized trial in a different setting can be completed, timeline for development of evidence to verify clinical benefit, and challenges with using external controls for single-arm studies.
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GSK’s Phase II, Single-Arm Trial For Jemperli In Rectal Cancer Gets Panel Nod
Oncologic Drugs Advisory Committee members generally agreed with GSK that a randomized study in dMMR/MSI-H patients would not be feasible; despite the favorable vote, panelists still raised concerns about use of 12-month clinical complete response as the primary endpoint.
GSK’s Clinical Development Plan For Jemperli In Rectal Cancer Draws US FDA Concerns
Oncologic Drugs Advisory Committee asked to weigh in on adequacy of GSK’s proposal for two single-arm trials to support accelerated approval in a curative setting, as well as the potential novel use of clinical complete response as an approval endpoint.
External Controls: FDA Guidance Provides Clarity But Does Little To Remove Hurdles
Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.