Brad Canino's questions to Summit Therapeutics (SMMT) leadership • Q3 2025
Question
Brad Canino questioned the strategic rationale behind submitting the HARMONi study BLA first, given potential OS review issues, instead of waiting for the HARMONi-3 data (PFS and OS) expected in the second half of 2026. He also asked for qualitative details on the undisclosed in-house colorectal phase III data, its extent, and when it might be presented.
Answer
Urte Gayko, Chief Regulatory Quality and Safety Officer, explained that each indication has its own submission, and the HARMONi package is ready, representing a timely opportunity. Bob Duggan, Chairman of the Board and Co-CEO, provided historical context on FDA's support for the HARMONi trial. Dave Gancarz, Chief Business and Strategy Officer, described the colorectal data, mentioning previous ESMO 2024 presentations, expansion to U.S. patients with FOLFOX, and confidence in the regimen, while noting Akeso is also running a phase III.