Question · Q3 2025
Cory Kazimov inquired if the HARMONi-6 data prompted the protocol amendments to the HARMONi-3 study, beyond just staggered enrollment rates, and what impact these changes would have on the powering of the HARMONi-3 subsets.
Answer
Dave Gancarz, Chief Business and Strategy Officer, explained that multiple reasons drove the HARMONi-3 update, including accelerating the front-line lung cancer opportunity, reducing regulatory risks by separating histologies into individual Intent-to-Treat (ICT) analyses (each individually powered for PFS and OS), and keeping pace in non-squamous. He confirmed that HARMONi-6 data allows for a direct read-through to the HARMONi-3 squamous population, accelerating that opportunity.