In the ASCENT-07 trial, investigators may have prematurely switched patients from the standard chemotherapy arm to superior, commercially available ADCs at the first hint of progression. This real-world practice can mask an experimental drug's true benefit on progression-free survival.
Despite the ASCENT-07 trial failing its primary progression-free survival (PFS) endpoint, an early overall survival (OS) signal emerged. This divergence suggests the drug may confer a survival advantage not captured by the initial endpoint, complicating the definition of a "negative" trial and warranting further follow-up.
Despite both being Trop-2 targeted antibody-drug conjugates, Sacituzumab Govitecan and Datopotomab duroxotein have distinct side effects due to different linkers and payloads. Sacituzumab causes neutropenia and diarrhea, while Datopotomab is linked to stomatitis and ocular issues, requiring unique management strategies.
The ASCENT-07 trial, while failing its primary endpoint, revealed a promising efficacy signal for its Trop-2 ADC in IHC0 tumors. This finding from a "negative" study directly spurred a new trial, Tropion-Brest-O6, to investigate another ADC specifically in this refined patient population, demonstrating the iterative nature of clinical research.