Methodological considerations in the interpretation of ASCENT-03.

Results of the ASCENT-03 trial demonstrated a statistically significant improvement in progression-free survival with sacituzumab govitecan (SG) compared with chemotherapy in patients with previously untreated metastatic triple-negative breast cancer (mTNBC) ineligible for PD-(L)1 inhibitors. This population represents a clear unmet need, as PD-L1 CPS < 10 tumours account for a substantial proportion of mTNBC and many patients do not receive subsequent lines of therapy. However, several methodological considerations temper the strength of the conclusions, underlining the need for mature, crossover-adjusted overall survival analyses before definitively establishing SG as a first-line standard of care.