EMBER-3 and Progress in ESR1-Mutant Disease

The discussion pivots to pivotal recent clinical trials, beginning with Ruta Rao, MD, providing updates from the EMBER-3 study evaluating imlunestrant (oral selective estrogen receptor degrader) with or without abemaciclib. The importance of ESR1 mutation status in therapeutic decision-making is underscored, with analysts covering differences in progression-free survival (PFS) and overall survival (OS), FDA approval status, and likely future regulatory changes. Debate ensues over interpreting numerical OS improvements that fall short of statistical thresholds, and panelists share real-world experience integrating these drugs. The value and limitations of PFS2 and time to chemotherapy as end points in trial design are also discussed, with consensus that evolving end points and access to postprogression therapies must be considered when interpreting results.