Single-arm studies cannot adequately characterize time-to-event endpoints such as PFS. As such, the clinical significance of these data is not known. These data are not included in the AUGTYRO U.S. Prescribing Information, and this analysis should be interpreted with caution.
ROS1+ NSCLC safety (n=264) in the pivotal TRIDENT-1 study included||:
8% of patients permanently discontinued AUGTYRO1
Serious adverse reactions occurred in 33% and included pneumonia, dyspnea, pleural effusion, and hypoxia in ≥2% of patients1