Market competitor news, page-2

"... Whilst SPLASH has met its primary rPFS endpoint, the vast crossover rate in the study (where control patients were offered study drug after disease progression on the control regimen) has left the OS endpoint confounded (on an ITT basis). The regulatory future for PNT2002 therefore remains uncertain...."

This is a trial design challenge that others have faced. I cant find the source, but I think this might have held back the Pluvicto label expansion (or something). The story is that some good hearted practitioners, after recognizing some patients on Treatment A (Pluvicto) improving while those on B (Standard of Care) deteriorated, switched Group B patients to the effective arm (Pluvicto). This meant that people who had deteriorated on SOC then got to benefit from Pluvicto! Nice. Except that, the planned analysis was to be by Intention to Treat (a Gold Standard way to evaluate RCTs). This assigns Group A to Group A, and Group B to Group B, making SOC look better than it actually is, and hence, eliminating the difference!