Earle Burgess: The big news in advanced urothelial (bladder) cancer at ASCO24 isn’t at ASCO24

Earle Burgess, Genitourinary Medical Oncologist, Atrium Health Levine Cancer Institute, shared a post on LinkedIn:

“The big news in advanced urothelial (bladder) cancer at ASCO24 isn’t at ASCO24.

Press release just dropped that the phase 3 trial to confirm that sacituzumab govitecan (SG) improves overall survival in late stage disease compared to old standard of care chemotherapy was negative.

SG wasn’t better.

We’ve known since the earlier phase TROPHY-U-01 trial that SG is active (and safe) in this setting. Anecdotally, I see similar results in my practice.  I like the drug.

What is interesting about the negative phase 3 trial, the press release says an increased number of deaths due to complications attributed to SG were noted and may have skewed the study results.

Immediate questions that I have:

1. If there were a large number of drug-related deaths on the SG arm, how was this managed by the study DSMC?

2. Was there a large amount of post-protocol crossover on the control arm?  Ie, SG has been available through accelerated approval in the US.  Did a significant number of control arm patients enrolled in the US receive SG after coming off study?

3. Correlation between SG drug-related deaths and UGT1A1 genotype?

This is an active drug. Hate to lose it in this space.

Eager to see the study data to understand what actually happened.”

Source: Earle Burgess/LinkedIn