CLAIM #27044 · GILD (GILD) · 2023Q4 earnings call · Feb 6, 2024 · due Dec 31, 2024
“We continue to have additional trials that we'll read out this year in Phase 3, specifically the [TROPHY-U-04] (ph) study that we'll be looking at the bladder cancer confirmation study with hopefully an OS signal.”
Merdad Parsey · Chief Medical Officer
In context
“ataset that confirmed where we were before is that we have not seen a difference in response rates between squamous cell carcinoma and non-squamous cell carcinoma. I think that was a bit of an overhang in the fall. And as we had mentioned earlier, we had not seen that to date, and that has been bolstered by the results of EVOKE-01. So we do think that that increases our confidence that we don't need to think about -- look at that. Now there are other analyses we need to do to make sure that there are other predictors of response or not, and we'll be doing that and we'll be sharing that over time. But right now, our overall confidence in Trodelvy, broadly speaking, remains very high. We have three approvals and we have a broad development program against which we are executing really well. We continue to have additional trials that we'll read out this year in Phase 3, specifically the [TROPHY-U-04] (ph) study that we'll be looking at the bladder cancer confirmation study with hopefully an OS signal. That study could actually give us beyond confirmatory trial in the US. It allows us to open conversations with regulators outside the US. And then we have promised an update on ASCENT-03 in breast cancer, which we also think will broaden that. And then we now have a number of trials going on in a variety of indications, including ones we've mentioned in, for example, endometrial cancer. So overall, what we've seen EVOKE-01, and we're looking forward to sharing with you, really maintains our level of enthusiasm about Trodelvy’s term potential from an efficacy and safety standpoint across the board, and we have no plans to change EVOKE-03 at this time. Operator: Our next question comes from a line of Umer Raffat with Evercore. Your line is now open. Umer Raffat: Hi, guys. Thanks for taking”
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SEC filings for GILD ↗ · Claim quote is verbatim from the 2023Q4 earnings call.