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Posted On: 04/09/2025 4:42:55 PM
Post# of 154620
Quote:
These would be the trial benchmarks LL would be challenging in its own trial??
A four month+- gain for LL would stand against the standard's achievement in gaining its FDA approval? All in addition to zero adverse effects.
That would be the benchmark we'd have to beat unless there's a head to head trial. Treatment related serious adverse events were 7% higher in the Trodelvy arm than in the chemotherapy arm. If treatment related SAEs were exceptionally reduced in our trial compared to Trodelvy than a very modest increase in median overall survival or maybe matching might be enough for approval.
We know that in our underpowered, underdosed results we still did over 12 months for mOS. I am impatiently waiting for the actual results from the ESMO conference. Even without those results we know that 700mg in any new trial will be superior to whatever that number is and should easily beat Trodelvy.
In a past post I had said a trial arm of Trodelvy + chemotherapy forgetting that Trodelvy was a targeted chemotherapy. Since Trodelvy beats standard chemotherapy then any new trial would hopefully be leronlimab + Trodelvy vs. Trodelvy. We've already shown that leronlimab can at least match the Trodelvy results using less effective chemotherapy. Just imagine what the two can do combined. Highly likely that Trodelvy paired with leronlimab becomes the standard of care.

