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Saturday, 06/01/2024 5:56:41 PM

Saturday, June 01, 2024 5:56:41 PM

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Here's the link to the JAMA publication: https://jamanetwork.com/journals/jama/fullarticle/2819600
I've spent the afternoon reading it a couple times and here's my $0.02 worth.

The P-values on all the stats are very impressive. The efficacy was P<0.001. Responce rate, ORR, had P<.0.006. "Significant longer PFS duration than chemotherapy alone" was P<0.001. All of these are less than the P<0.05 that is the typical value required. If the Summit P3 trials are still recruiting I would expect there would be considerable effort to get enrolled if you are diagnosed with this type of CA.

I have also seen P3 trials ended early due to ethical considerations but whether or not that applies here is way beyond my pay grade as they say. Frankly, I would struggle with continuing to let the group not receiving Ivonescimab progress their treatments knowing what we know now. Safe to assume that the FDA will require a complete study and analysis. I hope it goes to market quickly which will benefit millions.
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