(Total Views: 2488)
Posted On: 11/21/2025 12:11:57 PM
Post# of 158771
Misiu asked me to post the one-year numbers for survival without an ICI as seen in the TNBC trial. This isn't an apples/apples comparison, but they are both aggressive cancers, and in this trial like that one Leron is the third-line treatment.
There were 28 TNBC patients. Median survival was 6.8 months, so half the patients died in the first 6.8 months. One year survival was 35.7 percent, or 10 patients; but as we know, 5 of those ten received an ICI. So only 5 patients survived a year without an ICI, or 18%. Or 82% died in the first year without an ICI.
The present trial is 60 patients. 82% of them is 49 patients. Who will probably die without an ICI option incorporated in the trial.
Assuming the dosage is adjusted to 700 mg for all, we can assume that at least 88% of those patients would have a response to Leron, and if they do, it can be extrapolated from the TNBC trial that we could save all of the 88%. Which is 43 patients, whose lives very conceivably depend on the FDA allowing a protocol change.
It might be even a few more, since some of the patients in the TNBC trial received 525 mg -- possibly some of those patients would respond if they had been given 700 mg. That of course is a guess. But the figure of 43 patients dying is not a guess, but an estimate, based on the TNBC trial.
This is why I agree with Misiu here, and disagree with MGK on the Reddit board: I hope very hard that Dr. Jay can convince the FDA to listen to reason, and save those lives. It is in their power.
There were 28 TNBC patients. Median survival was 6.8 months, so half the patients died in the first 6.8 months. One year survival was 35.7 percent, or 10 patients; but as we know, 5 of those ten received an ICI. So only 5 patients survived a year without an ICI, or 18%. Or 82% died in the first year without an ICI.
The present trial is 60 patients. 82% of them is 49 patients. Who will probably die without an ICI option incorporated in the trial.
Assuming the dosage is adjusted to 700 mg for all, we can assume that at least 88% of those patients would have a response to Leron, and if they do, it can be extrapolated from the TNBC trial that we could save all of the 88%. Which is 43 patients, whose lives very conceivably depend on the FDA allowing a protocol change.
It might be even a few more, since some of the patients in the TNBC trial received 525 mg -- possibly some of those patients would respond if they had been given 700 mg. That of course is a guess. But the figure of 43 patients dying is not a guess, but an estimate, based on the TNBC trial.
This is why I agree with Misiu here, and disagree with MGK on the Reddit board: I hope very hard that Dr. Jay can convince the FDA to listen to reason, and save those lives. It is in their power.
(15)
(0)
