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Posted On: 01/07/2022 4:16:02 PM
Post# of 145909
I think we are saying the same thing here:
Me:
You:
Regarding Erubilin and what is a significant improvement, Erubilin with mPFS of 4.1 months I believe is from a study in metastatic breast cancer, not mTNBC, comparing first, second, or third line with capecitabine:
https://ascopubs.org/doi/10.1200/JCO.2013.52.4892
So, only 25% mTNBC there, and at different stages of naivete / failed treatments. I think it's important to pay attention to the patient populations being studied, so yeah I guess I do make a big deal about it. Maybe I missed another trial that had 4.2 mPFS?
Here they looked at baseline CTCs and showed Erubilin did better when CTCs were low to start:
https://translational-medicine.biomedcentral....018-1663-8
Quite a difference: low CTC patients on Erubilin had mPFS of 25.4 weeks vs. 13.1 weeks for patients with high CTC counts to start.
This could be a general finding and impact our finding of low CTCs and better mPFS from leronlimab.
Also, see https://www.medsci.org/v18p2245.htm
for a trial of Erubilin in 2nd line mTNBC. Only 3.5 months PFS.
So, it's quite complicated.
for which patients, exactly is that?
I believe it is for all patients who got 525 mg dose or higher, but what #s from which trials? We have no idea, just that it was 19 of the 28. It could have been in combination with chemo for some of them, which Trodelvy didn't have.
https://www.globenewswire.com/news-release/20...-mTNB.html
I agree with your point about brain mets making our population more difficult in that regard, 6 of our 28 had brain mets.
I am not a breast oncologist (though I am on committee with one and I currently do research with a group of surgical oncologists), so perhaps we can glean some insights from some people who are. I found the discussion after our initial results article interesting from targetd oncology web site:
https://www.targetedonc.com/view/leronlimab-a...ted-to-fda
https://www.targetedonc.com/view/part-1-front...tatic-tnbc
https://www.targetedonc.com/view/part-2-exper...s-for-tnbc
Me:
Quote:
It showed improvement in mPFS over a third line of chemo from 1.7 to 4.8 months.
You:
Quote:
The primary endpoint in that trial was median progression free survival and had a comparator arm of other drugs consisting of third line treatment.
Regarding Erubilin and what is a significant improvement, Erubilin with mPFS of 4.1 months I believe is from a study in metastatic breast cancer, not mTNBC, comparing first, second, or third line with capecitabine:
https://ascopubs.org/doi/10.1200/JCO.2013.52.4892
Quote:
there were small differences in the percentages of patients who had estrogen receptor–positive and triple-negative disease (46.8% v 50.7%, and 27.1% v 24.5% for eribulin and capecitabine, respectively). Overall, 68.5% of patients had HER2-negative disease. Twenty percent, 52.0%, and 27.2% of patients received study therapy as first-line, second-line, and third-line treatment, respectively, for advanced disease.
..
Median PFS was 4.1 months (95% CI, 3.5 to 4.3 months) for eribulin and 4.2 months (95% CI, 3.9 to 4.8 months) for capecitabine (HR, 1.08; 95% CI, 0.93 to 1.25; P = .30; Fig 2B). By investigator review, median PFS times were 4.2 months (95% CI, 3.9 to 4.3 months) and 4.1 months (95% CI, 3.7 to 4.5 months) for eribulin and capecitabine, respectively (HR, 0.98; 95% CI, 0.86 to 1.11; P = .74).
So, only 25% mTNBC there, and at different stages of naivete / failed treatments. I think it's important to pay attention to the patient populations being studied, so yeah I guess I do make a big deal about it. Maybe I missed another trial that had 4.2 mPFS?
Here they looked at baseline CTCs and showed Erubilin did better when CTCs were low to start:
https://translational-medicine.biomedcentral....018-1663-8
Quite a difference: low CTC patients on Erubilin had mPFS of 25.4 weeks vs. 13.1 weeks for patients with high CTC counts to start.
This could be a general finding and impact our finding of low CTCs and better mPFS from leronlimab.
Also, see https://www.medsci.org/v18p2245.htm
for a trial of Erubilin in 2nd line mTNBC. Only 3.5 months PFS.
So, it's quite complicated.
Quote:
In our study leronlimab's mPFS was 6.2 months
for which patients, exactly is that?
I believe it is for all patients who got 525 mg dose or higher, but what #s from which trials? We have no idea, just that it was 19 of the 28. It could have been in combination with chemo for some of them, which Trodelvy didn't have.
https://www.globenewswire.com/news-release/20...-mTNB.html
I agree with your point about brain mets making our population more difficult in that regard, 6 of our 28 had brain mets.
I am not a breast oncologist (though I am on committee with one and I currently do research with a group of surgical oncologists), so perhaps we can glean some insights from some people who are. I found the discussion after our initial results article interesting from targetd oncology web site:
https://www.targetedonc.com/view/leronlimab-a...ted-to-fda
https://www.targetedonc.com/view/part-1-front...tatic-tnbc
https://www.targetedonc.com/view/part-2-exper...s-for-tnbc
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