I suppose it never hurts to ask about BTD, but if the odds are low then the failure could potentially be used by shorts to further fuel their narrative, which it appears we are seeing now.
One of the problems with the mTNBC cancer indication for leronlimab is that we are combining data from usage in 3 different trials/protocols:
(1) mTNBC randomized trial with chemo, at 3 different doses, as first line therapy: https://clinicaltrials.gov/ct2/show/NCT03838367
(2) basket trial: https://clinicaltrials.gov/ct2/show/NCT04504942
(3) compassionate use combo mTNBC as third line therapy: https://clinicaltrials.gov/ct2/show/NCT04313075
There are different inclusion/exclusion requirements for each, such as whether patients are naive (no prior treatment) in metastatic setting or have had recurrence already.
Trodelvy was approved for recurrent mTNBC (after failing two prior therapies), with a 529 patient randomized trial. It showed improvement in mPFS over a third line of chemo from 1.7 to 4.8 months. https://clinicaltrials.gov/ct2/show/NCT02574455
Yes we are comparing leronlimab to Trodelvy in mTNBC, but in doing so, we should compare the same patient population, those who have recurrent mTNBC who have been treated with 2+ prior drugs that failed. Our randomized mTNBC trial studies chemo naive patients in metastatic setting who are getting combination of chemo and LL, and so it's hard to separate the effects of chemo from the effects of leronlimab there.
We only have a hodge-podge group of patients at different stages of mTNBC. Some are earlier in disease (not recurrent) and are being treated with carboplatin or other chemo drug concurrently, so it isn't an apples to apples comparison.
The second problem is relatively small numbers, and incomplete data. The basket trial stopped recruiting. Compassionate use is still open. I believe the mTNBC trial has paused recruiting as well, but I'm not sure about that. We have applied based on results from 28 patients with mTNBC: 12 from randomized trial, 2 from basket trial, and 16 from compassionate use. We don't have final results yet since patients are still alive and disease not yet progressing, which is a great thing!
The third problem is that it's hard to get all the numbers straight, and NP's exaggerations don't help. Improvement by 2300% ?? turns out that was the upper confidence interval from a small number of patients.
So I can see why the FDA passed on our heterogenous group of patients with mTNBC. We simply need more patients with a consistent protocol (comparable to Trodelvy trial if that is the standard to which we will be held and the indication we are seeking).
Trodelvy is third line therapy in the mTNBC setting. Leronlimab is being investigated as first line in combo with carboplatin, so it really is a different group of patients. I think the comparison for our first line patients and that trial should be to carboplatin alone or other chemo alone in first line therapy for mTNBC.
For the compassionate use data, those can be compared to Trodelvy data, with patients in third line setting (3rd chemo drug 1.7m mPFS, Trodelvy 4.8m mPFS).
I see very promising cancer results especially for mTNBC and the CTC biomarkers, but we just need more data and longer follow-up, and unfortunately these trials can be expensive without a partner and adequate funds.
I would love to hear the plans for future cancer trials and funding. Leronlimab is extremely promising for cancer, and the reason I invested.
One of the problems with the mTNBC cancer indication for leronlimab is that we are combining data from usage in 3 different trials/protocols:
(1) mTNBC randomized trial with chemo, at 3 different doses, as first line therapy: https://clinicaltrials.gov/ct2/show/NCT03838367
(2) basket trial: https://clinicaltrials.gov/ct2/show/NCT04504942
(3) compassionate use combo mTNBC as third line therapy: https://clinicaltrials.gov/ct2/show/NCT04313075
There are different inclusion/exclusion requirements for each, such as whether patients are naive (no prior treatment) in metastatic setting or have had recurrence already.
Trodelvy was approved for recurrent mTNBC (after failing two prior therapies), with a 529 patient randomized trial. It showed improvement in mPFS over a third line of chemo from 1.7 to 4.8 months. https://clinicaltrials.gov/ct2/show/NCT02574455
Yes we are comparing leronlimab to Trodelvy in mTNBC, but in doing so, we should compare the same patient population, those who have recurrent mTNBC who have been treated with 2+ prior drugs that failed. Our randomized mTNBC trial studies chemo naive patients in metastatic setting who are getting combination of chemo and LL, and so it's hard to separate the effects of chemo from the effects of leronlimab there.
We only have a hodge-podge group of patients at different stages of mTNBC. Some are earlier in disease (not recurrent) and are being treated with carboplatin or other chemo drug concurrently, so it isn't an apples to apples comparison.
The second problem is relatively small numbers, and incomplete data. The basket trial stopped recruiting. Compassionate use is still open. I believe the mTNBC trial has paused recruiting as well, but I'm not sure about that. We have applied based on results from 28 patients with mTNBC: 12 from randomized trial, 2 from basket trial, and 16 from compassionate use. We don't have final results yet since patients are still alive and disease not yet progressing, which is a great thing!
The third problem is that it's hard to get all the numbers straight, and NP's exaggerations don't help. Improvement by 2300% ?? turns out that was the upper confidence interval from a small number of patients.
So I can see why the FDA passed on our heterogenous group of patients with mTNBC. We simply need more patients with a consistent protocol (comparable to Trodelvy trial if that is the standard to which we will be held and the indication we are seeking).
Trodelvy is third line therapy in the mTNBC setting. Leronlimab is being investigated as first line in combo with carboplatin, so it really is a different group of patients. I think the comparison for our first line patients and that trial should be to carboplatin alone or other chemo alone in first line therapy for mTNBC.
For the compassionate use data, those can be compared to Trodelvy data, with patients in third line setting (3rd chemo drug 1.7m mPFS, Trodelvy 4.8m mPFS).
I see very promising cancer results especially for mTNBC and the CTC biomarkers, but we just need more data and longer follow-up, and unfortunately these trials can be expensive without a partner and adequate funds.
I would love to hear the plans for future cancer trials and funding. Leronlimab is extremely promising for cancer, and the reason I invested.
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