I put together this analysis on the human mTNBC trial as depicted in this
CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Month Analysis
I go into an analysis of it In Preparation for the Coming Results on mTNBC
Improved Comparison of the previous PR on 7/19 and The Compassionate Use Study of LL in BC
Here is an excerpt:
I put together this post at about that time to determine how they extrapolated to get 4 year OS
Example using Spreadsheet to Estimate Overall Survivability using available Trial Data for future prediction
Here is an excerpt:
Lastly, previously put together thoughts on BTD
BTD for LL on mTNBC
Here is an excerpt:
CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Month Analysis
I go into an analysis of it In Preparation for the Coming Results on mTNBC
Improved Comparison of the previous PR on 7/19 and The Compassionate Use Study of LL in BC
Here is an excerpt:
Quote:"In standard of care, the majority of TNBC patients do not make it beyond 6-7 months. In the 7/19 PR, all 21 out of the 29 patients who actually responded to the Leronlimab treatment as seen by increases in CAML and / or CTC, remained alive at the 12 month point of analysis. 21 of 29 remained alive at 12 months with a series of (4) 700mg Leronlimab injections with carboplatin, where if they were to have received Standard of Care, they would have died by the 6-7 months point. In the latest PR on Compassionate Use Study of LL in BC, the numbers, claimed are 570-980% increase in Overall Survivability, (OS); this translates into 34 to 59 months of life with scheduled, continuous weekly 350mg Leronlimab injections. That's 3 to 5 years of life with continuous weekly Leronlimab injections."
I put together this post at about that time to determine how they extrapolated to get 4 year OS
Example using Spreadsheet to Estimate Overall Survivability using available Trial Data for future prediction
Here is an excerpt:
Quote:The Press Release gave a range from 34-59 months as Overall Survivability. The mid point of that is at 48 months or at 4 years. On my hypothetical data example of this study, we have at 48 months: the likelihood of surviving is 46.2%. But 95% confidence interval requires adding and subtracting 17.37% which gives us a Range of 28.83 - 63.57%. 50% is within this Range. So this data set could qualify to be comparable with the actual since this Range include 50% at the same 3 month time interval of 48 months.
Now, in my hypothetical data set presented here, the Overall Survivability occurs at the 3 month time interval of 42 months, since Survivability is 49.6%, (closest to 50%). Here the 95% Confidence Intervals are: 17.5% giving a range of likely survivorship from 32.1 - 67.1%. Since 67% occurs at 24 months and since 32% occurs at nearly 57 months, we have a Range of 24 - 57 months, which is somewhat similar to the results of the Press Release, (34-59) months .
Lastly, previously put together thoughts on BTD
BTD for LL on mTNBC
Here is an excerpt:
Quote:In contrast, our Compassionate Use Study reveals an overall survivability of 34-59 months, or 3-5 years . This was determined by use of statistical analysis and extrapolating a death rate to determine time at which 50% of original 30 patients would likely be dead by, and that came out to time range.
The FDA recommended withdrawal due to the current landscape of medications for treating mTNBC. Certainly, the FDA is aware of this most recent LL study and how it utterly blows the doors off the outcome from Atezolizumab with Paclitaxel. We just may have been the reason why the FDA made this recommendation.
With regard to BTD, break through therapy designation, I believe Leronlimab is the best drug for mTNBC out there right now. No one can touch our PFS or OS. We double the stand alone Standard of Care Paclitaxel for PD-L1 BC in PFS and OS. We have no side effects stand alone , but in this Compassionate Use Study of Leronlimab in Breast Cancer, LL was combined according to each Treating Physician's Choice with any one single-agent chemotherapy drug administrated according to local practice: eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin. Side effects of chemotherapy produce considerable morbidity.
27
