MF PIII study timeline

[biopearl123]

Updates to study posted today:

https://www.clinicaltrials.gov/ct2/hist ... udyPageTop

Note the timeline to primary completion is pushed out by over a year to August 2025. This suggests a few possibilities: 1. Under enrollment to date. This is hard to believe with so many world wide sites involved and so many potential R/R patients available to enroll. 2. BAT arm patients are living longer (combined with study patients living longer also) so more time needed to see a statistical difference in OS. This seems more likely. Anyone else have potential explanations? Geron has emphasized that the study can end when there are the requisite number of deaths which may occur before the end of full enrollment.

[biopearl123]

Since crossover is allowed, I specifically asked the company at the May meeting (a question submitted in writing) as to how in the world this is actually dealt with statistically since even a BAT patient may end up with treatment and therefore live longer. The answer was that the statisticians have addressed that issue. I have no idea what that might mean, but it could be good news but a longer study. I have no idea.

[biopearl123]

Credit and thanks to CKTC for pointing out the crossover allowance to me as soon as the study protocol was published on clinical trials site.

[biopearl123]

At least for now, unless other information comes to light, I am going with the study timeline is prolonged because BAT patients are crossing over to Imetelstat treatment and living longer. Patients already getting Imetelstat are living longer. Everyone is living longer. If OS is the end point, well, its going to be a while before we see it. We’re gonna need a bigger boat.

[biopearl123]

Either that or enrollment is terrible. Given the expansion of the company hiring including in the biostat area this seems less likely but is certainly plausible.

[kmall]

Once again Bp, it seems that your analysis is most likely on target. Taking a look at CT locations:

https://clinicaltrials.gov/ct2/show/NCT ... 3#contacts

There are currently 131 out of 166 locations Recruiting. The majority of these countries are Recruiting 75% or more at this point. Germany and Portugal are at 50%, Taiwan is 25% and only Singapore (2 locations) is "Not Yet Recruiting" fully or 0%. Point being here, from my perspective lack of recruitment is most likely not the issue for the August 27, 2025 revised Estimated Study Completion Date pushback.

Another thing to consider within the Global MF patient population, is that the numbers are most likely higher than projected as we have seen in Global MDS patient population estimates.

A BMS fact sheet places the Global MF patient population at 1.5 per 100,000 or approx. 120,00 MF patients globally……….this is a 50% increase from where most MF patient population estimates are based (80,000).*
*Based on global population of 8 Billion (2022)

https://www.wikidoc.org/index.php/Myelo ... mographics


Lending credence to this assessment is the fact that P3 IMpact ongoing in a country like India with a population of 1.41 Billion and 9 locations out of 11 recruiting, there should be plenty of patients to fill the study group as needed. -Kmall

[biopearl123]

If you believe…

If you believe that between 49 and 59 patients have been enrolled so far (target 320, or less if study stopped for efficacy after first look—when 35% of patients have died), take another look at this:

https://www.geron.com/file.cfm/53/docs/ ... 0FINAL.pdf

One can see that the Kaplan Meir curves separate decisively by 3 months. This should be enough time and enough patients if the OS rates are similar in the PIII study, to give Geron a nice window as to what is going on. Recall that this study is not blinded. So even though the timeline to “completion” has been extended, it seems doubtful that the study will go on for that length of time.