Delay in the IMpress AML Clinical Trial?

[kmall]

The IMpress AML Clinical Trial was slated to begin with an "Estimated Start Date" of December 2022, according to the NIH Clinical Trial website:

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=1


"IMpress is a Phase 2 clinical trial evaluating imetelstat as a single agent in patients with acute myeloid leukemia (AML), or higher risk MDS, who are relapsed/refractory/intolerant to hypomethylating agents, or HMAs. The objective of this trial is to evaluate the efficacy of single agent imetelstat in this patient population. The primary endpoint of this trial is overall response rate. IMpress is not yet recruiting."

https://www.geron.com/research-and-deve ... al-trials/


While we wait for a PR on the first patient dosed in the IMpress CT, pay attention to both the UK and EMA, with any periodic updates, both of which mention Imetelstat as a treatment for Acute Myeloid Leukemia.

EMA:
https://www.ema.europa.eu/en/medicines/ ... 0-pip03-20

UK:
https://cms.mhra.gov.uk/pip/mhra-100291-pip01-21

Since it's already Feb 2023, I would expect we see that PR in the very near future. -Kmall

[rccola335]

are you thinking that things might be on hold because it might be approved for AML along with MDS - Janssen advertised for a pricing manger for MDS and induction ineligible AML in 2018 (no MF)

[kmall]

It did cross my mind that the delay here could be tied to an early approval on AML since it's mentioned with MDS by both Regulatory Agencies. The bigger question, if you will, might be why we haven't had a first patient dosed in this study as of now since the TELOMERE Clinical Trial is on an FDA "hold" until an "appropriate dose for single agent imetelstat in AML has been identified in the IMpress study."

From the Geron website:

"TELOMERE is a planned Phase 1/2 clinical trial evaluating imetelstat in patients with relapsed/refractory AML. The trial is designed to test two distinct combinations of imetelstat and venetoclax or imetelstat and azacitidine. The primary objective of the Phase 1 portion is to identify a safe dose of each of the combinations. The primary objective of the Phase 2 portion of the study is overall response rate for each of the combination regimens. TELOMERE is expected to begin after an appropriate dose for single agent imetelstat in AML has been identified in the IMpress study."

https://www.geron.com/research-and-deve ... al-trials/

*I would think that getting the IMpress Clinical Trial underway would be a top priority at this point, especially since TELOMERE is waiting in the wings as well? -Kmall

[biopearl123]

Geron has rarely deviated from guidance timelines (except in a negative way e.g. AML study starts 2017). I don’t expect the delay in IMpress to presage early approval, just the expected delay which of course now impacts follow on AML combination studies as well. Once upon a time Janssen dropped hints that they would seek approval in AML patients who had failed everything. Lo those many years ago. We should have a quarterly financial review coming up at some point that might provide clarity. Obscure clarity, that is. bp