EHA

[rccola335]

The presentation was this morning - not seeing anything popping up on Twitter

[LWS]

This is all that I could find. Please post as information becomes available.
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Copilot

Certainly! The European Hematology Association (EHA) Conference is an exciting event for professionals in the field. On June 14th, there will be an oral presentation about Imetelstat, a first-in-class telomerase inhibitor. The presentation will focus on long-term efficacy and safety data from 38 patients in the IMerge Phase 2 clinical trial. If you’re interested, you can follow the conference proceedings to stay informed!

[lausanne]

I think. it is just about now. 6PM CEST.
https://congress-apps.ehaweb.org/eha202 ... sion/96161

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES
Speaker information
Valeria Santini (Firenze, Italy)
Room
Hall N101
Date
Friday, 14 June, 15:45 - 16:00 CEST
Part of session

Immune and targeted therapies in MDS

[LWS]

Last week Imetelstat (experimental), this week Rytelo (commercial), next week (???)

The FDA had not been compromised, and approval was granted with minimal restrictions, as far as I can tell. The EHA oral presentation was yesterday. I am still looking for the replay (especially the Q & A). Now off label uses can be considered, with a new focus on combinations and chemotherapy applications.
======================
Previous and Current Considerations

Some important and unique disease modification considerations beyond TI (Transfusion Independence):

1/ 2018 IYG data analysis updates
2/ Overall Survival time longer
3/ Better quality of life
4/ Higher hemoglobin levels
5/ Less fatigue
6/ In combinations
7/ With chemotherapy
8/ Off label uses
9/ Molecular level interactions
10/ Two ways to kill cancer stem cells

[biopearl123]

LWS, where is there information to support your post that OS is longer? I have seen data to suggest no adverse effect on OS but not prolongation. Please clarify or edit your post.

[LWS]

bp -- Overall Survival Time Reviewed -- always a consideration

I believe in other ongoing trials or completed trials there has been discussion of documented longer survival times. However, I am basing that on memory. I will look at past discussions. Any inputs would be appreciated. I am almost sure that some of the studies showed longer Overall Survival Time.

I have not seen or heard the recent (Madrid) EHA presentation. That presentation apparently said that Overall Survival Time was not a negative factor and focused on TI (Transfusion Independence).

[KTArsenal]

LWS:

Please refrain from basing your data points on memory.

Your poor memory will not help to attain an FDA approval in Europe or even on Hub Island.

[biopearl123]

LWS, you may be conflating data from the MF and MDS trials. The data presented at EHA was strictly from the MDS trial.

[rccola335]

they said regarding MDS trial at EHA - they could not determine survival months in the non imetelstat arm

[LWS]

bp --- As you suggest, the discussions about longer survival times must be from the ongoing MF trial. If you have some of those comments, I would like to see them again (for reference). My list was meant to be goals beyond transfusion independence (the critical approval factor that will allow for new combinations & trails) in all blood cancers.
============

LWS, you may be conflating data from the MF and MDS trials. The data presented at EHA was strictly from the MDS trial. --from bp

[LWS]

bp --- Can you confirm or update the information below concerning MF (Rytelo) patients living longer?

I don't believe that was a consideration in the recent (June 14th) MDS EHA paper, which was focused properly on transfusion independence and MDS. So far, I cannot find an English replay. One would hope to find where there is disease modification, there is also a better quality of life and a longer life for all blood cancers.

The 3 blood cancers now in the spotlight are MDS, MF and AML (alone--IMpress, combination with Abbvie -- TELOMERE). ASH2024 is still 6 months away.
===================================== 
gern mf patients are now living 41 months and climbing compared to 12 months for the best available FDA approved treatments. -- from Julie (YMB)

[biopearl123]

LWS, I think you are familiar with the MF data but if you wish you can review some of it here:

https://s201.q4cdn.com/710325604/files/ ... _FINAL.pdf

[LWS]

Thanks bp for the MF information. I had not seen this before.

Unless I am missing something, this is very encouraging news. In the conclusions it states, "observed median OS that approached 30 months ". I wonder what the high points are. In the ODAC (MDS review) there was at least one patient that had survived for about 4 years, as I remember.

The other very important piece of information is the safety profile -- "The safety profile for imetelstat was considered acceptable for this poor-prognosis population". I suppose the safety profile will always be the highest hurdle for all new and novel medicines, such as Rytelo.
===================

Conclusions

 Imetelstat at 9.4 mg/kg IV every 3 weeks has demonstrated clinical activity in
int-2 or high-risk MF patients who are relapsed/refractory to JAKi, notably in
observed median OS that approached 30 months

 Though no formal study has reported survival for patients who are truly
relapsed/refractory to JAKi, median OS of patients who were previously
treated with JAKi has been reported to be 12-14 months1,2

 The safety profile for imetelstat was considered acceptable for this poor-prognosis population

 Imetelstat at 9.4 mg/kg IV every 3 weeks is a promising agent for JAKi failure
MF patients and warrants further testing in clinical trial

[LWS]

"Game Changer", says Dr. Sekeres

Some MDS patients likely have extended lifes from Rytelo, even though no formal study has been done. That is only my view, based upon the comments here.

==============
Thanks Ryan & Kaz

The approval by the Food and Drug Administration of Rytelo (imetelstat) for the treatment of some patients with myelodysplastic syndromes (MDS) could mark a significant improvement in the quality of life for those patients with MDS who are dependent on blood transfusions, an expert said.

“Half the people who responded to [Rytelo] actually went a whole year without needing a transfusion. I think that for that group, it's a game-changer,” said Dr. Mikkael A. Sekeres, chief of the division of hematology for the Sylvester Comprehensive Cancer Center, part of UHealth, University of Miami Health System, in an interview.

The FDA approved Rytelo to treat adults with low- to intermediate-1 risk MDS with transfusion-dependent anemia, requiring four or more red blood cell units over eight weeks who did not respond to, have lost response to or are ineligible for erythropoiesis (red blood cell)-stimulating agents (ESAs).

The approval of Rytelo was based on results of the phase 3 IMerge trial, which included Sekeres among its researchers. The trial enrolled 178 patients with MDS who received intravenous infusions of Rytelo or placebo in 28-day treatment cycles until they experienced disease progression or unacceptable toxicity.
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OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES

Prof. Valeria Santini
Author(s): Valeria Santini, Rami S. Komrokji, Mikkael A. Sekeres, Amer M. Zeidan, Uwe Platzbecker and others
(Abstract release date: 05/14/24) EHA Library. Santini V. 06/13/2024; 422288; S184