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Posted: Wed Apr 20, 2016 8:18 pm
by phil
Looks like a new presentation from Tefferi with imetelstat at ASCO?
This mentions the "randomized study" so my guess is some type of comment on the current MF trial being run by Janssen?
Why is Tefferi presenting and not Janssen?
inquiring minds want to know...

The telomerase inhibitor imetelstat in patients (pts) with intermediate-2 or high-risk myelofibrosis (MF) previously treated with Janus kinase (JAK) inhibitor: A phase 2, randomized study.

Abstract TPS7079

Ayalew Tefferi, MD - Presenter •
Mayo Clinic
Poster Board: #67a



Posted: Wed Apr 20, 2016 9:39 pm
by Fishermangents
Hi Phil,

I checked the ASCO program and my observation is that all the presenters are either from hospitals, universities, clinics or other healthcare institutions. So I suppose it is not usual for this conference that pharma's are presenting. At least Tefferi is independent, so that adds credibility to whatever he is going to say/show. I expect him basically to repeat what was said at ASH2016. Maybe he will get also into the mutational profiles in conncetion with the various responses to imetelstat, about which he presented in Indianapolis on March 12 ('Emerging Issues of Myeloproliferative Neoplasms Research 2016').

Btw: I couldn't find the presentation that you mention. Where can we find it? However, I did find a session on Myeloproliferative Neoplasms chaired by Ruben Mesa:
Saturday June 4, 8:00 AM - 9:15 AM
Progress in Myeloproliferative Neoplasms: Are We Ready?
Track(s): Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant; Clinical Trials; Health Services Research and Quality of Care; Patient and Survivor Care; Tumor Biology
Francesco Passamonti, MD, Fondazione IRCCS Policlinico San Matteo
Ruben A. Mesa, MD—Chair, Mayo Clinic
Especially under the topic 'Clinical Trials' we may expect something to be said about imetelstat.


Posted: Wed Apr 20, 2016 9:43 pm
by Fishermangents
Btw: Janssen will be exhibitor at this ASCO with two stands:
Janssen Biotech, Inc., booth 18079
Janssen Pharmaceuticals, Inc., booth 18084


Posted: Thu Apr 21, 2016 8:02 pm
by Fishermangents
This is what Hoosier thinks about ASCO (posted on SA 20 April 2016):

"For the following reasons, I believe Dr. Tefferi is likely presenting the initial IMbark data at the upcoming ASCO conference.
1) Dr. Tefferi's Mayo trial was NOT randomized.
2) Dr. Tefferi's Mayo trial was NOT limited to patients who failed JAK inhibitors. The NEJM summary indicated 48% of the 33 Mayo patients had received prior JAK inhibitor therapy.
3) Dr. Tefferi's Mayo data has already been presented in NEJM and ASH2015. ASCO is a major conference and requires new (non-published) data for publication.
4) In his 3/4/2016 presentation (see slide #1), Dr. Tefferi identified himself as being in a Prinicipal Investigator role for Janssen: ... efferi.pdf
I was of the opinion Janssen wouldn't present the initial IMbark (MF) data until ASH, or maybe this year's EHA conference at the earliest. However, it appears we may get the initial data at ASCO. Correct me if I'm missing something."


Posted: Sun Apr 24, 2016 8:39 am
by Fishermangents
There will be no presentation of preliminary results of IMbark, as that is not aloud for the type of session Tefferi is in. Here are the rules for so called Trials In Progress Sessions (TPS):

Per ASCO, the following information is not acceptable in a Trials in Progress abstract:
* Any preliminary data including toxicity, response rate, pharmacokinetic, or correlative analyses. NOTE: Abstracts including results or preliminary data will be rejected without further review.

Per ASCO, the following information is acceptable in a Trials in Progress abstract:
* Scientific background/rationale for the trial.
* Preclinical and/or earlier-phase clinical data that has already been publically presented or published may be included with references. The Trials in Progress session should not be used to present preclinical or earlier-phase clinical data for the first time.
* Trial design and statistical methods, highlighting any novel aspects of the design
* Treatment or intervention planned
* Major eligibility criteria, highlighting unusual aspects
* Correlative studies of particular interest
* Current enrollment without providing results or endpoints
* Enrollment must have already begun or have been completed with no data analysis available by the submission deadline of February 2, 2016.
* Phase II studies may report, “8 of planned 32 patients have been enrolled” or “Prespecified activity goal for the first stage of accrual was met; second stage accrual began in January 2016.”
* Clinical trial registry number (required)