Expanded Mayo Trial

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j6proulx
Posts: 23
Joined: Mon Jun 25, 2018 10:20 pm

Expanded Mayo Trial

Post by j6proulx » Tue Jul 10, 2018 12:21 am

Hi everyone - First time poster. My account was recently activated (thanks, BP!).

I've been anxious to share a few ideas and get some input and discussion. I was very interested to see that Janssen assumed management of the Mayo trial and expanded enrollment to 81 patients and re-positioned it as a Phase 2 trial. Using the archived history of changes on the clinicaltrials.gov site, you can see that the trial was updated in September of 2015 to increase enrollment from an actual of 56 to an anticipated of 80. Then the site was updated in November of 2015 to list an actual enrollment of 81. I believe 25 patients were enrolled between the 9/23/15 update and the 11/10/15 update. This OUTLINE was also added to the detailed description of the trial: "OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Patients may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study will end when all patients have discontinued study drug, the last patient enrolled has been treated for 5 years, or imetelstat is commercially available in the United States, whichever occurs first."

https://clinicaltrials.gov/ct2/history/ ... 7&C=merged

I would not be surprised if Janssen uses this trial, with additional overall survival data from IMbark, as the basis for an application for accelerated approval. The 25 additional patients were enrolled prior to November 10, 2015. Janssen knows the overall survival status. Patients are living longer than expected. In the June 16, 2017 update to the trial, the primary completion date was pushed back from May 2017 to January of 2019.

I welcome your thoughts. Thanks to all for your contributions. I have enjoyed reading your quality information and analysis for some time.

biopearl
Posts: 367
Joined: Wed Dec 09, 2015 12:12 am

Re: Expanded Mayo Trial

Post by biopearl » Tue Jul 10, 2018 2:33 pm

Welcome j6proulx and thank you for sharing your thoughts. After Dr. Tefferi presented his initial 33 or so patients in the NEJM and reported heretofore never seen CR/PR/CIs it was a very exciting time. As you point out the study continue to enroll fairly large numbers to a total of 81. To my knowledge these were never reported. I submitted a question to Dr. Scarlett as to the status of these patients at a shareholders meeting a few years ago as to why we have not heard about the status of these patients. His response was that the responses were similar to the original 33 and would be reported in the future. He implied that since Mayo was a single center study and since enrollments included patients "from all over the place" (e.g. from lower risk across the spectrum all the way to AML and also included PV patients as well) that it was not particular well designed as was exploratory. I also specifically asked about the PV patients and his answer was murky. Hence the focus on R/R patients in a much better designed study once Janssen got into the picture. You mention it was repositioned as a phase 2 but my understanding is that is was always so. Your observation that the time to completion has been prolonged several times is very important and does suggest support for the improvements in LE we have told of. The study continues as a single site study and recently had its status updated with no specifics. I suspect this is just the required verification required by the FDA but yes this study is most certainly also on FDAs radar via Janssen. Scarlett said the FDA would evaluate the program in its entirety thus implying they would include evaluation of this data too. Thanks for bringing this up since it has been under the radar. This study was due to expand but the famous FDA hold put a stop to that. Best Wishes, bp

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