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Tuesday, March 17, 2015 3:40:36 PM
There has been quite a bit of discussion both on I-Hub and YMB about RECIST and Standard of Care.
Below is a link to MDAnderson’s protocol for the open label P1/2 trial.
http://utm-ext01a.mdacc.tmc.edu/Dept/PROT/clinicaltrialswp.nsf/Index/2013-0160?OpenDocument&ExpandSection=3#_Section3
What’s great is that this trial - which the company has told us they’ve collaborated closely with the FDA to design - will:
It looks like MDA, NWBO and the FDA have covered everything there. So I think the trial is safe in its choice of criteria.
What’s also interesting about the updated Direct protocol (modified on 2/2/15) is that there is a Part 2 to the P1 trial. I was concerned about what happens to the patients after they’ve received all their injections in one tumor. Well when one looks at the “Inclusion Criteria” at the 11th inclusion, you can see that in Part 2 (not Phase 2), those patients with multiple tumors will move on to receive additional doses in up to 3 tumors. My guess is, some of those earlier Phase I DCVax-Direct patients have already moved into Part 2. Anyhow, I just think that’s terrific because those P1 patients will be able to continue to benefit from Direct, and under the treatment conditions (multiple injections) seen from the pre-study trials with animals.
Here's the relevant quote:
So we can see from the above first quote from the MDA protocol for Direct is that our carefully designed trial will be using four criteria to evaluate the results…
- Tumor Burden
- RECIST 1.1
- IRrC (Immune Response Related Criteria)
- Pathological Examination of tumor biopsies
For a detailed look at the differences between RECIST 1.0 (from 2000), RECIST 1.1 (from 2009) and IRrC, you can visit this website.
http://www.irrecist.com
Here's a quick snippet for those not inclined to read the whole thing...
And for another careful look at Immune Response Related Criteria, this abstract on Yervoy (ipilimumab) from 2009 may help.
http://clincancerres.aacrjournals.org/content/15/23/7412.full.pdf
It’s apparent that the issues of using only RECIST in measuring immunotherapy’s effects have been realized for several years now, as this abstract dates back to 2009.
The discussion portion at the end even states…
and…
Here's the conclusion:
I think all longs will appreciate that fact that the IRrC criteria is a set of published rules that are made up just to assess the effects of “immunotherapeutic agents.” And RECIST 1.1 has been modified in part as well, I’m sure, for the very reasons that immunotherapies are requiring a different evaluation approach.
In the end, the criteria chosen to evaluate the open label protocol for Direct, appears to be well thought out and is covering all angles. Enough unsubstantiated FUD already.
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