Locations@DocMcstuffins
I only looked up the 180day participants in GVHD001 but the list of original participating hospitals is pretty impressive from the Phase 3 trial . Virtually all the main teaching hospitals accounting for 50% of all cases in paediatric sr aGVHD are very familiar with Ryoncil and should be covered in the first wave of the rollout . As acute steroid refractory GVHD is an unmet need I am struggling to understand what choice doctors have right now for the under 12s... In one of the Reach trials I recall Rux had only 4 patients treated in the under 18 category. Anyone with a brain cell can read up on Reach 1 &2 and see that Ruxolitinib struggles to show any real efficacy in the severe grades of C/D disease . I don't suppose Doc you noticed the percentage of patients that also had to discontinue Rux during the Reach trials owing to toxicity, side effects, etc.
The elephant in the room is that apart from Jakafi , most therapies for GVHD disease rely on blanket immunosuppression…which leads to very poor overall survival outcomes . There may be a case for still using Jakafi in adult for Grade B disease where the response is reasonable and maybe ECP for skin is another alternative, but I believe we trounce all comers in GI/Liver and multi organ disease categories.
Mesoblast has already guided that it will implementing a “stepped roll out”for Ryoncil …but the inventory is already there …and I think treating 241 patients in the EAP, shows that it is not that difficult to find treatment refractory patients when other therapies halve failed.
The Company has plenty of stock ready for distribution…and I think they will be a prime candidate for a Phase 4 trial in adult…it would be plausible to think they may seek accelerated approval for adult whilst committing to a 70-80 patient trial …alternatively they may need do a head to head RCT against Rux with a 180 day endpoint (28 day surrogates are less reliable) After all,seldom are companies approved for a paediatric therapy then prevented by the FDA from being used off label in adults. I am sure you appreciate from J Kurtzberg et al, that paediatric patients with this disease struggle to take pills (Rux is taken by mouth) as opposed to intravenously (Ryoncil) because of extreme fatigue and vomiting …Mesoblast knows from recent clinical data it has similar efficacy in adult patients too. I think your “concerns” are pretty lame !
It’s pretty obvious that many shorters are preparing to change tack in anticipation of a successful BLA application. Eric Rose has already suggested that GVHD will ultimately (post adult approval which is 4X the size) be a $1bn market opportunity…but to be confident we just need confirmation of the reimbursement charges …Nothing comes close to Ryoncil for long term durability of response in severe categories. Failure to prescribe would be akin to incompetence in my opinion. I expect off label sales in adult to build up quite quickly . OP
https://classic.clinicaltrials.gov/ct2/show/NCT02652130
Participating Hospitals in GVHD001Please do not rely on the opinions or facts contained in the above post when making an investment decision.
United States, California Children's Hospital Los Angeles Los Angeles, California, United States, 90027 CHOC Children's Hospital of Orange County Orange, California, United States, 92868 UCSF Benioff Children's Hospital San Francisco, California, United States, 94143 United States, Colorado Children's Hospital Colorado Center for Cancer/Blood Disorders Aurora, Colorado, United States, 80045 United States, Delaware Alfred I. duPont Hospital for Children of the Nemours Foundation Wilmington, Delaware, United States, 19803 United States, Florida Miami Children's Research Institute Miami, Florida, United States, 33155 United States, Illinois Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois, United States, 60611 United States, Michigan Children's Hospital of Michigan Detroit, Michigan, United States, 48201 United States, Mississippi University of Mississippi Medical Center Jackson, Mississippi, United States, 39216 United States, Missouri Washington University Saint Louis, Missouri, United States, 63110 United States, New York Columbia University Medical Center New York, New York, United States, 10032 Memorial Sloan Kettering Cancer Center New York, New York, United States, 10174 The Children's Hospital at Montefiore New York, New York, United States, 10467 United States, North Carolina Duke University Medical Center Durham, North Carolina, United States, 27705 United States, Oregon Oregon Health & Science University Portland, Oregon, United States, 97239 United States, South Carolina Medical University of South Carolina Charleston, South Carolina, United States, 29425 United States, Texas Texas Transplant Institute San Antonio, Texas, United States, 78229 United States, Virginia Virginia Commonwealth University Richmond, Virginia, United States, 23284 United States, Washington Fred Hutchinson Cancer Center Seattle, Washington, United States, 98109 United States, Wisconsin Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
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Locations@DocMcstuffins I only looked up the 180day participants...
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