I've just added my few cents worth into their thread =P
Today's results are relatively consistent with the 241 patient extended access program, which resulted in fast track designation and a stream-lined FDA phase 3 trial (to expedite its path to approval).
Extended access program (241 patients) showed:
Overall response rate of 65%
100 day survival at 82%
To me this means, 0.65 x 0.82 = 53.3% chance of survival
Today's phase 3 results show (50 patients to date, full trial 55 patients):
Overall response rate of 69%
100 day survival at 78% (or 22% mortality)
To me this means, 0.69 x 0.78 = 53.8% chance of survival
This compares to a 15% survival rate (85% mortality rate) for untreated patients.
In other words, when in the past a child who contracts aGVHD had 15% of survival... going forward, MSB's treatment will mean they will have over 53% chance of survival. I can understand why the FDA fast tracked this treatment, pat on the back to the team at MSB. Fantastic work!
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- Ann: Primary Endpoint Successfully Achieved in MSB P3 GVHD Trial
Ann: Primary Endpoint Successfully Achieved in MSB P3 GVHD Trial, page-31
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