Back To The Data…Recap From the company's 4/29 interim analysis:
The interim analysis of the Study II Evaluable Patient clinical data (with 3 patients from Study Ib) supports the following provisional conclusions:
| Patient
Assessment Visit | Evaluable
Patients* | Complete
Response (“CR”) | Partial
Response (“PR”) | Total Response
(CR + PR) |
| 90 Days | 35 | 49% | 17% | 66% |
| 180 Days | 30 | 47% | 20% | 67% |
| 270 Days | 23 | 39% | 9% | 48% |
| 360 Days | 21 | 24% | 14% | 38% |
| 450 Days | 21 | 24% | 10% | 34% |
Note: Evaluable Patients are defined as patients who have evaluable data; hence, have been evaluated by the principal investigator and thus excludes patients who have clinical data pending.
For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days.
Excluding previous data reports/timelines, here's my simplified breakdown of the potential CR rates (worst to best case scenario) when considering the first 12 vs the remaining 23 (the fully optimized group):
Evaluable Patients Total CRs First 12 CR Remaining 23 (# evaluable - 12)
90 Days 35 17 3/12 (25%) 14 of 23 (61%)
180 Days 30 14 11 of 18 (61%) to 14 of 18 (78%)
270 Days 23 9 6 of 11 (55%) to 9 of 11 (82%)
360 Days 21 5 2 of 9 (22%) to 5 of 9 (56%)
450 Days 21 " "
Interpretation: Optimization helps : )