RE:Above the unachievable??? From this file:
we have evaluable 29 patients.
The breakdown is:
- 8 CR @450-days. They appear on the top of the chart, all in black. 8 / 29 = 27.6%
- 3 IR @450-days. They appear in green, with an arrow, immediately below the 8 CR. 3 / 29 = 10.3%
- 11 TR @450-days. 11 / 29 = 37.9%
The remaining ones (NR) are all the ones that have a red dot. There are 19 (10+1+4+4). They say 18! So something is not perfect. Probably one that was excluded. Nevertheless ... 19 / 29 = 65.5% 18 / 29 = 62.1%
Next round of 450-days should bring:
- 2 CR (they are in black @360-days)
- 2 IR (they are in green @360-days)
So we could then have 33 evaluable patients @450-days then:
10 CR @450-days = 10 / 33 = 30.3%
5 IR @450-days = 5 / 33 = 15.2%
15 TR @450-days = 15 / 33 = 45.5%
19 (or 18) NR = 19 / 33 = 57.6% (or 18 / 33 = 54.5%)
So we would hit the "may not be realistically achievable" 30% @450-days.
Even before Keytruda turned in disappointing response rates, the International Bladder Cancer Group had deemed the FDA's 30% durable response at 18 to 24 months criterion as "likely too high and may not be realistically achievable."