Jul. 29 at 10:00 PM
$SMMT
Keeping a close eye here
ORR 50.6% vs 35.4%p < 0.001
CRR 0.6% vs 0%Not statistically significant
PFS 7.1 months vs 4.8 months with HR = 0.46 54% reduction in risk of progression• p < 0.001
OS Primary Analysis 16.8 months vs 14.0 months with HR = 0.79, p = 0.057 (Missed strict statistical significance boundary)
They framed the OS miss as a technical failure of trial timing rather than a lack of drug efficacy due to a geographical data dilution and maturity mismatch between patient populations.
PFUDA 14th Nov
Granted FTD due to unmet needs.
$CMPX
Highly unmet needs, BTC Ca
ORR 17% vs 5%
PFS 4.7 months vs 2.6 months, HR 0.46, significance in p-value
OS missed 8.9 vs 9.4 in control. They called this statistical failure rather than clinical failure as 56% of contorl (initial OS 6.1) crossed over and lifted OS to 12
